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  1. #11
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    Quote Originally Posted by hellouser View Post
    If the FDA stalls them I will have a psychotic burst of fury and will be out to destroy the FDA.
    Hell-riser then?

  2. #12
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    hellouser I'm definitely down for that....

    and Desmond, histogen should be out before Q4 2015 for sure in Asia.. Ziering said 2-3 years for Asia release!

  3. #13
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    Quote Originally Posted by hellouser View Post
    I've done these kinds of movements before and was even contacted by NDP leader Jack Layton. I'm really disappointed that there arent more people willing to join but if anyone wants, please let me know.
    I miss Layton. He could have used Aderans big time.

    I'm interested in helping you out.

  4. #14
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    Quote Originally Posted by Desmond84 View Post
    Unfortunately, Aderans has fallen behind by around 12 months from their original timeline. If you look closely at the timeline, they were planning on finishing Phase 2 by June 2012 and Start Phase 3 around 4 months after.

    Phase 2 however is going to finish on April 2013 and they need another 3-4 months to collect data and apply for Phase 3 trial.
    No, they have many different trials going on in Phase 2 stages, some finished last year while one more started last year. Their last Phase 2 trial started in October 2012 which is a 6 month trial, however that one as you pointed out will be done by around April or sooner of this year. However, the others which have already finished Phase 2 should be able to start Phase 3 soon after. Even if Phase 3 takes 18 months we'd still be looking at 2014 release date. However none of us are sure what the FDA will do to the approval process which is why I'm so goddamn angry already about this and disappointed at the lack of enthusiasm from others on this forum to take action and claim whats ours.

    I guarantee you, the amount of thought and stress I cant shake off from my hair loss would deem me clinically depressed. Its on my mind on a daily f*cking basis. I want my life back and I won't let the FDA screw me from any more years of torture; I'm depressed, I lack enthusiasm, I'm afraid of being in social groups, I'm constantly worried about my thinning hair, I look significantly worse than what I did just 5 years ago, my confidence is at an all-time low, I have very low self-esteem, I often times avoid meeting women (did that even on my own birthday, was supposed to have dinner with a girl I dated before and blew her off since I was so depressed BECAUSE of my hair loss), etc. etc. The list goes on. And now that we're this close people just seem so damn passive about taking action against the FDA? Why? Why is it that people care so little for something they could ultimately have so much control over? Aren't all of us on this forum because we have similar problems to mine or maybe even at higher levels (but hopefully not)? I never understood this. I got the same feeling with Canadians when I rallied alongside Jack Layton: PEOPLE JUST DONT SEEM TO CARE. WHY?

    Considering Phase 3 will take 18 months + 10 months FDA approval, Aderans should be available by Q4 2015!
    Quote Originally Posted by Desmond84 View Post
    Considering Phase 3 will take 18 months + 10 months FDA approval, Aderans should be available by Q4 2015!
    I'm getting a lot of conflicting information from many different people on the matter of Phase 3 and FDA Approval;
    • Youre saying basically 28 months for Phase 3 and FDA approval which is 2 years and 4 months in total.
    • Aderans themselves pointed out an immediate release of their product after Phase 3 so 2014 would still be possible with an immediate release after Phase 3 next year.
    • Another member on this forum who's a pharmacist made claim FDA approvals can be submitted during Phase 3 trials.
    • When I spoke to an Aderan's rep over the phone a year ago they said FDA approvals require 4 years of extra data after Phase 3.
    • My closest friend who's a chemist said that if they finish their Phase 3 trials they'll get their approval no problem especially considering its your own cells.

    So, who's got the right info? I'm leaning towards the 2014 date, not because of my optimism or hope, but for a few things; the pharmacist here on BTT, my chemist friend and Aderans themselves projecting that date. Why the latter? Because if they delay the date so much as another 2 years (approximately according to your numbers) this will really piss off all of their investors. Theyre in this to make money which is a far more powerful force than feeling empathy for someones misfortunes (sad but true, human race is a disgusting plague with little to no integrity or dignity).

