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Re: inv10001 post# 31891

Wednesday, 07/29/2015 12:06:27 PM

Wednesday, July 29, 2015 12:06:27 PM

Post# of 48316
OK like I asked before, what is the precedent for approval based on a 41 patient investigator sponsored open label trial? FDA is an organization that is built on precedent so if one is going to make a credible claim that THIS is a pivotal study, then one should be able to provide precedent.

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