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To: PCskibum who wrote (11190)	4/25/2012 2:47:06 PM
From: Mammon	1 Recommendation of 11980

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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To: Mammon who wrote (11195)	4/25/2012 5:21:07 PM
From: NTTG	2 Recommendations of 11980

Not really. The decision at 45 days is all or none. The company either gets approval based on the submission or they don't. During the review the FDA typically does not ask for supplemental information, and I have never heard of a reviewer calling the company for 'clarification' on a point. They review the application as written. For applications that do not get approved notification may include insight on the deficiencies that need to be addressed in the revised application (generally when the company is close, I suspect per the example you cited) or they simply notify the company that the proposed study does not meet the standard (as I suspect will happen). Either way, a new submission is the next step, and in some cases the company has to loop back to gain additional insight on where the problems were, a time consuming process for sure. All the while the clock is ticking, and if you assume there are potential partners in the wings, they are watching. Any luck finding an FDA approved drug that has not published this clinical trial data?

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