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Biotech / Medical : Provectus Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: Mammon who wrote (11195)	4/25/2012 4:09:02 PM
From: TheMaster	1 Recommendation Respond to of 13111

Did You read my post? He always does the exact same thing hes like an Ink Blot. Once cornered and u step on him he splashes somewhere else?

To: Mammon who wrote (11195)	4/25/2012 5:21:07 PM
From: NTTG	2 Recommendations Respond to of 13111

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?