You are full of shxt!!!
Do you know that 90% of pre-clinical efficacy findings dont translate into clinical findings....Likewise, only 1 in 12 phase 1 drugs reach to phase III and beyond?? Also are you also aware that positive POC phase 2 100 patients studies dont translate into positive findings in the phase III???
Drisa was positive in phase 2 with greater than 100 patients trial....but failed larger phase III....
So now you are advocating that a so called POC trial (its actually a small exploratory) 12 patient (sorry only 10 now) trial can lead to a positive in phase III trial and should be approved????
Anyone can file an NDA even if FDA recommends not to.....Check AVEO.
NDA can be filed over protest....Regulations allows this in the US. Sarepta was advised not to but they did it anyways!!! FDA wants to put an end to this nonsense in a legal way.....NOT APPROVED!!!
You are incorrect!!! FDA cannot stop someone not to file an NDA. CLDX was more rationale, it decided not to file taking FDA's recommendation. AVEO went against FDA's recommendation during Pre-NDA meeting and submitted NDA. Look what happened after the Advisor Committee meeting. I'm sure sarepta was advised by the FDA not to file NDA without the phase 3 confirmatory trial. But it did anyways!!! FYI-One could file an NDA over protest.......This is in current regulations....
First of all, the accelerated program is in existence since 1992 when AIDS epidemic was rampant!!! So arguing that 2012 FDASIA allows accelerated approval of drugs for sham trials like Sarepta's is #$%$ and BS. Even during those dangerous times of AIDs deaths rampaging the world, FDA did not approve drugs based on small exploratory trials!! How can these scam artistes with their Regulatory head from the UK, with no experience in the US, can expect approval based on a 10 patient exploratory trial??? This article is full of BS and lacks support or rationale. 10 patient trials, repeat 10 patient trial.............they really have the nerve and thinks FDA and American public are so stupid!!!