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motohead125

10/17/10 8:27 PM

#1089 RE: Superfly15 #1088

I think a non-approvable letter is a bit far fetched. The only concern that was expressed was the uncertainty of what caused tumors in rats at extreme doses and if it has ANY relevance to humans. The trials proved it was safe and effective.

I do believe we'll get a CRL asking for either clarification on the data, or another rat study where they are asked to determine the mechanism of the tumors. Still bs if you ask me. But thats how this crap goes. We shall see friday.