Aggiornamento:
Sul forum Bald Truth Talk alcuni utenti hanno chiamato varie sedi Aderans ed hanno ricevuto buone notizie :
- Alcune sedi sono già in fase 3 ( quindi funziona), altre ci stanno passando
- I tempi sono quelli previsti inizialmente, ovvero quest'ultima fase dovrebbe richiedere poco più di un anno, quindi si parla di 2014
- La FDA non c'entra nulla ( di solito ci vogliono 6 mesi), innanzitutto dipende dal paese di commercializzazione e dalle leggi di quest'ultimo, inoltre viene ricordato che per Propecia l'approvazione arrivò in qualche mese
- PUNTO DUBBIO : Da quello che ho capito non dovrebbe funzionare per chi ha fatto il trapianto.
P.s. vediamo la conferenza di Ottobre, per ora starei coi piedi per terra, anche se per entrare in fase 3 è evidente che hanno qualcosa in mano.
Vi posto la discussione in inglese:
Christ, I just checked the call recording quality and it is absolute CRAP. I can barely hear the girl that was on the phone with me, the quality is so bad its pretty much inaudible. I should mention I was at a restaurant with a lot of ambient noise.... I'll make another call to another location from home where its quiet, I should get a better recording (I'm really pissed).
In short, YES, they are taking in participants for Phase III as their Phase II trials have ended. Each location is in different phases, but again according to the clinical trials page online, all of them are in AT LEAST in the end of phase II. She also mentioned that Phase III will probably take around a year so the 2014 projected date they set in 2010 seems legit.
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.
The great news is this:
They are only injecting a few hundred cells and their results are great, she mentioned the patients are walking out with THICK terminal hair so their solution is working. Of course, this was only a few hundred injections which means we could expect more hair or better results with more injections. I asked about the temple areas and she couldnt give a response since they are only focusing on the crown area. I wonder though, if the hairline/temples would require additional information or longer wait periods for the FDA to give clearance on their procedure.
I can put up the recorded conversation if someone knows a site where I can upload and share a 15mb file, but its really moot as the quality is absolutely awful (you can hear me just fine, but not the woman on the other end is very faint). I'm really pissed because she had a lot of great answers for me and its a 10 minute conversation, plus she mentioned shes with the company for 5 years.
Regardless, we're going to have much better information by january when aderans gives us their update.
fonte: http://www.baldtruthtalk.com/showthread.php?t=8590&page=39
