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Today's podcast we talked In detail about the upcoming Next Level Cruise. We also discussed how to find a balance between learning dating sciences and finding the time to apply what you have learned. Lastly we reviewed the top 3 things you can do this week to supercharge your progress.
JAMIE: I know you and I had something to talk about specific to the cruise, I think that is what you wanted to talk about today. Fire away, man. I know you have some thoughts or concerns and just let me know what they are and let's kind of talk it through a little bit.
JIM: Well, I just want to get a better understanding of what to expect on it. I mean I know there's that going on but I just need clarity on what as students, what will we gain out of going there?
JAMIE: Okay.
JIM: And the parts I've been struggling and I've shared the things that I've struggled with and I've actually dealt with a lot of those over the weekend and I'll share all with you later how I did that but I just wanted to get a better understanding of what it is that we will gain out of it in terms of learning and everything else just so that I can justify all the effort and everything that needs to go into it.
JAMIE: Okay. So here is a good way for us to do that one, man. Rather than kind of go and ramble on about what people can gain, let me just ask you this question. What do you personally want to gain and we'll see if what we're offering matches up with that. So what do you want to get? What is your ultimate outcome?
JIM: My ultimate outcome would be just to get a lot of practice, a lot of being in the situations where I can apply what I've learned and to the point where it's on the unconscious level that I don't have to think of it anymore.
JAMIE: Okay. So there's a few things that what you are asking for, I'm just being very straight forward to you Jim. If you're looking as a final outcome to go on our cruise so that what you can get is a lot of practice, get a lot of situations. On the cruise, that's not going to be a problem, but what you're really looking for it sounds like is some kind of mechanism so that when you're back in the real world you'll continue to get a lot of practice in a lot of situations. Is that correct?
JIM: Well, the idea is if I practice enough. And then it's just going to come naturally when I'm out regardless of the situation I'm in. This will be a great opportunity with the coaches there to also do course correction if needed if there're some things that are said that should not have been said for example or there's some mistakes that I made and then learn from that and continue that on into the real world of that environment.
JAMIE: Okay. So then let me make another attempt here. So your thought is if you practice enough when you're with us on the cruise, when you get out in a real life it will just happen. You will be on some kind of some switch will be hit, you'll be on some kind of auto pilot and you will just make it happen because of all the practice you got on the ship. Is that correct?
JIM: Close. I mean I understand they're not the same.
JAMIE: Okay. So here's the thing.
JIM: Do it has to be… yeah.
JAMIE: You're not going to necessary like this.
JIM: Yeah.
JAMIE: But it's the truth. That's never going to happen. Like—
JIM: Yeah.
JAMIE: Your—there's not a secret button, even if you get really good—
JIM: Yeah.
JAMIE: And very proficient there's no going on auto pilot, you will always have to kind of re-remind yourself so to speak of the way you look at the world, of what's important, of what's at stake, of how to do these things. There is never going to be, there's no auto pilot, it doesn't work like that because the assumption is as it somehow you're going to get enough practice on this thing the things that's been stopping you like fear, approach anxiety—also that's going to disappear because you're so verse at what you're doing that that stuff is going to go away.
JIM: Well, I'm dealing with those situations on my own.
JAMIE: Okay.
JIM: So are there other methods and I've come a long way since the last even females actually.
JAMIE: Then let's talk about that then because I just want to if you feel you've come a long way since the last time you and I have spoke, then I have a feeling that's going to take us to the right direction but just a quick thing here, there's always going to be a level of—it's as if you learn the techniques— You always going to have to do your warm ups, your stretches, kind of pre-gain stuff and you're almost going to have to rev yourself up back again to do what needs to be done. If you don't do those things I mean there is not too much we can do for you, you just got to learn the there's kind of a practice like Erik says it really well.
He's like, you understand that fear and approaching anxiety is never going to disappear. Instead you learn to just embrace it and put on the illusion of confidence knowing that if you can go through the first few steps they will start to take on the life of its own and you will start to kind of feel the part but it's not every something is just going to go on auto pilot because you got enough practice. I mean on the extreme, and I know people that have been doing this s*** for years, even trainers, and if they take six months off, they have to kind of get back on the bandwagon again and it takes some extra concentrated effort to start pushing and going to the emotions. So there's that part of you that will just like, okay, I've done this before. I know it needs to be done, I know it will work; I'm just going to do it. So we can help develop that in you, that's true, but there's always going to be that part of you that's going to have to kind of walk through the door. You know what I'm saying? Let's come back to that.
JIM: Yeah.
JAMIE: Let me hear what you—let me hear about this progress you had because this might answer your question in a way but go on. Tell me what's been happening for the last two weeks?
JIM: Well, basically, I took the class that Jason suggested and a week long. And in that course they really hit hard on the different mental factors that are going through us subconsciously. That limits us from taking the action that needs to be taken to go where we want. They really break it down to a science. We go through a process where mentally we can get over that. So I'm feeling really good learning that and which is why I said that this thing in the past two days, I've come a long way because now I know how to deal with it and I don't feel that's a problem anymore.
JAMIE: Okay. So then—
JIM: I mean I get it. There's always going to be that, the initial fear, like it's always going to be there. I understand. But I now know how to handle it and work with it.
JAMIE: Okay. So then as what you told me in the beginning, not really applicable? I mean if you feel you've handled that now, is that still the outcome?
JIM: So I was coming from the same that I've only dealt with that issue.
JAMIE: Okay.
JIM: And now that I don't have fear that I want enough practice so that I can see the outcome and hopefully more success than not or just learning experiences so that I can see for myself that on my own I can make these work.
JAMIE: Okay. So now you think the fear part is out on your way. Now she is bracketing up the experiences. Is that correct?
JIM: Yeah.
JAMIE: Okay. So here's the thing. As far as you're getting the experiences you need to keep propelling forward in getting the fine tuning so you can keep some kind of corrective measure, you know that interval it's really going to keep you moving forward. We have a lot of that now with VIP to be honest, and the promise you have been using it because you haven't been coming up on the calls with really any experiences, if you actually start coming if you listened to him, you listen to podcast, if you've been making, if you were able from hypothetically from this point on just to come up to the VIP calls and say, hey, I actually had this experience and here's what happened. What did I… what am I missing here? You're going to get a laugh from that alone.
JIM: Okay. Yeah.
JAMIE: That you got to promise in the past you haven't been coming on to the call with anything to talk about. See you're at the point where you were given the tools, we worked with you in person, the only thing that's really missing, man, is that you are just not doing it. But, if you got that solved, which you… and good for you that's wonderful. I mean—
JIM: Yeah.
JAMIE: I've told this before a lot of it would just comes down to just having a mental fortitude to just keep pushing forward knowing you just need to hear—
JIM: Yep.
JAMIE: One little thing from somebody that all of a sudden it f***ing clicks, and you're like holy s***, that's exactly what I need to tell myself. In our last couple of calls, I've given you some ideas maybe they didn't fully resonate for you, but like you can at least appreciate how they might have been what you needed to hear. For example, if I don't do this what's it going to cost me? What if you repeated that mantra to yourself all the time? You might be constantly reminded of what's at stake and the worst thing, the worst regret is not doing anything. So that might have been potentially what pushed you over the edge, right? So to what you're looking for, you know the only reason why you have not benefited nearly as much as you could have just from VIP alone forget even the cruise for example, just because you haven't been pushing yourself and putting yourself in these situations to have an experience to come back to us with. I feel actually that alone will be massive for you. I'll be like—
JIM: Okay. I do have one example.
JAMIE: Okay. Then let us talk about that.
JIM: So this actually happened. I met somebody at the class and yeah, we connected and I was really upfront and we used some of the DHB swift telling and to build enough interest and there were moments there that there's something the I felt and the other person felt and also we got interrupted by somebody else and long story short we had several moments and at the end of the session it ended up that person ended up asking for my contact information which I provided.
JAMIE: Okay.