    If you think about it though, it's way ahead of any other upcoming treatment and isn't that far at all.

    Also, with regards to the treatment being safe since it is your own cells (Autologous), FDA already got taken to court about that, but they won the court case, since Aderans and other autologous therapies add growth factors to multiply your cells which are not yours and can introduce complications. So, the court ruled that all 3 phases must be concluded before a company can file for FDA approval! sad but true!
    Not necessarily, Washenik stated they have a number of different delivery methods of their product and will in the end chose the best one. The poorest methods will obviously get scrapped so it doesnt make sense to wait for the others to finish to start separate trials.

  5. #15
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    Hellouser

    What do expect people to do in terms of rallying to the FDA? I mean, how are you expecting people to help?

    I am UK based but will help if I can with any online stuff...

  6. #16
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    Quote Originally Posted by garethbale View Post
    Hellouser

    What do expect people to do in terms of rallying to the FDA? I mean, how are you expecting people to help?

    I am UK based but will help if I can with any online stuff...
    Theres a lot that can be done. A lot.

    I've address this before in another thread but I'll copy/paste my initiative here. In order to speed up the process and get the product out the door we need to:

    Get in touch with local, provincial/state tv news, radio, local and national newspapers, bloggers (yes, even them), get spencer to spread the word through his own connections, run campaigns via facebook, twitter, setup a website and keep it active, create videos sharing life struggles, depression, anxiety, stress, etc..... tell a story people can connect with, reach out to politicians who have other connections, organize an actual outdoor rally RIGHT IN FRONT of the FDA's head office, leave handouts, get physical signed petitions (e-petitions are worthless)... etc. etc. etc.

    Its not a 'one route' rally.... you basically have to cover all areas and gain the media's attention and for them to spread the publicity. If its done right, it could go national or even international. Think of how many stupid internet campaigns exist... like the kids who asked for 1million like on Facebook to get a PS3 because their mom promised them, stupid shit like that.

    I work in graphic design, marketing and web development, I'm basically the go-to guy for anything creative at my current job, which is why I also know photography quite well as I've explained before the difficulties in getting consistent photographs from Aderans/Histogen showing their results. I'm more than willing to get the ball rolling on an awareness campaign and get the FDA to give Aderans the green light soon after Phase III next year but ONLY if there are others who are willing to put in the time doing this. Otherwise, I'll be a one man team.

    Basically we'd need to start off with a name, logo and mission statement. Then gather information, content, video etc. Make a website, put everything together. Then make facebook & twitter accounts to tap into social media. Then you need to make the right phone calls to the right people. I rallied 2 years ago alongside Jack Layton but it was only possible when me and my friends made enough phone calls and got on the news that he noticed us.. we partnered with other non-profit organizations and made a collaborative effort. The result? The government heard us and we won the battle (cant say which cuz it'd reveal my identity, lol). Its not hard work, its just tedious stuff that requires a lot of strategy and planning.

    If anyone wants to go through with this, I can start a new thread and see what we can do as a community and get our hair back ON TIME from Aderans without the FDA screwing us over.

    This post basically got ignored in the other threads but I am 100% committed to this and helping myself and everyone else in the process. I want my hair back just as anyone else here and am willing to fight for it.

  7. #17
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    Quote Originally Posted by hellouser View Post
    Theres a lot that can be done. A lot.

    I've address this before in another thread but I'll copy/paste my initiative here. In order to speed up the process and get the product out the door we need to:

    Get in touch with local, provincial/state tv news, radio, local and national newspapers, bloggers (yes, even them), get spencer to spread the word through his own connections, run campaigns via facebook, twitter, setup a website and keep it active, create videos sharing life struggles, depression, anxiety, stress, etc..... tell a story people can connect with, reach out to politicians who have other connections, organize an actual outdoor rally RIGHT IN FRONT of the FDA's head office, leave handouts, get physical signed petitions (e-petitions are worthless)... etc. etc. etc.

