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Atom0aks

11/26/19 9:12 PM

#230394 RE: marzan #230393

Those other two MRC petitions can be denied on the basis of the approval of the very same sNDA itself. Federal agencies can do that simply stating the approval as the reason for the denial. They will say in that letter why they approved the sNDA that justifies the denial of those petions on such and such reason. Matter closed. We might see sNDA approval first thing in the morning, imo.



Well, if we are taking bets, I think the FDA will take advantage of the late December PDUFA date and approve sometime during the last two weeks.