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Re: vinmantoo post# 188921

Sunday, 03/22/2015 5:03:53 PM

Sunday, March 22, 2015 5:03:53 PM

Post# of 252302
vin..

if the FDA didn't feel that combining the corrupted Bavi arm with the supposed placebo arm to arrive at a new control arm was warranted, it's not hard to figure that they would have insisted on a repeat of PII. I expect there will be a response that says the company can do P3 if they want to anyhow, but I doubt very much that they would have in the absence of some data the FDA thought had merit.

btw, i am not one who is sure Bavi is a wonder drug. what i am more convinced of than i used to be is that the 3rd party vendor had a mighty big hand in screwing up the P2, and i suspect pphm has been unfairly tarred and feathered for it because of things they mismanaged long before...

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