JIM: But when it came to the like the close, I just closed, I was upfront. I was like hey, I'm attracted to you and I end up right on her face and I was like, I'd like to kiss you, to which she responded she just got out of a relationship and she's not ready for it. So I just said, I understand. So we hugged and I left. So I'm trying to understand was it something that I did on my part that generated that response and, or was it a fact that she—it's true that, she's not there yet. And she did mention that earlier on. So I don't know if there's anything that I could have changed to—that I could have changed to have a different outcome that I want.
JAMIE: Okay, well, that actually is easy enough. So now that you're trying to put yourself out there and do some of these things, remember we talked in terms of routines, right? Routine, something we do over and over and over and over again, because we know it has a damn good chance to work. It's proven material. If it doesn't work that is simply because your delivery was off. Right? You with me?
JIM: Yeah.
JAMIE: So now let's look at what you use there for essentially what would be a kiss close. You said I'd like to kiss you. Did you get that routine from the boot camp? Is there a routine—
JIM: No.
JAMIE: And that's exactly my point. You're not prac—now, the next thing if you're getting out there and putting yourself out there and have other clients that do what you're doing here, the reinventing the wheel, you want to practice perfect. Use the routines you were given. There is no, I mean I don't remember that routine, I'd like to kiss you and whatever.
JIM: Yes.
JAMIE: There other ones like: Are you a good kisser? And the girl says I'm not kissing you. I didn't say if I could, I just want to see how confident you are in your kissing abilities. That is a routine. See the idea is—
JIM: I get it.
JAMIE: The routines allow you to push, but if you get an IOD back, it allows you to kind of recalibrate and act in a way that's you're not being reactive; you are just being playful, fun. You're not letting her know for sure that you even wanted to do those things. So at this point, that's why it's so key to actually practice perfect. Practice the routines you're given, not to reinvent the wheel. It's great that you're feeling like this kind of confidence and you're crazy mechanisms to put yourself out there. That's wonderful, but now the next thing for you to do is actually do what you're taught. Practice the sales script as you were given it. If you don't practice the routines as you were given them well, you can really say anything about well you can't really complain why it doesn't work because you're not doing it the way it was given. So the problem there is you're not practicing the way you were given. Now what you need—
JIM: I guess I—Hmm.
JAMIE: You're challenged now, you want to push forward and you don't necessarily have to do these on the cruise ship. You can really accelerate it tremendously on the cruise but you don't need too, just to be honest to you. If you actually took the most out of VIP and you start doing these things all the time, then you actually start getting coming back and having experiences that you can come back to us with then you can get a lot of feedback that really doesn't require anything addition. For example, in this example, I'm just referring for you not doing the stuff like you were taught. You following me? I don't need to be with you in person to tell you that.
So that is where VIP is incredible because you have all the resource, you have the virtual boot camp which probably you should revisit now. Now that you are ready to—and for anyone listening, the virtual boot camp is an incredible part of what's offered on VIP. It's an opportunity to really over several weeks to literally attend the in-person part, at least the day portion, the workshop and really get a feel for what it'd be like to spend a full weekend with us. It has a ton of routines and done in a very sequential way so that's what we are speaking of right now.
So with that said Jim, what you probably going to want to do is go back to the virtual boot camp, go through all those lessons again re-familiarize yourself and don't reinvent the wheel. If you do, when you open sets now, practice perfect. Do it like you were given, because remember, there are two huge variables: it's your delivery and it's the words, it's your routines. We're giving you the routines to start, now you did the routines stack class all ready so you have that but right now I just want you to do the routines as you were initially given. The reason being, the routines which you are initially given are proven stacks stuff that works for everybody. The only reason it would not work is if your delivery is off, but right now we need to work on your delivery because now you're putting yourself out there. But what's really important is use this new found power to get out there and get the mechanics now. But—
JIM: Yeah. And—
JAMIE: So—
JIM: That's the only thing I need to follow?
JAMIE: Yeah, that's what needs to be done. You don't really need a cruise to do that. You just need for what you're specifically speaking of, here's what you do to work, comes the call with your experiences and from there really take those responses and do something with it. Give back out there, for example like today, after you and I are done here, you should go back out and go do happy hour or something later. Go put yourself out there, we can start practicing this stuff.
JIM: Okay.
JAMIE: So your feedback mechanism is there alone via VIP. Granted you'll have it a lot faster on the cruise. But one thing I want to bring to your attention here as well, is just because we're very clear with you, you know the cruise has really, as a matter of fact I was talking to your… let's just say your friend today. And we came up with the beginning of what our elevator pitch essentially is and I think this is really going to speak, hopefully it's going to speak to you as far as with the cruise is but did I answer your first question though as far as what you're looking for that feedback mechanism? If actually took it upon yourself to use this newfound power you have and start doing it, then you'll come on to the calls with actual experiences you'll get a lot from it that alone. Did that answer your question?
JIM: Yes.
JAMIE: Okay. So you don't necessarily need the cruise to do that. VIP is pretty austere. Dude, you can take advantage of that, take advantage of the forms, start putting your experiences in the form, hey, open up two sets today, here's what happened here, here's what happened there. Jamie, here's my link to my experiences. Can you get me some feedback? You'll strike a lot from that in the premise that you haven't been taking advantage 'til now. Okay? So is that clear?
JIM: Okay. Yes. I'm okay. I do.
JAMIE: You don't need to necessarily do the cruise. Now I'll tell you why you might still want to do the cruise but first things first. The cruise really is two pieces. The first part is the day portion where we're going to do our workshops and self-development stuff. And the way I want to kind of tell to you is I'm going to read to you the beginning of our little pitch here because the pitch I think will really kind of speak to what this whole journey is f***ing about. Things involved quite a bit since VA started ten years ago. We're really a personal development program now. Now granted we have our little niche in dating sciences and I'm not going to say pick up anymore because pick up really just doesn't give full credit and justice to what we do. Dating science I believe does.
Pick up is kind of a cheesy way of saying learning really great ways to meet the kind of people that you really have a great chance to connect with who have similar values, qualities, looking for the same things and the ability to create connections in them very, very quickly. So, with that said, this is the little beginning of the elevator pitch for our cruise coming up. And I'm good at they'll come back to why did you initially do the boot camp with us? But here's the first thing. What if, Jim you could really live in a world a free expression with others verbally, physically. What if you could get the tools to create more beautiful and exciting moments in your life? Okay, you got that?
That's what really the cruise is about. Now if you think about when you did the boot camp, the boot camp was about the same thing just at lower level like dude, I'm first getting back out there. I really just want some tools to talk to people, to feel good about what I'm doing, right? Once you start doing that and you start getting, you starting to create more of a little personal marketing final figure stuff where you're meeting more people and you're getting more dates and you're starting to fill your social calendar, well that's great. That's an awesome outcome, but as you start doing that, what's going to inevitably happen is you're going to start to get more picky. You're going to start saying okay, I got this girl on dating but I'm really not getting it to where I wanted it to be. We have fun together, but I don't really feel like I'm really getting to know her in the way I want to know her. I'd like to share this but I haven't done so. Or I'm meeting a lot of people but not quite the people, not quite the woman that I'm really am attracted too. One day, maybe for example you want to meet someone else significant.
How can you improve the process even more for really finding and connecting with the women that you really want in your life? And that's what it is, it's a mechanism that keep refining and getting even better at doing that more efficiently, quicker, and with the people you do have really taking those relationships to the next level. Learning different types of questions, different types of presenting yourself, ways to really create stronger bonds with people, as well as you know quicker, quickly meet more the kind of people you wanted to meet.
So right now what you did in the boot camp is you kind of created the foundation right. You kind of—you were in a relationship or you've kind of interesting situation but, you're looking kind of put yourself back there. Okay now you're doing that, and now you're learning certain things, you have a certain baseline and once you got that, we come back to the original question from you and I first spoke regardless of what you're able to create for yourself. How about taking it to the next level? Why didn't you like to create even more of that? What didn't you even like to be even better at creating wonderful connections of people? Again verbally and physically. That's what it's about. It's a continuation of what you started.
JIM: Okay. Yeah. That's really nice. Yeah.
