Provectus Pharmaceuticals Inc. Message Board

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Biotech / Medical : Provectus Pharmaceuticals Inc.

PVCT 0.0630

-1.6%

Nov 28 9:30 AM EST

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To: PCskibum who wrote (11190)	4/25/2012 2:47:06 PM
From: Mammon	1 Recommendation Read Replies (1) of 13111

I'm no expert on the FDA and its proceedings, but a quick google search came up with this document about Incyte's dealings with the FDA and how many iterations they went through before reaching a trial design consensus for an SPA with the FDA. The articles notes "Levy estimated the company spent about five months and went through three iterations before reaching consensus with the FDA on the SPA." And this was after a much longer period of time back and forth on the trial design. Let me say this again, in case anyone started drinking early today. The word ITERATIONS is mentioned in the context of interfacing with the FDA regarding an acceptable trial protocol. docs.google.com

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