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