JAMIE: But again, it's not just in romantic like for women, it is just across the board. It's meant to be a communication tool to create much better relationships, better communication, more bonding, more of a real relationship with people. And again so verbally, but as well as physically, expressing yourself getting time to have more of those experiences you really want with the people you want to have them with because again, right where you are right now, if you start doing what you say you are able to do and you get back to the base line using the tools you were given, what's going to happen? I'll tell you right now you will start meeting more people, you will start making more make outs, more dates, more sex, all these things you want.
You'll have some fun experiences but what you'll see is you'll have certain circumstances that maybe you didn't go as far as you like to do? Or maybe you have one girl you're dating but just not quite really truly connecting so it is taking that base line we created within the boot camp and really giving you extra layers of understanding and application. It's an improvement. If you want to say from a scale of one to ten billions to connect with people, let's just say you've been given the foundation that got you from two to maybe a five or maybe this will take you from a five to a seven.
Now let me be clear, Jim, the other analogy we want to close up with these here the analogy that I like to use for this when I spoke to your friend with these one. Do you know what a soul mate is? How people speak of it I'm sure you do. It's basically the idea that you have this classically people speak of it, you know somebody who is your better half, but to my understanding the more accurate term for that is called a twin flame. Have you ever heard of that expression before?
JIM: I have not.
JAMIE: Twin flame, in theory, I don't know if this is true, a twin flame in theory is literally your other half, like literally is part of you and you and that person, you and that woman, literally make a whole. Now if that was really true in theory, do you think you have to hide anything from your self?
JIM: No.
JAMIE: No, you can fully express your self physically, verbally without worrying about any judgment and you can have them probably in theory the most incredible fulfilling relationship that is possible, following me?
JIM: Yeah.
JAMIE: I don't know if that is really possible to be honest, I mean depends on your personal believes on the world but I do believed that most people and I am included can get make significant head way in getting even better and just being able to forge those type of relationships even quicker. One of the best examples from our practical stand point and again I'll end it after here and I'll see if you have more questions if I haven't fully answered you here. The best examples I can give you probably is qualifications, one of the reasons why people get stock in the routine especially in qualifications is they have a qualification question they want to ask like, are you a good cook? Do you workout? What is the last good book you read? Whatever it might be, and of course they are more involved qualifications question like such as or more. Questions such as, are you a good kisser? Right. That is a little more risky, you following me?
JIM: Yeah.
JAMIE: Some people feel that is you qualification questions they can ask. Oh is that weird? That might be weird if I say that. I can't ask that. That's in your head. That's because people, most people out there feel that it's not they don't have the right to ask something such as blah, blah, blah. But for every person that says that, there are other people out there that are doing that. That are pulling the trigger on things very, very quickly. So I would argue to say those things that people say you can ask or assume rapport, I'd say you can. It's just a matter of you convincing yourself that you offer enough value to that person.
If they knew who you were, they would want to answer that, and of course that's in your head because if you really believe that you're at that level of value, that you're a man of that level value, they would want to answer you so you can actually assume rapport. When you believe you really can do that, that you have the right do that, that if that person knew who you were they would want to answer those questions or what's going to happen, Jim? You're going to ask better f***ing questions, more involved questions, questions that are going to escalate your interactions, again, verbally and physically a lot f***ing quicker. You following me?
JIM: Yeah.
JAMIE: So again, it's more of that acceleration of that process to learn how to do so and feel like you can do so. So my final hit with you is VIP is awesome. You actually start coming to call with some actual situations and you start posting the form, more situations, you're going to get a lot of what you are looking for so you don't need to do the cruise. If what I said to you resonates with you as far as again that next step to really get more of an understanding, more of the ability to apply. You like where this has been going so far with the obviously putting aside you haven't been applying as much as you could but you like where the learning is going and ultimately where this is taking you then it's going to be an incredible experience for you. But if you're just looking for straight up feedback on your interactions, you'll get a lot of that from VIP alone so that's up to you.
JIM: All right. That really helps.
JAMIE: Okay? Yeah, you're welcome. See, Tom, are you still there?
TOM: Yes.
JAMIE: All right, man. Thanks for being patient, but we'll give you some good time here because I think the other callers going to just listen in. Fire away, man.
TOM: Okay. Well, I just realizing that I didn't really, I think one of the problems I have is I don't really have what you say goal of what I want to achieve but with this program I have bunch of eggs—ideas and idealistic concepts I should clarify what my goals should be. The first question would be you said I thought you previously said something about do you expect to ask the best. Could you go more what you mean by that? Did I ask you like if I could just know the one thing that would improve my relationship skills, you said would you expect the absolute best in terms of getting a relationship.
What do you mean by that? Or what—could you go more into that?
JAMIE: Okay. There are a lot of superheroes who is kind of making this reference where it's not, how does it go? It's not what you say; it's your actions that define you. Okay. Does that sound familiar? I think it was in Spiderman and Batman; it's like an incredibly popular phrase that people like to refer to. Does that make sense?
TOM: Yeah.
JAMIE: Okay. What I think you're referring to from previous conversation, is that we have a lot of people come to different door here and they say they want certain things. Well, if you want a high value relationship or you want a high value people in your life, well you got to be high value, too. People—I mean it's fortunate or unfortunate people are not looking to do you any favors, man. People are looking to better their lives, they are looking to surround themselves with people they are going to add to what they already have and take them down. Then there's not going to be interested, so in other words all the stuff we teach in like these techniques, I mean what good are they if in the core, you don't really believe in yourself. You still following me?
TOM: Yes.
JAMIE: So what you really want to start looking at is, are you really acting the part? Do you really believe that you deserve the best in life? Do your actions line up with that? Did your life demonstrate that you're a guy that expects the best because if they are not, you're just not going to get it? So none of this stuff is going to work. So it's like even with this program, right, like all these things that we offer, or any kind of a program out there that gives you the chance to really develop your skills, and learn, and grow.
Just the fact that you are doing it says something about you and on the other end, to anyone listening here, if you're not doing, and yet you are complaining about your life, that says something else about you. And no offense or anything but that's just the truth of the matter because the problem is when you speak to women and they are getting to know you, no one is a good actor and if you communicate to her you're the kind of guy that is just kind of talking or does actually do things to invest in themselves, doesn't do things that shows he truly believes himself through and through, she's going to see right through that s***. And that's not attractive.
So one of the first things you want to really look at is like does your life demonstrate the action that you're a guy that really believes? If you are not investing yourself, you're not doing things that showed you really believe, you just talked about your dreams. You just talked about educating yourself. Did you actually do anything? Well that's going to have a very adverse effect on your relationships. So you know, but again, for people that actually do these programs for many of them just that shift to saying, you know what I can't take these anymore it's been years. I haven't gone anywhere. I'm going to invest on myself. I'm going to do something.
Just the fact they do that, also usually they'll start to see a shift in their relationships, just to the fact that they're changing the relationship they first have with them self, which is for the first time in their lives they're actually investing I them self. They are actually taking actions to benefit them self. And that feeling that's when the energy starts to shift and people can feel it in you and not just simply becomes more attractive
TOM: I see. So you have to demonstrate the action the type of person that is in high value that is going after his goals. In other words, you want to be a person that is fun to be around but also has some sense of value.
JAMIE: Yeah. Something inspiring, someone who does things, someone who's investing, someone who's trying to create something, someone who contributes to other people's lives f***ing don't just exist. You're just existing—
TOM: So—
JAMIE: You're still having big dreams then, that's what you don't—that's what you want to not to.
TOM: I guess the real question let me come into this, you are the type of person the first question is what—if you are this type of person, what would be a good way, what's a good example of how you demonstrate high value so we just follow along with the routines or… because this introduces another problem is that if you're always, I spend most of my time improving the handling of this process, educating myself. What then, how do you—what if you don't have the time like all your time is taken up like how was the realistic way to make the time to learn to sell yourself, if you're spending all your time of improving your life? That's my question.
JAMIE: Well, you have to find a happy medium, man.
TOM: Yeah.
JAMIE: Presentation of skills are invaluable, I mean what good is it all of this that you have to offer if you're not 100% yourself in a certain way. So you better find time to learn these presentation skills and stuffs. Dude, how about this: stop reading so many f***ing books and get out there and learn how to—yeah! You get it like so you need to kind of shift some of your time into the kind of thing you and I are speaking of right now. I mean, it doesn't matter how much value you have if you don't know how to communicate that to people. And for the record, Tom, learning how to communicate effectively to people, learning how to really create rapport, these types of skills you and I speaking right now, dating science, this is the ultimate type of personal development.
