If you design a Phase 2 to be a Pivotal Phase 2, is this type of trial to be considered to be a Phase 3 final result trial by the FDA, or do they consider this to be some sort of play on an accelerated approval?
For instance, ARIA's Ponatinib trial (PACE), designed as a pivotal study.
I guess what I'm trying to get at is there an "overlap" in what is considered accelerated approval and can the FDA simply say, after results of a Pivotal Phase 2, "no. we need more. Spend another $20 million and 3 years and get back to us later."
From what I can recall, IMGN (with T-DM1) tried to get accelerated approval, I think? However, that trial, by design, wasn't a Pivotal Phase 2, it was just a wide randomized trial. The FDA declined approval and now results will not be out (in a drug which clearly worked) til 2012.
So, even you design a huge Phase 2 double-blind, randomized trial (not a Pivotal), and results are overwhelming, would you be better off "calling" it a PIVOTAL trial (instead of just a regular P2), or do you need to talk to the FDA about this before hand?
I'm just taking a look at a couple of pivotal P2's (like CRIS GDC-0449 and ARIA PACE trial), and trying to think of what the FDA can do to possibly screw these two companies like they have others in the past (and also let others in when they shouldn't have).
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