Histogen and Aderans

[FearTheLoss]

There seems to be a lot of confusion on when these treatments are supposed to make it to the market.


Can someone, WHO KNOWS FOR SURE, clear up when each of these should be released..

Thank you

[FearTheLoss]

Histogen:

2-3 years in Asia, somewhere around 5 for the United States

Also, possibility of combining phase II/III to streamline the treatment to the market...

-according to Dr. Ziering.



Now who knows about Aderans? I feel like we are left in the dark for aderans..

[Dazza]

There seems to be a lot of confusion on when these treatments are supposed to make it to the market.


Can someone, WHO KNOWS FOR SURE, clear up when each of these should be released..

Thank you

Sorry bud, tho nobody on here KNOWS FOR SURE. Not one person even knows if this stuff will even make it to market let alone a release date. Best thing to do is just wait for the official updates. Everything else is just speculation. They have a time-line on there websites.

[hellouser]

2014 is the earliest release for Aderans, a projected date they set themselves at a public presentation.

Aderans had a presentation a while back, I think in 2010 so three years ago. They detailed their timeline and goals for their development and clinical trials. They outlined that Phase II trials would be finishing in 2013, right about now (between end of February and end of April). They're right on time with that as I think they have one or two trials left and they are ending within the next two months.

They mentioned they'd be starting Phase III trials basically immediately after so around April. Phase III they said would last them 1 year so they are planning on finishing in Q1 of 2014 (basically around between January-March). As well, they made claims they would release the treatment as a commercial product basically immediately after. Once 2014 rolls in, it will mark 12 years of research and development of their product. Which is far more than enough data that the FDA will need so there is NO excuse why the FDA should hold them back. There is *nothing* dangerous about using your own cells. They've given Merck with Finasteride a real fast approval in 1997 for their 1g pill. Its still on the market despite the high number of side effects people have and cases of permanent erectile dysfunction. But using your own cells? Thats like saying you can infect yourself; YOU CANT.

That reason alone should give immediate release of Aderans in clinics. That said, if the FDA stalls them I will go absolutely crazy and I swear by god I will move heaven and earth to get my hair back so any and all of you guys on the forum can expect me to do a LOT of rallying to open the doors for the clinics and treatments. I've mentioned these efforts before and I'm completely serious about it too, so if anyone wants to join me in efforts, let me know and we can work together to spread awareness and a real need for this. 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.

It should also be noted that Aderans bought out Bosley for abouit $160 million in 2011. You can bet that they know they have a working formula and will be using the clinics to administer their treatment.

If Aderans does release a product next year, I'll be at a Bosley clinic soon enough. If anyone wants, drinks will be on me for a major celebration.

Here's the 2010 presentation: http://www.aderansresearch.com/presentation/

Their timelines are shown nearer the end of the video.

[hellouser]

Here's a screenshot from the presentation video showing their projected timeline:



Remember, theyre ON SCHEDULE so 2014 looks like a possibility.

[Thinning87]

It should also be noted that Aderans bought out Bosley for abouit $160 million in 2011. You can bet that they know they have a working formula and will be using the clinics to administer their treatment.

Their timelines are shown nearer the end of the video.

That is actually a really good sign! I was not aware of that, very well.

About the timelines: I thought I had seen an extension to this timeline of about a year, in some previous posts...?

[hellouser]

That is actually a really good sign! I was not aware of that, very well.

It only makes sense. They need clinics to administer to procedure which they dont have, and for that to happen would require a *lot* of work and time; finding properties, closing purchases of places, potentially finding rent, renovations, city and health ministry approvals, etc. This would take a while and unnecessary extra waiting. With Bosley having all that already complete, all they need to do is modify the clinic slightly and add whatever tools necessary.

About the timelines: I thought I had seen an extension to this timeline of about a year, in some previous posts...?

No, theres no extension. Their last Phase II trial started in October of 2012 which is a 6 month trial. That is ending soon so Phase III is on its way. Seriously, next year could be a HUGE game changer. If the FDA stalls them I will have a psychotic burst of fury and will be out to destroy the FDA. No chance in hell am I going to let them screw us over.

[UK_]

Great information Hellouser - it was actually the Hair Club that Aderans purchased for 163m - but yeah another great sign.

I cant believe how fast those 3 years have gone jeez.

[Desmond84]

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.

Considering Phase 3 will take 18 months + 10 months FDA approval, Aderans should be available by Q4 2015!

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!

[Vox]

But using your own cells? Thats like saying you can infect yourself; YOU CANT.

This should not be taken lightly. You can have a cancer, or autoimmune reactions. And a cancer usually takes many years to develop.

"Playing" with your own cells may be pretty serious stuff.

[Vox]

If the FDA stalls them I will have a psychotic burst of fury and will be out to destroy the FDA.

Hell-riser then?

[FearTheLoss]

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!

[Banana Republic]

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.

[hellouser]

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!

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.

[garethbale]

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...