And I know you've been considering disappearing here, but that would really be a shame because, well I'm just stating the truth. This is the most powerful type of personal development there is because you're not just reading about it, you're just not in the classroom f*** listening. You're doing it and by doing it you can feel for the research and neuro science, you're literally the repetitions in other words be you're interactions to people, the repetitions you're literally rewiring your brain to become a different person; a more assertive individual, a more confident, well-spoken, articulate, clear; that happens with your repetition of doing this. So really, you'll never learn as much in the back of the classroom listening, taking this f***ing seminar, is you're will to the program where a big part of it is actually going to the motions in doing it because it's the repetitions that actually create a rewiring in your brain. Did that make sense?
TOM: Yes. We have that.
JAMIE: That is the truth, it's the doing it. This is like going to the brain gym. You warm up, you do a few sets, but if you push your muscles to a point that they've never been to before, they grow, they respond. You're doing the same thing here but again in the brain gym sort of away. But if you're not pushing yourself and trying new things via your actual actions as well, there is no rewiring, you don't get that benefit. So that's what's phenomenal about this little endeavor. And it winds up spilling off into all areas but yeah what good is all the s*** you're learning if you don't know to communicate it effectively to people? If you want to be the kind of guy, this is what my impression of you is, if you want to be the kind of guy who is able to influence people, to change few, to contribute to teach people, to share. Well, it's kind of like even if you're the most interesting guy in the world but if you're f***ing boring to s***, nobody cares. If you have a DHV—
TOM: Yes.
JAMIE: Story, with a million DHB spikes, but the core of the story is boring as s***, people are going to fall asleep. They're going to excuse themselves and go to the bathroom, it's not going to matter. The core, that story needs to be engaging. Then you throw the DHB spikes. I think it's awesome what you are doing but wouldn't it be a shame that you learn all this incredible stuff and you just don't get the audience that you could have gone if you learn some presentation skills to really improved that so people will want to listen to you.
TOM: Yeah. You made a good point there. So what is the basic ideal lifestyle, if you want to really like say you have an 18-month goal to improve your life, what kind of… is there any good lifestyle or career path or location over the next 18 months to transition too that would allow you to… because I'm a little behind in life and so I have to work on every area.
JAMIE: You are not behind in life that is perception. You are exactly where you should be actually then that's the truth. That doesn't mean to take for granted time that's been afforded to you so we continue onward here like next week, and the month… You're exactly where you need to be. Life went a certain way brought you to a certain point for reasons that you all figure out later. But you're exactly where you're supposed to be. That's not true. But here's something I want to bring to your attention. So you have an 18-month goal, what is your 18-month goal?
TOM: Well, I don't—see that's the problem. I don't know exactly what I want from this other than to say, I think a real 18-month goal is to just change my entire life every area of it and—
JAMIE: Okay.
TOM: I want to learn to be really disciplined but at the same time I want to improve my relationship skills, so I'm not a loner, I guess you could say that have social life, have skills I can get, and have fun so you have a balanced life and not be alone I guess, simple really.
JAMIE: Okay. So let me make sure I have your 18-month goal and tell me if I have these correct. Reaching of goal is to change your entire life, improve your relationship skills, and have fun. Did I summarize that?
TOM: Yes. Basically.
JAMIE: You are laughing because I think you know what's coming up next? What I'm going to tell you, right? Ready? So here we go. This is why you should never drop out of VIP ever. At least if this is something you're truly serious about. So here's the truth because VIP is not just dating sciences, it is a personal development program. Even stuff like this we do a lot of stuff with helping people to goal setting, managing their time, it's an all encompassing personal development program where of course the core is dating sciences type of communication but it's pretty all encompassing, man, so I'm sure some of you here, you don't have a goal. That is not a goal. A goal should be very sensory oriented; it should be quantitative like, these are goals, right? My goal is, I want to have… I'll just give it to you in a business sort of way. I want to have a 2 million dollar business. I want thousands subscribers, I want to be selling this amount to people, I want to be doing two speaking engagements a month; those are goals. Sensory oriented where they can be measured quantitatively. What you just told me is just, that's not a goal. That's—
TOM: Like a—
JAMIE: S***. And—
TOM: Direction.
JAMIE: Yeah, and the secret about that is you're not going to reach your goal if you don't have one and that is not a goal. Your goals need—you need to really go back and make them sensory oriented. Sensory meaning like if we're talking business, I want be doing two speaking engagements a month. I can imagine being in front of a group people and speaking in front of 20 or 30, whatever it is. That's a goal and you have specific sensory details to that goal like I want 30 people from the crowd listening to me. So if we stay with dating sciences and stuff, your goal might be I'm just saying hypothetically, 18 months, I want to be having three dates a week. I want to be able to once a quarter being able to take a girl on a cruise, I want to be able to do that. I want to have three new friends that regularly call me like at least once a week, you know something you want more specifics. Sensory, you would almost imagine these friends calling you up saying, "Hey, Tom. What are you doing this weekend?" Girls… you see what I'm saying here? It is much more clear, it's quantitative, and it's sensory oriented, those are goals. Does that make sense?
TOM: Yeah.
JAMIE: Now, once you do that the most important one for you, probably, let's see how I heard this before. Most people over estimate what they can do in a year, but most people underestimate what they can do in ten years. It's something like that. My point is this is that, you can probably accomplish a lot more than you think you can. So kind of, you know really—
TOM: Let me ask you this. If I only had two days to make the most out of the next two days, how can I make the most out of the next two days of my life to take action to solve this problem?
JAMIE: Okay. That's—now you're on the right track because the next thing I was going to tell you to do is, great! You have your 18-month goal assuming you went back and actually wrote them out. I'd say, okay, what's your goal for the week? Now, I'm going to ask you that real quick. I'm going to spread, I'm going to give you a little more than two days, but what would be your goals for the week?
TOM: Well, I like the sequence setting but I don't know if it is realistic—
JAMIE: Okay.
TOM: For me. So I think maybe to start with like something action oriented like getting out of the house and approaching girls, even though it's just to say hi—
JAMIE: Now you're getting somewhere. Good.
TOM: I would say maybe like two times a week where I go out and get into the zone to approach girls in at least, just go up to 10 girls twice a week. That would be like a goal.
JAMIE: Okay. So—
TOM: Even if I just go out and getting the numbers, because I think the first step is just getting out and setting the habit because I don't—I think I feel I have this specific mentally like I don't have any time so I just need to make, learn to make the time consistently. I think that would be the first step.
JAMIE: That's a b*** s*** thought: you don't have the time. You have as much time as I do, as Bill Gates does, or anyone has, that's the one thing we all have the equal amount off. And then people out there are doing exactly what you're looking to do and they don't have any more time to use that. That a b*** s*** thought, okay?
TOM: I think if there's one thing I can get from this call is how to figure out the mentally and making time in my life.
JAMIE: Okay. So I let that one really quickly. First thing to do as far as making time in your life is look at your day. Don't—stop thinking of it as a big to do list. Think of it in terms of segments on your day, so you might have a segment in your day that everyday is dedicated to dating science, so every day from like say you pick your time. Maybe it's from like five to seven like happy hour time, and that's your dating sciences time. And during that time you can either review your routine stock, you can watch videos but at least two to three times a week you must go out during those two hours. So it's a way of organizing your time so each day there's a segment that is specifically dedicated to this. And no matter what you do it. That's it. Following me?
TOM: So basically two or three times a week you set up segment so you have to go out there—
JAMIE: You need to do something like pretty significant. You can't just ignore the two. You need to really get a real f***ing kick in your ass, man. So with that said, pick something—it's true! Pick something you're going to be doing every day. You don't need to go out and do pick up like actually pick up every day specifically. But you need at least have it in your mind you're doing some work for each day. Either watch a video, you read a book, you go on the form, there needs to be something dedicated to that day because these are telling yourself via actions, this is important.
