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Spideyboy

12/01/20 10:07 AM

#3327 RE: midastouch017 #3326

I would think giving 2 PDUFA dates and pushing both back would be slightly irresponsible of the FDA to do that. I mean, they could have just said PDUFA date postponed indefinitely until travel restrictions are lifted which allow visit of FDA staff, or something to that effect. But if after what assume by the FDA is careful consideration and with the Covid situation not particularly improving globally, to provide a second PDUFA I do hope would mean it wouldn't be postponed again. PRX-102 does have Priority Review which should rank it high on the list, after Breakthrough Designation, but before the great majority of others compounds.