Aderans

[krewel]

Phase III Finasteride results were presented in March 1997 and got approved in December 1997. Of course that was 15 years ago, but I can't imagine the same process taking 2-3 years in 2014 with a way more harmless treatment.

[hellouser]

Phase III Finasteride results were presented in March 1997 and got approved in December 1997. Of course that was 15 years ago, but I can't imagine the same process taking 2-3 years in 2014 with a way more harmless treatment.

THIS should be seriously considered. There clearly are ways to shorten the approval process, so the 2-3 year approval process could just be 2-3 months, but who knows. I'm going to stay positive and hope for the best (and expect the worst). However, since Aderans presented the 2014 timeline of a 'commercialized product' and didnt mention that it would be another (potentially) 3 years, wouldnt they know their investors would be really pissed off if they found the actual date is set for 2016/17? It almost seems like lying, I have a feeling they will be given the go ahead much sooner than the three years. And since the cells are *our own* theres really almost no way of developing complications... this alone compared to an actual drug with potential side effects should make the approval that much more swift considering finasteride's quick approval.

Oh, and seeing how much money would be involved with this, theres a ton of cash for Aderans to make.... which means a ton of taxes the us government would collect, which it BADLY needs considering USA's poor economy/debt. It'd be kind of stupid to say 'no, we dont want to make millions happy and collect some nice tax money'

*fingers crossed*

[JRQ]

Wow guys, this is awesome news. I honestly didn't mean to be a Debbie Downer about the Phase II, but I was on the phone with them for about 5 minutes at the SC branch.....she was extremely nice, but didn't exude competence sadly. They were one of the very last branches to end Phase 2 screening, so maybe that's what the aforementioned Arizona site was talking about.

I will be waiting for the FDA call thanks again guys!

[Joker]

No problem, JRQ. You helped get this thing started, and I'm ALWAYS an advocate of tempering enthusiasm where baldness treatments are concerned.

I think this is an area where Spencer Kobren can *hopefully* be of some help. Perhaps he can contact Aderans and inquire about this 2-3 year period after Phase 3? Maybe he has more resources than we do...

[mlao]

The bad news is this, and I really hope that this isnt the case... After the clinical trials are up, the FDA requires 2-3 years of more results/testing before giving the go ahead and having a final product on store shelves. So 2016/17 at this point seems more likely the case, BUT that also means that the presentation given in 2010 is also wrong since it *clearly* showed a commercial product in early 2014, which means a product for the public.

hellhouser, for clarification is this what the person you spoke to at Aderans said, or is this your own conjecture?

Because I think I once read that a company can began FDA approval assessment during phase III.

[eqvist]

Were can I see the phase II results?

[Joker]

There is no way to see the Phase 2 results until Aderans decides to release them. Very few hair loss companies reveal accurate and transparent sets of data to consumers.

Hopefully they release some positive trial data soon.

Sorry. :/

[stilted]

Phase III Finasteride results were presented in March 1997 and got approved in December 1997. Of course that was 15 years ago, but I can't imagine the same process taking 2-3 years in 2014 with a way more harmless treatment.

But are you taking into account the fact that 5mg of finasteride (proscar) had already been on the market for years and years? Surely marketing a 1mg tablet version of a pre-existing drug helped speed things along at the FDA.

[mlao]

Hellouser, sorry for misspelling your name - mlao

[southasian]

No problem, JRQ. You helped get this thing started, and I'm ALWAYS an advocate of tempering enthusiasm where baldness treatments are concerned.

I think this is an area where Spencer Kobren can *hopefully* be of some help. Perhaps he can contact Aderans and inquire about this 2-3 year period after Phase 3? Maybe he has more resources than we do...

Folks, getting FDA approval never takes 3 years. I remember researching about this approval part many years ago & that it normally takes about 6 mths or so. Here's a link below from Wikipedia that elaborates the process, and no i did not edit the details :-)

http://en.wikipedia.org/wiki/New_Drug_Application#The_actual_application

[hellouser]

hellhouser, for clarification is this what the person you spoke to at Aderans said, or is this your own conjecture?

Because I think I once read that a company can began FDA approval assessment during phase III.

lol, nice typo.

its what I was told over the phone with the lady on the other end. I hope she's wrong for *our* sake.

[Kiwi]

lol, nice typo.

its what I was told over the phone with the lady on the other end. I hope she's wrong for *our* sake.

Seriously guys. Just think about it. There is no way on earth the lady on the phone taking enrollment calls is on a high enough pay grade where she is allowed to talk about actual release dates - or for that matter is even told in the first place.

Seriously!!

[mlao]

Seriously guys. Just think about it. There is no way on earth the lady on the phone taking enrollment calls is on a high enough pay grade where she is allowed to talk about actual release dates - or for that matter is even told in the first place.

Seriously!!

That's kind of what I'm thinking. Aren't some of these facilities places where they do multiple clinical trials for different companies.

[hellouser]

Seriously guys. Just think about it. There is no way on earth the lady on the phone taking enrollment calls is on a high enough pay grade where she is allowed to talk about actual release dates - or for that matter is even told in the first place.

Seriously!!

Why would it matter if Aderans presented a 2014 commercial product date?

[534623]

Thats pretty damn impressive, I don't think their results could have gotten any worse, but even if 25% thats still impressive.

Heres the link to their 2010 presentation, some interesting stuff to listen to:

http://www.aderansresearch.com/presentation/

this pic is not impressive at all. according to dr washenik in this presentation, it just shows a facial skin sample from a lady who had a facelift; these few hairs on this skin sample grew outside the body in the lab and everybody knows that hairs still grow even if you’re dead. this means, in this pic, it’s even unclear what is what (new hair due to the procedure or just growth of the patients’ existing –sleeping- hairs. furthermore, aga in general or any other negative factors (hormones etc) or ‘real world situation factors’ who cause hair loss were not involved in this experiment.