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Re: BioSpecialist post# 18

Tuesday, 01/24/2017 2:11:26 PM

Tuesday, January 24, 2017 2:11:26 PM

Post# of 190
Bio- Where are you getting your timeframe on NT-201? PDUFA puts FDA action between 6 and 10 months for this and that's assuming it falls within the 90% target for FDA to act on NDAs submitted.

Priority submission is around 6 months while standard submission is around 10 months. I'm not sure which it is but it's definitely not within the next (now this) week or so.

I'd like to be misinformed on this but I have a hard time finding evidence supporting that.