TOM: Let me go back to the question I had though. If I literally only have, the mentality of this is to take massive action like if you only had two days to solve this problem. Like, forget about the rest of your life.
JAMIE: Yeah. Okay over the two days—
TOM: If you have two days to get the best you can with a woman, what would you do?
JAMIE: Okay.
TOM: Only two days left.
JAMIE: Step one, commit to a time, let's just say your time is from five to seven every day. Even if it's only going to go for two days for the purposes of my conversation to you, five to seven is your time you're using every day, granted it's only for two days, you following me?
TOM: Yeah.
JAMIE: This is something that after two days, in reality you will keep doing it, but it will apply to your two day question. So from five to seven each day is your dating sciences time where you will practice because you will only have two days according to your question, here's what you're going to do for those two days. You got to understand like the best speakers in the world understand that there is a warm up process that is needed. So no matter how good you get at this, Tom, you will need that so we call that get in the state, some kind of a warm up a process so I'm going to give you, I just want you to focus you on warm ups for two days and I will give you several to do and I want you to do all of them, you ready?
TOM: Yeah.
JAMIE: For the two hours I want you to say hi to ten people. You don't have to go any further than that. It can be a guy, it could be a girl, it could be anybody. It's just getting you verbal and also getting you out of your head where you stop thinking it's a big f***ing deal to say hello to people.
TOM: Okay.
JAMIE: You say hi to ten people today, going out your way to do so, you'll have an experience.
TOM: Yeah.
JAMIE: Okay. That's the first one. Secondly I want you to do, and I want you to do all these exercises. Because I want you to have—you have two days, according to what you're telling me here so let's give you as much as you can.
TOM: Yes.
JAMIE: Now have you been watching there, have you been watching the virtual bootcamp?
TOM: Virtual? Well what is the virtual, I didn't know, like understand—
JAMIE: Too bad you're leaving then, we have a virtual boot camp on VIP, where you can actually, over several weeks actually watch the day portion and you still have time to unlock the first lesson now, weeks one and two, so I'd do that and then I'll just tell you what's going to happen here, in weeks one or two you will that there's a couple of routines they start to go through one of which is after you open the next thing comes up your opener is… do you know? You open and then what?
TOM: I open and then you have time constraint?
JAMIE: Cold read. Cold read is—
TOM: How do we do it?
JAMIE: If you don't open you may or may not have a false time constraint. That's a whole another discussion but in general you have some kind of a cold read. For example, the book to gain style, this is opener, hey, who lies more? Men or women? Or is kissing cheating? And they'll respond to him and then I'll say, wait a second, are you guys best friend? That is a cold read. Now in your, in the example you have in the virtual boot camp, the coaches going to use a cold read such as write this down: You know what, you guys just seem like you have really great energy. You got that?
TOM: Yeah.
JAMIE: So, that's going to your cold read. Now your cold read then connects to your A2P's, but what I want you to do because you just have two days here, I want you to go to the virtual boot camp. I want you to kind of go to these A2P's, but I want you to say hi to ten people today, plus with three of them and it doesn't matter whether it's a guy, a girl, a couple. I want you to at least do the cold read to three of those people. So you say hey, how's it going? And then you just kind of almost stop on your tracks and you say, "You know what? You seems like you've really great energy." And again, it doesn't matter who you do it too. I'm trying to give you an experience where you start to really live and understand because through experience, that's not a big deal to say these things to people. In your head it's a big deal, but in reality it's not. Then you start saying to couples and guys and everybody almost like without, not discriminating you realize, this is just a way to be and this, over the two days will help to show you that that it is not that big of a deal. I had a girl the other day—
TOM: Okay.
JAMIE: That asked me why, she kind of challenged me a little bit she's like, why are you coming on pretty strong, you're tell me this things you don't even know if I have a boyfriend yet, and I said to her I said, well I'm actually not hitting on you. I'm seeing if you're worth hitting on. Which is the truth because I don't know what value she has or does not have innately beyond her looks. There's a lot of pretty girls out there, but you and I both know based on what someone says or doesn't say, their attractive can change drastically based on their personality so that was the truth. So what I'm telling here is you'll start to appreciate by doing these exercises that we do this stuff just to realize like some people are not actually as attractive as you thought they we're. And also, when you say these things to people, this is just a way of giving your best selves to people who will be more responsive to you but these lines, if you want to call them that, there is nothing gimmicky about it. It's just a way to help you have the best conversation with people in general, period. Of course you'll have that fork in the road where you maybe decide to take it in a certain direction but that's up to you. But I want you to see from experience that just because you used these lines doesn't men you are doing pick up. It just means you're offering a fun communication with somebody that's it. Okay. So ten highs of the ten, three of them you have to say at least the cold read. You know you guys really seem like you have really great energy. You don't have to go any further than that but you really have to say that, okay?
TOM: Okay.
JAMIE: Also I want you to do two more things, I want you to pick two random people a day and I want you to do the mystery newbie challenge. Do you know what that is?
TOM: No. What's that?
JAMIE: This is were you go to anybody and you can say, hey, did you know that Elvis Presley used to dye his hair? What you think his natural hair color was? Blonde! Isn't that odd? It was nice to meet you and no matter what, no matter how responsive they are you always leave after that. The idea is, you know I'll tell you what. You do the exercise and you tell me what the idea is. But that's the newbie challenge. I want you to that twice a day, too. You can do it to anybody, it doesn't matter. You're going to learn something.
TOM: Hey, could you…
JAMIE: Go ahead.
TOM: Yeah, could you send that to me via email? I didn't catch the whole thing.
JAMIE: I do prefer email me now actually while we're speaking and I'll just respond, I'll just reply back to you, okay?
TOM: Okay.
JAMIE: You do that?
TOM: Well just keep guiding and keep going.
JAMIE: Okay. But do these three things; say hi, you've got two days according to your [00:54:25], say hi to ten people a day, three of them you could do the cold read, you know you guys seem to have really great energy. And again I want you to do that to anybody. It doesn't really matter. I just want you—
TOM: Okay.
JAMIE: To kind of brute force approach and two people a day you do the newbie challenge. Okay?
TOM: Okay. Was there one other thing you wanted to say?
JAMIE: Go and try to use as much of the virtual boot camp as you can.
TOM: Okay.
JAMIE: You report here in two days. That… from that I would not be surprised if you don't feel a little bit more invigorated, reinvigorated. Okay?
TOM: Okay.
JAMIE: By the way, whoever's mic there is on, turn that off because the background is a little distracting.
ZACH: Okay, yeah. Whenever you're done with this other guy, I have a couple of questions?
JAMIE: Okay. All right! Awesome!
ZACH: Just quick ones.
JAMIE: Beautiful.
ZACH: Just let me know.
JAMIE: You got it! Give me about 30 seconds, will be right with you. So there you go. You got your two day boot camp but the other thing I want you to do, the last thing, number five, Tom, is I want you to write down goals for the week and for the month and real goals, quant it. They should be able to measure them quantitatively and they should have—they should be sensory detailed. It should be something really clear about them. Three dates a week. Going to these kinds of places, real clear goals, do it for a week and month, okay?
TOM: Okay.
JAMIE: Just do all those stuff and you might be surprised you might have a little momentum behind you. Okay?
TOM: I have like one or two more questions but I don't…
JAMIE: Yeah, that's… I got to cut you off here.
TOM: Okay.
JAMIE: But look, you got a lot to work with. Do those things; send me an email, happy to send you that exercise verbatim. That alone is going to push you forward.
TOM: Yes.
JAMIE: And then you want to write these couple of questions in the email, just do that as well. And I would really—
TOM: Okay.
JAMIE: I would really reconsider disappearing because it's a shame. You've not taken advantage of this the whole way through. This is what you are missing and again, it kind of sucks to get all these, learn all these things and have no one really listening.
TOM: Yes.
JAMIE: So think about that, okay?
TOM: Okay.
JAMIE: All right, man. Good speaking to you, Tom.
TOM: Yeah.
JAMIE: All right! Zach, you there?
ZACH: Yeah. How are you doing, man?
JAMIE: Good, man.
ZACH: Cool. Yeah, just a couple of questions. This is my first call. So—
JAMIE: Yeah.
