"Why would the FDA stop a PIII trial if the placebo drug hadn't had any adverse events? That's not the way it works".
Really ? yes it does.
Do you have an FDA background . If not ..please point me to any FDA document (rules & regulations) whereby they will allow P3 to proceed where P2 does not meet its primary end points. Remember P2 trials are not powered for efficacy ...so where you get efficacy as well , then you have a potential Paradigm shift in medicine (36 months + with no MACE on Cohort 3 patients). This was the view as well from Emmerson Perin MD - the independent principal investigator of the p2 trials (Texas Heart Institute).
And just to complete the discussion ( i feel embarrassed pointing to the obvious) ,if P2 didn't meet its endpoint ...
...TEVA would have pressed the button to MSB donkeys years ago ( bzzzzz) and no legal ramifications to TEVA whatsoever, as MSB would have been in breach of there deliverables. This is a fact. Instead when TEVA did a massive review of there R&D projects in 2012 and again in 2014 they elevated Revascor onto there pipeline. Even more telling when you understand that cardiology is way off Tevas franchise and applications.
The extent that TEVA went to (and who they spoke to) before commencing/proceeding with the P3 trials - that's what you need to find out Tuna.
Please Dyor.
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