FDA news due any day now (hopefully good news!)
Original submission made on 30 March and substantive review completed in line with timeline (60 days). The 90 day review clock continues once the additional information has been received so if that occurred at the end of November we are well past 90 days.
Perhaps the board have already received the MDUFA decision and aren't releasing it yet???
FDA news due any day now (hopefully good news!)Original...
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