ZACH: Yeah, when we have these calls do I just hop on and ask a question or is it supposed to be like email you with my question and then we go over it during the meeting? Is that how it works?
JAMIE: No, you just do it live on a call, you don't have to email it to me. Yeah, on the call the ideas you come on to with an interaction from the previous week or two, and we then basically help you to come up with some next steps and insights and ways to improve for the next time.
ZACH: Okay. Cool. Yeah, then—
JAMIE: Yeah. It's really in a group sessions like a sticking point session, that's the core of the calls. So yeah, the idea is every week you are doing your minimal 15 sets and of course if you really do your 15, you're going to have at least one that doesn't work out that well. So we kind of, you know, we talked it during the call and we give you some insights on what can we improved upon. In addition to that, you can have other kind of more personal development oriented questions because we want it to be an own conversing program just like when we reached out to Tom, you knew he was asking stuff about goal setting and things of that sorts. So that's all fair game, too. But yeah, you just come into the call and do whatever you want to talk about.
ZACH: Really? Cool. Yeah, that's it. Yeah just one more thing. So I'm going out tonight. I got that first opener that you're totally distracting me. The direct one.
JAMIE: Mm-hm.
ZACH: So what's like one like the direct one if I'm doing like these mixed sets or something?
JAMIE: You can do the same thing with them, too. Just present as a group. Hey, you guys are totally distracting us. It's the same thing you just make up girl.
ZACH: Even if there are dudes in there? Wouldn't it be like weird?
JAMIE: I mean, look. You can get away with anything if your frame is strong enough. In that case personally, I have two direct openers that I'll use and if it's guys like that, the one I preferably use would be: hey, I just want to come over and say hello. You guys just seem like you've really great energy.
ZACH: Okay.
JAMIE: That's what I'll use.
ZACH: So do you not use indirect at all?
JAMIE: I do use indirect.
ZACH: Okay.
JAMIE: Again, the more you kind of like go down this path you're going to se that they're, they both have value just depends on the situation.
ZACH: Okay. What's one like good indirect opener that I can use myself and practice indirect opener, you know?
JAMIE: If you want a good indirect opener just to start with you can use the classic opinion opener if you wanted to. Hey guys, my friend—
ZACH: Ah, okay.
JAMIE: Yeah. Just use the opinion opener. Hey, my friends and I were just talking about this, is kissing cheating? You can do that one for example if you wanted to try that.
ZACH: Okay.
JAMIE: You can try one of those. I will tell you my own personal experience. I like direct the best. Like usually what I do… because I understand when you go direct or indirect, it's just the opener. Regardless of how you start eventually you are going to have to ask for what you want. So you can't, you're going to go direct to a certain point because [Background crosstalk 01:00:06] I personally like direct the best because, what's really going to make your delivery amazing potentially, if the people can tell you are good congruent for it. And if the truth is you want to speak to them, there's something about them and you verbalized that clearly, they're just going to, it's just going to be congruent presentation, like this guys clearly is what you see is what you get, you know.
But I want to be clear on this one, just because you were going direct, doesn't mean you're showing your hand. You can absolutely go direct and not necessarily be all goo-gooly eyed over them. Like I'll give you an example, let's just say you are at like a sports bar and you saw a group of girls, let's just say these girls—for the sake of saying, let's just say they were five's and six's because they were kind of cute at best. But they're having fun, they're playful, they have great energy. Maybe you genuinely like people and you just want to talk to them for the sake of doing so, which is obviously my hope for you, too, Zach. Like we want you to use this as a sociable tool, networking tool. Something you use way beyond just pick up or dating sciences, but, anyways, staying on my example let's just say this group of girls, so there's more than one and they are kind of cute: five's and six's, and they're doing rounds of shots, and they have great time and we're at a sports bar so they are wearing a bunch of university of whatever paraphernalia.
So you meet your friends, you could definitely go over and say, hey, you guys are totally distracting us. I don't know if it's the head to toe university of Michigan here or your enthusiasm for shots, what is this, round number five? Anyway, I just want to come over and say hello. I'm genius [01:02:03] In the context I'm giving you, does it sound like I'm hitting on them or does it sound like I'm being sociable?
ZACH: Okay, I got you. So then after that you're going to like best friends test or something?
JAMIE: You could do that. Once they response to you, you say, "Wait a second, are you guys best friends?" You absolutely can do that. But I want to be clear on this one, you're going to have more of a potential to do the best friends test off the opinion opener because the opinion opener you're asking for their opinion. They'll oftentimes; the girls will look at each other or will discuss it, so kind of get in… "No, of course it's cheating." "No, it's not." "Yes, it is!" And in the midst of that, you could translate the responses or quoting each other or moping each other for some kind of reassurance that's going to be easier to part with the best friends test to offer something while they're interacting with each other. You following me?
ZACH: Yeah, that's it.
JAMIE: They'll look at each other it's going to be harder to parlay that, wait a second, are you guys best friends? You keep making the same facial expressions, but they're not really engaged, they're just looking at you. So it won't—
ZACH: So what?
JAMIE: Here.
ZACH: Yeah, I got this. So what would you use then in that situation you just described for to transition the introduction?
JAMIE: Use the same cold read that I was talking a second ago which is, "You know, guys, you seem like you've really energy."
ZACH: Oh, okay. So like that's… okay, I got that. So like how do you transition and introduce yourself, how do you get into like actual conversation after that?
JAMIE: Okay. So you open, you do your cold read, "You know you guys just seem like you've really great energy." Pause for a second. You have like this West Coast vibe, or East Coast vibe, or Mid West vibe, you pick one.
ZACH: Oh, I see.
JAMIE: Then what's going to happen Zach is, they're going to agree or deny. Yeah, we are actually from New York, or we are not from Florida, we're actually from New York or we're from—they're going to tell you and then based on that, then you would stack forward to your first little mini DHV stories. So for example, let's just say you said, you know you guys have like this Mid West vibe, and they said actually were from New York.
ZACH: Yeah.
JAMIE: When they say that, you are going to then start for the story like, oh, my god! Check this. Get this. And you'll tell a story that has some kind of New York theme to it. Some kind of mini DHV story. But the story that you actually lived, what's really key to the stuff, is that these are your stories that are what allows you to deliver in a powerful congruent way. So you would tell a story, a DHV story, in other words that humorous entertaining story with DHV spikes.
ZACH: Okay, but first I'm sure that you guys stories, right? Because what you're saying on the other call that…
JAMIE: Yeah. I mean first… the way to go to the virtual boot camp, the way it's kind of presented there is we'll do like an indirect opener for you or opinion opener and then from there it would then stack forward to like the best friends test or something like that so, yeah—
ZACH: Yeah. Good.
JAMIE: You would improve in the beginning just for the sake of practicing.
ZACH: Okay. So like for tonight I shouldn't be using really direct openers. I should stick to that. Something like to prep myself at the boot camp, so when I hit the boot camp I'm like hit the ground running, you know what I mean? And I end like learn everything I just need tweaking.
JAMIE: Yeah.
ZACH: You know what I mean?
JAMIE: Yeah.
ZACH: So like should I— at bootcamp.
JAMIE: What I'd do for now is do the exact that is given to you at the virtual boot camp of the VIP because it's done for you there, and you just follow the sequence.
ZACH: Okay. Is there any way you can give me like access to little more than the first two weeks because I think that's just opening, so I was not just going to go for an opener it's like nothing to go off of.
JAMIE: Yeah, I don't really have mechanism for doing that.
ZACH: Or do you have like a big list of routines or a beginner routine stack that like, oh, here's a good one that I can start off with or something?
JAMIE: I don't know, we'll actually for the sake of saying then, all those—there's a ton of stuff if you just go through the actual, the main core VIP which is the time line of the interaction. So you have section for openers, transitions, you have all that stuff there. See you have that there as well. And that's all stack–
ZACH: Okay.
JAMIE: That's all stack stuff.
ZACH: Got you. I know.
