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Re: OldtimeramI post# 27367

Wednesday, 08/30/2017 12:51:23 PM

Wednesday, August 30, 2017 12:51:23 PM

Post# of 30353

-End of October for possible FDA acceptance of the NDA resubmission.
-End of April for FDA decision on NDA resubmission.



According to the Apricus Bio news release they expect the FDA to acknowledge the NDA resubmission within 30 days and by the FDA doing this, shorten the FDA decision to the end of March ( vs. end of April ) in my scenario.

SAN DIEGO, Aug. 29, 2017 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today reported that it recently filed its resubmission of a New Drug Application (“NDA”) for Vitaros™ (alprostadil, DDAIP.HCl) with the U.S. Food and Drug Administration (“FDA”). Apricus anticipates a six-month review by the FDA with a projected PDUFA (Prescription Drug User Fee Act) goal date in the first quarter of 2018, which it expects the FDA to acknowledge within 30 days of the NDA filing date.



So depending on if and when the FDA actually accepts for review the NDA resubmission is where the 6 month time frame would start.
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