"The division will inform the applicant in writing of a priority review designation by day 60 of the review. The division will inform the applicant of a standard review designation in the filing communication by day 74 of the review."
Sounds like day 60 is a very important predictor whether priority or not. I'm trying to find how they respond if falls on weekend or holiday. Day 60 for us will be on Memorial Day.
Question we all have to ask ourselves and contemplate is if we get standard review, why? What about this drug does not meet qualifications for PR? Too many pages to cover in 6 months the reason? FDA not sold on data? More sinister reasons? Not saying we don't get PR. I strongly feel we do but as someone posted earlier, until we cross the finish line with an sNDA under our belts there will always be a little anxiety for me. Not that I don't believe in V's wonderful life saving effects but because I don't know whether those who can make this decision truly understand its great value currently to the world.
I'll see if I can find something about day 60 on weekend and post if I do.
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