JAMIE: I hope you're there didn't pull apart what resonates for you. You see part of it makes a little bit of a process is just because we give you something you might not like that scenario this is what resonates me we'll try this instead, so best advice to start, I mean thing that you just thought about tonight, I mean it's not the end old man. If time works out great if not, whatever. At least it'll be the most important thing is what you're doing which is you have a goal, you're going to go out there you're going to be the best you can with what you got. They have some [inaudible] to start with, in the time line of attraction, the main center piece of VIP. So hope you would go there and see what you see that you want to try.
ZACH: Okay.
JAMIE: Okay.


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Posted 18 October 2017 | By Michael Mezher
While recent reports have claimed that drugmakers are manipulating the incentives provided by the Orphan Drug Act, Mike Lanthier, an operations research analyst at the US Food and Drug Administration (FDA), says that in most cases, the act is working as intended.
"My sense is that the Orphan Drug Act has been a successful catalyst for spurring rare disease development," Lanthier said at the National Organization for Rare Disorders' (NORD) Summit in Washington, DC on Tuesday.
Congress passed the Orphan Drug Act in 1983 to incentivize the development of drugs to treat rare diseases by offering drugmakers tax credits, fee waivers and a seven-year period of marketing exclusivity for an approved orphan indication. To qualify for orphan drug designation, a product must be intended to treat a disease that affects fewer than 200,000 people in the US, or more than 200,000 if the drugmaker can show that it is not expected to recoup its costs to develop and market the drug.
Critics of the act claim it has allowed drugmakers to charge exorbitant prices for many orphan drugs and argue that drugmakers have taken advantage of its incentives by repurposing existing drugs to treat rare diseases or getting approval of a drug in multiple subtypes of a disease, a practice known as salami-slicing.
According to FDA, only 10 treatments for rare diseases were developed in the decade leading up to the Orphan Drug Act. Another estimate finds that 34 drugs that would have qualified for orphan drug designation were approved between 1967 and 1983.
Between 1983 and 2016, FDA approved 451 orphan drugs for 590 rare disease indications. It is estimated that there are some 7,000 rare diseases, most of which have no approved treatments.
According to Lanthier, the vast majority of those drugs (374, 83%) were initially approved for orphan indications and only 12% were first approved to treat a common condition before being approved for an orphan indication.
Lanthier then said he wanted to find out whether companies are "getting orphan approval at the outset … just to get their foot in the door to add non-rare indications later on."
Based on his analysis, three quarters of the 374 drugs that were first approved as orphan products were never approved for an additional indication. Another 11% were approved for additional indications within the same disease as the initial approval, such as the addition of a pediatric indication.
Only 8% of the drugs were approved for indications in other rare diseases and only 7% were later expanded for use in a non-orphan indication.
"Most drugs that encounter the Orphan Drug Act start out as a rare disease treatment and throughout their marketing history actually remain rare disease treatments," Lanthier said.
He also addressed the fact that many of the top-selling drugs on the market have been approved for orphan indications.
"One of the things that's been pointed out by people is that there are a lot of high revenue drugs on the market—some of the top selling drugs—have at least one orphan indication approved," Lanthier said.
To examine the issue more closely, Lanthier looked at the 20 top selling drugs of 2016 based on data from QuintilesIMS. While eight of those drugs had at least one orphan indication, only three were approved first as orphan drugs before being expanded to a more common indication.
Lanthier also said that these top-selling drugs are somewhat atypical with regard to how many indications they've been approved for, as six of the eight drugs had between 6 and 15 approved indications. Of the remaining two drugs, Copaxone (glatiramer acetate) was only approved for a single indication and Neulasta (pegfilgrastim) was approved for a single orphan indication following its initial approval.
"The sheer number of indications approved in these products is unusual, they've expanded their indications in multiple ways, including multiple indications for non-rare indications, which probably accounts for a lot of the revenue that's being generated by these drugs," Lanthier said.
He also pointed to the number of orphan products qualifying for FDA's expedited review programs as evidence that orphan drugs often have the potential to bring a meaningful benefit to patients.
"The high proportion of these approvals that are qualifying for FDA's priority review and breakthrough therapy designation suggests a need or potential of orphan drugs to have a positive impact on the rare diseases they treat," Lanthier said.
Tags: Orphan Drugs, Orphan Drug Act
Categories: Regulatory News
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In this page: FDI in Figures | Why You Should Choose to Invest in Iran | Procedures Relative to Foreign Investment | Investment Opportunities
In a context where global foreign investment increased by 10.9% in 2013, in particular in Europe (+25.2%) and in Latin America (+17.5%), FDI flows to developing economies reached a new high of US$759 billion. However macroeconomic fragility and policy uncertainties are driving investors to caution.
The flows of foreign investment in Iran remain very weak compared to the enormous potential that the country can offer. This is due to several factors: the state's supremacy in the economy, external political risk (American embargo, economic sanctions, nuclear issue) as well as internal (impoverishment of the population, social risks, inflation, crisis of the political regime), and heavy bureaucracy in all sectors.
Foreign investment was developed a little during the era of Khatami who offered an international opening to many foreign companies, notably French and Italian, which invested in oil and gas projects. However, the rate of investment in the country remains very associated to the political context and despite the current detente, it is very difficult to predict the global situation of Iran in the next following years.
The Geneva agreement, signed in 2013, has brought relief to a national economy asphyxiated by the sanctions and removed some obstacles to the FDI influx, already pushed by Chinese and Russian investment, particularly in the natural gas sector. In 2013 FDI reached USD 4.8 billion.
Information on the 2013 FDI influx in this region can be accessed in the Global Investment Trade Monitor published in January 2014 by the United Nations Conference on Trade and Development (UNCTAD).
|Foreign Direct Investment
|FDI Inward Flow (million USD)
|FDI Stock (million USD)
|Performance Index*, Ranking on 181 Economies
|Potential Index**, Ranking on 177 Economies
|Number of Greenfield Investments***
|FDI Inwards (in % of GFCF****)
|FDI Stock (in % of GDP)
Source: UNCTAD - Last Available Data.
Note: * The UNCTAD Inward FDI Performance Index is Based on a Ratio of the Country's Share in Global FDI Inflows and its Share in Global GDP. ** The UNCTAD Inward FDI Potential Index is Based on 12 Economic and Structural Variables Such as GDP, Foreign Trade, FDI, Infrastructures, Energy Use, R&D, Education, Country Risk. *** Green Field Investments Are a Form of Foreign Direct Investment Where a Parent Company Starts a New Venture in a Foreign Country By Constructing New Operational Facilities From the Ground Up. **** Gross Fixed Capital Formation (GFCF) Measures the Value of Additions to Fixed Assets Purchased By Business, Government and Households Less Disposals of Fixed Assets Sold Off or Scrapped.
Iran represents an important market (70 million inhabitants) with a young population eager of consuming foreign products. It is a solvent market with an enormous need of consumer goods, equipment and large infrastructure projects (electricity, water, accommodations, transport, etc). Production costs (work, energy, etc) are low.
Iran, because of its geographical location, is also an ideal base for exports in the region and its energy resources are very attractive to foreign investment.
The influence of the State in the economy is very important with numerous organizations linked to the state and disposing of funds and important budgets without coherent management. Corruption is wide-spread in the country.
Geopolitical tensions, particularly with Israel and domestic instability are also major risk elements.
In order to attract foreign investment as well as obtaining knowledge, buy-back systems have been established in which the revenues of the foreign investor partner can be repatriated in the means of goods and services produced by the project. In terms of investment, the Iranians offer privileges to investors who can provide long term strategies and transfer of technologies.
Learn more about Foreign Investment in Iran on Globaltrade.net, the Directory for International Trade Service Providers.
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Learn more about Investing in Iran on Globaltrade.net, the Directory for International Trade Service Providers.
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Last Updates: October 2014


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Since the beginning of time, there has been no image more revered than that of a mother with her child. Just take a good look around all the famous museums in Europe and churches throughout the world. The image of the Madonna with her newborn evokes amazing feelings of warmth and unconditional love in most of us. Men actually bow down in the presence of such beauty. Why? Because our ability to give birth is a powerful one, and it is one of the few gifts that man will never truly be able to understand or experience.
