Monday, February 22, 2016 9:34:06 AM
You will know within 60 days of submitting your NDA whether it has been accepted for filing (or conversely, if FDA refuses to file your application). If your application is accepted for filing (60 days after submission), then you will receive a 74-day letter, which confirms your action date, confirms standard versus priority review, and identifies any preliminary deficiencies in your application.
Google it to learn about the process!
March 15 or 16, 2016 = FDA acceptance (could be sooner)
March 29 or 30, 2016 = "74-day Letter" (could be sooner)
July 15, 2016 = PDUFA date for ELI 200 - the date specified in the 74-day letter letting us know the FDA's goal date for review/approval.
Just estimates but you get the picture! Keep in mind, it could all happen sooner than these estimates.
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