The refusal of File asks for further studies to establish efficacy. This would have DEFINETELY would have been discussed at a pre-NDA Meeting Thus it begs the questions Was there a pre-NDA Meeting ? (Highly suspect if none was requested) And if so, why did Alkermes file irrespective of the Division's opinion that the current set of studies didn't established efficacy conclusively? Maybe investors were mislead.
What a mismanaged cluster! Who is responsible for this? Shouldn’t we have known this well before we ever submitted. Who will be fired over this screw up?
Well in two out of three phase 3 trials it missed its primary endpoints. I guess management thought that a lot of positive talk and some wishful thinking would convince the FDA to approve it. The FDA wont even review the POS.
Maybe someone from R&D can post? How can we trust our idiot leaders if they can’t even represent what the FDA told them over the years?
I'm starting to think those assholes at the FDA prefer actual facts and supportive data over rosy talk. WTH?
I'm holding out hope that this is just a late April Fool's day joke by the FDA and that at the end of the day the FDA will say April Fool's MFs! Your drug is approved!
Press Release- Date(s): 21-Aug-2017 7:00AM The FDA Fast Track designation is designed to facilitate the development and expedite the review of medicines that are intended to treat serious conditions and address unmet medical needs. Fast Track designation allows for the submission of completed portions of the NDA on a rolling basis as well as eligibility for Priority Review. At a pre-NDA interaction with FDA in July, the company and FDA agreed upon the proposed content and timing of the ALKS 5461 NDA submission.
Dude lay off the late night sauce and proofread before you post. Probably the same guy who has spelling errors on his resume...douche
Every other company for every other Antidepressant that's been approved has had to show TWO positive trials to show efficacy for the primary endpoint. Somehow management thought they can cherry-pick data from the failed trials to make them the exception in pharma and submit with 1 positive trial. Guess the strategy backfired.
Regulatory should have talked this one over with the FDA Project Manager - fast track designation will have allow some level of discussions to prevent a Refuse-2-File. Clear to me, that Regulatory and CMO are not quite at the level that one would have hoped. Too bad - my investment tanked This time, it wasn't Trump (the giant orange half-baked pussy muffin)'s fault.