Sadly, at the same time that we are given such power, we also become the most vulnerable in our lives. These vulnerabilities are exploited blatantly at times, especially in the workforce, and then more subtlety often times, at home. We make so many sacrifices for our children and the desire to provide them with a beautiful home, good schools, stimulating activities and a fighting chance at a promising future. In the pursuit of their best interest, we may even try to suppress our own needs or desires, and this is where we really have to be careful because if we sacrifice too much of ourselves, we expose ourselves to true danger-- sometimes internal, but more often than not external.
There are predators lurking everywhere, and while some are easy to spot, others are not. Beware of the wolf in sheep's clothing is a mantra all women need to embrace, especially in this day and age. Always keep your guard up and question people's motives-- not that I want to promote paranoia, but I say this because of everything I have seen and experienced both personally and through the lives of so many others that have needed my help as a divorce attorney over the last 15 years.
Those who know me think of me as the eternal optimist, and indeed I do my best to focus on all the positive things in life. But let's be real-- I hear heart-breaking stories every day. It is my job to run damage control on a daily basis when love stories go awry. While I do my best to surround myself with positive energy, I cannot ignore the fact that there are negative forces out there as well. We all know that opposites attract-- but only over time will you be able to assess whether this dichotomy provides you with good balance. If those scales grossly tip to one side, and is obvious that the good does not outweigh the bad, you need to be prepared to bail, and to do it fast.
Positive people are super attractive, and now especially if you are a MILF (not that I'm okay with that term, but I accept it's becoming part of our normal vernacular) the key thing to remember is that you are above all a MOTHER. You have a young one that needs you to survive, and it is therefore your primary job to protect your own cub, but you can't do that if you don't protect yourself. Therefore, always maintain your own credit, have your own bank accounts, make sure you know your legal rights, and have an emotional safety net. Don't ever let yourself become so dependant on someone that you can't fend for yourself.
Being brutally honest, the last eight years as a single mom have definitely been full of difficult challenges, but I've also had a lot of fun. Navigating the dating world in my post-divorce years has given me great insight into the male mind. Yet while soaking up some of the best compliments in the world, I've continued to build my fortress of steel to fend off serious dangers- why? Because it is not just about me anymore, and that is the point I want my fellow single moms to embrace. I'm not suggesting you swear off all men-- just proceed with caution.
In the end, I will always remain grateful to all my exs that treated me like a queen, and I continue to cherish all the great nicknames, including "MILF, doll, babe, beautiful, sexy," and even "princess." But, the best compliment of all came from my son the other day. He reminded me that it is the female lion that hunts and provides food for her family, and then he said, "Mom, you are a great hunter." Well, I am trying... Here's hoping all other single moms out there find that female lion that lives within all of us!


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On November 18, 1996, the Czech Philharmonic Orchestra returned to Kennedy Center.
During the hundred years of its existence, this orchestra has developed its own
performance style, based on the Prague tradition of interpretation which developed along
with the international music repertory from the Middle Ages to the present day. In this
tradition, all that one experiences in life and art finds expression in music. An
interpretation thus conveys not only the composer's subjectivity, but the understanding of
all who have meditated upon and performed the work at hand, and shows its relationship
to the repertory as a whole. During the difficult times of Nazi occupation and Communism,
the tradition became a psychological refuge, a means of defining a better world, and
musical interpretations gained depth and significance. The orchestra can now take
advantage of the cumulative achievements of these years, while giving the works of the
Czech orchestral repertory a new, more unrestrained voice.
The orchestra reaffirmed its tradition in the first work of the program, the movement "From Bohemian Woods and Fields" from Smetana's Ma vlast. This work is often interpreted as a simple depiction of nature; however, this performance revealed that it has much more significance. The execution was flawless; every timbre, nuance, and melodic line was not only exactly as it should be, but had purpose and direction, even a sense of adventure. It would have been most interesting to hear the entire cycle.
The soloist in Mendelssohn's Violin Concerto was Alyssa Park. Her sound is delicate, but has resilient strength and an unforced, free virtuosity. Her interpretation was the very personal one of a young woman taking delight in the world, and the orchestra responded sensitively to it. The work was played with the sympathetic understanding and attention to detail which one takes for granted in performances of chamber music, but is rare in orchestral concerts. For example, the woodwind accompaniment to the first theme of the last movement, which is often underrehearsed, was not only executed precisely, but was an integral part of the interpretation itself and a pleasure to hear.
The strength of the orchestra's performance tradition was most evident in Dvorak's Symphony no. 8 in G major. The clarity of the interpretation gave the work unusual comprehensibility. For example, the formal structure was immediately understandable, but did not interfere with the intuitive flow which enables the work to find its coherence in sound itself. The interpretation appropriately conveyed a diverse range of emotions and expression, rather than the raw passion often found in performances of late Romantic music. In the midst of it all, there was a brief, tantalizing hint that the orchestra would have played Mahler with equal success.
The orchestra then had a bit of fun giving bravura interpretations of the encores: the sixteenth and fifteenth Slavonic Dances by Dvorak, and Fucik's Entry of the Gladiators, beloved in America as the quintessential circus march.
The orchestra has recently gained an excellent new conductor, Vladimir Valek, a musician with intelligence and heart -- and a flair for showmanship -- who fortunately seems quite able to carry on its irreplaceable tradition. (Judith Fiehler).
"Czech the News" - Newsletter of the Embassy of the Czech Republic, Washington DC.


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When the field takes the green flag this Sunday for the FedEx 400 Benefiting Autism Speaks at Dover, the driver of the number 11 FedEx car, Virginia native Denny Hamlin, will be leading the way after qualifying on pole with a time of 22.788. This is the second straight week that Hamlin has qualified on pole. Continue reading
Monthly Archives: May 2013
Pierre Garçon says shoulder's fine, not sure about foot
RG3 focusing on studying more while knee recovers
Heat Pull To Within One Win of NBA Finals
Behind a stellar 30 point, eight rebound, and six assist night from LeBron James, the Miami Heat are now just one win away from earning a spot in the NBA Finals against the San Antonio Spurs after defeating the Pacers 90-79. Continue reading
Summer Reading: A Father First: How My Life Became Bigger Than Basketball
Through the spring months of 2013, my book of choice was Michael Vicks Finally Free. For the summer, or at least the beginning of it, my sports book of choice belongs to Dwayne Wade. Continue reading
Philly QB Trusts His Speed Over RG3's
Do I see a charity football track meet in the near future?!
Nats (Finally) Find Some Offense
Last night at Nats Park fans got to see two things that they haven't seen all year, starting pitcher Nathan Karns and the Washington Nationals offense.


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|Traditional green bean casserole served as a holiday side dish.
Well, I lost the recipe.
But, while foraging the pantry and the freezer for a quick supper, determined to "use what I have," I tried to recreate it from memory. The result was quite tasty.
Green bean casserole is traditionally a holiday side dish with little protein. This version can be enjoyed throughout the year and gets a protein boost from the soy crumbles (the original recipe called for turkey or beef.)
This recipe is vegetarian, but not vegan, because the cream of mushroom soup contains dairy.
I call this Cherie's "Slop-it-Together Supper." Enjoy. Serves six.
1 (12 oz.) package Morning Star Farms Meal Starter soy crumbles
1 cup cooked white or brown rice
2 (15 oz.) cans French-cut green beans, drained and rinsed
2 (10 oz.) cans Campbell's Cream of Mushroom soup, undiluted
2 cups French-fried onions, divided
Preheat oven to 350 degrees Fahrenheit.
Prepare rice according to package directions and measure (a little extra is OK.) Prepare soy crumbles according to package directions until fully cooked. Drain and rinse green beans.
In a large bowl, combine soy crumbles, rice, green beans, soup and one cup of the onions.
Transfer to a two-quart casserole dish greased with vegetable shortening or sprayed with non-stick cooking spray. Cover and bake for 30 minutes, or until bubbly around the edges.
Remove top and sprinkle with remaining onions. Continue baking, uncovered, for five minutes or until top is brown.
Serve with a fresh fruit salad.


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Using standard equipment, Sureshield works with most modern coating application equipment and processes. When applying Sureshield, follow the directions of the application guide and apply in a controlled environment. For best results, be sure to clean all equipment prior to use.