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Re: govprs post# 6356

Saturday, 07/10/2021 7:22:19 PM

Saturday, July 10, 2021 7:22:19 PM

Post# of 6939
That would be extremely rare, although it seems a bit odd to me that the FDA said they didn’t need a committee review but wanted a meeting a month before the PDUFA date.

Normally it’s more or less all or nothing with these reviews and if anything changes or more info is needed, it sets everything back 3-6 months.

GLTA,

Murocman