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Re: Admiral38 post# 8278

Saturday, 01/09/2010 6:41:20 PM

Saturday, January 09, 2010 6:41:20 PM

Post# of 59550
Admiral - this is only my opinion based on what I have surmised from the many posts I have read about the timing of approval. Round trip of an initial filing is 90 days for the FDA to respond. If after 20 days the FDA responds with an AI (additional information) request than the clock starts ticking again with the balance of 70 days to go. It is however a 60 day time clock for the FDA to respond to an AI once they receive it. Again this is only what I have observed from the various postings I have read. Mike Nessen acknowledged that the receipt of the last submission by the FDA was on the 17th of November. This would bring us to lets say on or about January 17th. Take into consideration the holiday's since the RSNA and it could be extended a bit. Please read post #8228 (The last paragraph) it might clear it up a bit. See ya in the Winner Circle.