Nice post PJ and nice follow up question from WAG.
The concern for me is if the "above was completely predictable" then why is management trying to enter a P3 without a strategy. What, did they hope the FDA wouldn't notice the dose has been upped!!
Communication at an all time low with SP reflecting that. Lower than what I entered in some 8 years ago.
Bottom line is that this is actually a good thing... if we can enter a P3 with doses up to say 800 then we'll likely see stronger efficacy and at the same time shine a big spotlight on AD studies with potential correlation.
Ann: FDA End-of Phase 2 Status Update, page-41
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