Apricus Bio has work to do before refiling U.S. marketing application for ED cream Vitaros; shares down 10% premarket [Seeking Alpha]
APRICUS BIOSCIENCES (APRI)
Last apricus biosciences earnings: 11/2 04:01 pm
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Source: Seeking Alpha
Apricus Bio has work to do before refiling U.S. marketing application for ED cream Vitaros; shares down 10% premarketNano cap Apricus Biosciences (NASDAQ:APRI) slips10% premarket on light volume on the heels ofFDA feedback that it needs to develop a new less-concentrated formulation of erectile dysfunction (ED) cream Vitaros (alprostadil, DDAIP.HCL) and conduct two new Phase 3 studies with the reformulated product before refiling its marketing application. The company received a CRL in February citing safety concerns and deficiencies in Chemistry, Manufacturing and Control (CMC) data.The agency also wants to see certain pharmacokinetic results and an updated CMC section as part of the package.Previously:FDA rejects Apricus Bio's ED cream Vitaros(Feb. 16)Click to subscribe to real-time analytics on APRINow read:Biotech Forum Daily Digest For February 16th »
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