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studythosestocks

05/20/19 8:15 AM

#192295 RE: Biobillionair #192289

??? Not following you. They have to report by day 60 for priority review. Never could find a policy on how it is handled if day 60 falls on weekend or holiday. I found some info if IV but not for NDA sNDA. I called FDA but basically they said to contact reviewer directly on how this is handled for “our” submission and don’t have that access. Nothing passive or aggressive. Just stating FDA guidelines as OY has also. No reason we shouldn’t get Priority Review unless FDA still doesn’t have a clue which I hope isn’t the case. Take care