    Its not a 'one route' rally.... you basically have to cover all areas and gain the media's attention and for them to spread the publicity. If its done right, it could go national or even international. Think of how many stupid internet campaigns exist... like the kids who asked for 1million like on Facebook to get a PS3 because their mom promised them, stupid shit like that.

    I work in graphic design, marketing and web development, I'm basically the go-to guy for anything creative at my current job, which is why I also know photography quite well as I've explained before the difficulties in getting consistent photographs from Aderans/Histogen showing their results. I'm more than willing to get the ball rolling on an awareness campaign and get the FDA to give Aderans the green light soon after Phase III next year but ONLY if there are others who are willing to put in the time doing this. Otherwise, I'll be a one man team.

    Basically we'd need to start off with a name, logo and mission statement. Then gather information, content, video etc. Make a website, put everything together. Then make facebook & twitter accounts to tap into social media. Then you need to make the right phone calls to the right people. I rallied 2 years ago alongside Jack Layton but it was only possible when me and my friends made enough phone calls and got on the news that he noticed us.. we partnered with other non-profit organizations and made a collaborative effort. The result? The government heard us and we won the battle (cant say which cuz it'd reveal my identity, lol). Its not hard work, its just tedious stuff that requires a lot of strategy and planning.

    If anyone wants to go through with this, I can start a new thread and see what we can do as a community and get our hair back ON TIME from Aderans without the FDA screwing us over.

    This post basically got ignored in the other threads but I am 100% committed to this and helping myself and everyone else in the process. I want my hair back just as anyone else here and am willing to fight for it.


    100% with you my dude!


    btw Histogen should be end of 2014, end of 2015 at the latest in Asia! According to Dr. Ziering

  8. #18
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    Quote Originally Posted by FearTheLoss View Post
    100% with you my dude!


    btw Histogen should be end of 2014, end of 2015 at the latest in Asia! According to Dr. Ziering
    I'll start thinking of some names for the campaign, going to have to use my copywriting skills to their maximum efforts as its one of my somewhat weaker skillsets (logo design is by far my worst)... which is too bad because the two are needed for the foundation of a brand identity!

  9. #19
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    Gail Naughton did an interview near the end of last year and stated that HSC could be expected in the US by 2016 and possibly a year before in Asia. I posted the video a few weeks back. In the interview she said FDA will require 4 trials so I'm guessing that would be phase I, IIa, IIb & the phase III. I wonder therefore if Histogen expect Asian authorities to allow it after phase IIb hence why Asia could 'possibly' have it a year before US.

    I don't mean to be negative but do you really think you can push the FDA into fast tracking Aderans? I wish we could but it just seems so unrealistic. They're a government agency and they have set guidelines. Also if Spencer could do anything through his contacts do you not think he'd be doing it already?

  10. #20
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    Quote Originally Posted by UK Boy View Post
    I don't mean to be negative but do you really think you can push the FDA into fast tracking Aderans? I wish we could but it just seems so unrealistic. They're a government agency and they have set guidelines. Also if Spencer could do anything through his contacts do you not think he'd be doing it already?
    Yes, its possible. Certain meds got fast tracked in the 90s for AIDS. Now, I know hair loss isn't a life threatening issue like AIDS but it is definitely possible. Still, by 2014 the FDA will have 12 years of data from Aderans. Far more than enough data to give the green light.

    I don't think Spencer has done much about spreading the word and getting in touch with contacts. Personally, I don't see him being the type of guy to push a movement like this forward. Regardless of my opinion of him, its still to early to do that, I think we'll need to wait for the next press release from Aderans in regards to their Phase III trials and then see whats going on. Once we know where they stand on timeline's we'd then have a better idea of how to launch and organize such a movement in regards to Aderan's own dates.

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