I could certainly be wrong, but I believe when they submitted their request for rolling review and fast track they also submitted Part 1 of the NDA. If I'm correct about this, and if they truly intended to complete the process in the 6 months allowed in a fast track application, I believe they'd have needed to complete the NDA in 4 months after the initial submission, roughly the end of this year. While I agree it could have been done quicker, I also feel that doing it properly is more important than doing it quickly.
Hopefully they're doing it right, but will complete it late this year, or early next. I do think they will comment on this at the next quarterly. I would also hope we hear about the anticipated time line for all their other efforts, perhaps even an update on the companion diagnostic for AEZS-108, who's development is really not in their hands.
While I don't believe those running the Phase III for Perifosine in MM give them up to the minute data, I do believe they're updated on the number of events in the trial and they should be able to forecast the time of the first peek to at least which quarter it ought to occur. I really believe that 1st peek will generate no more than a recommendation they continue as even drugs which do spectacularly can rarely stop a trial at first peek, the FDA demands are exceptionally high at that point. The data from Phase II looked very good, but wasn't so spectacular as to anticipate a trials stoppage early.
Gary
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