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game7alcs

04/27/16 1:09 PM

#4666 RE: joe_techi #4665

Did I read that right that they have already said it will be 6 months instead of the 2 months were were hoping for?

A six month review period has been assigned for the resubmitted NDA, and the new Prescription Drug User Fee Act (PDUFA) date will be October 22, 2016.