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Thursday, 03/03/2016 2:06:09 PM

Thursday, March 03, 2016 2:06:09 PM

Post# of 403123
March 14 or 15, 2016 = FDA acceptance (could be sooner)and March 28 or 29, 2016 = "74-day Letter" (could be sooner)!

FDA will make acceptance decision within 60 days of RECEIPT of SUMITTAL!!!! "74-day Letter" follows 14 days latter (60 + 14 = 74)

NDA was submitted 14 JANUARY 2016!!!!!!!!
Some people may argue that FDA acknowledgement of the receipt of the NDA in a letter to Elite dated January 25 is the date of receipt but I would argue with that as the FDA letter states the receipt date of 14 January!

It could all happen SOONER but the above is the timeframe specified by the FDA!



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