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Re: MunchMeat42 post# 92032

Wednesday, 07/08/2020 4:34:01 PM

Wednesday, July 08, 2020 4:34:01 PM

Post# of 232933
When did the FDA start the clock? April 27 with the main filing or May 11 when additional data tables were provided?

If April 27, Saturday is 74 days and the FDA has to respond.

If May 11, Saturday is 60 days, and there is an optional FDA response (per my reading) only in case of really good news (priority review) or really bad news (refuse to file).

All just my understanding.
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