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Tuesday, March 08, 2016 8:56:45 AM
Nasrat Hakim knows the timeline but gave a range of 6 to 12 weeks because if you give a specific date or week and it did not come in then people like some on here would be screaming the sky is falling. We are within a week of knowing and some here are already saying 6 to 12 weeks to try to confuse the DD that has already been posted. So just watch, we will see news VERY SOON!
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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