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Re: Pazzo1212 post# 38080

Wednesday, 11/18/2015 7:36:33 AM

Wednesday, November 18, 2015 7:36:33 AM

Post# of 469661
It will be designed as a pivotal trial, meaning that if results are good the trial could be sufficient for FDA approval. I believe they are saying phase 2/3 at the moment because the company does not yet wish to reveal (or has not yet decided) whether to designate the next trial phase 2b or phase 3. Either way, it will be a randomized, double-blinded, placebo-controlled trial that could lead to FDA approval.
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