Apricus Biosciences (Nasdaq: APRI) saw its market value take a nosedive on Friday following news that the company had received a complete response letter (CRL) for the New Drug Application of Vitaros (alprostadil, DDAIP.HCl), a topical cream for the treatment of erectile dysfunction.
The USA-based urology and rheumatology specialist closed at $1.04 on Friday, a fall of 67% compared to the previous close.
In the CRL, the FDA indicates that it cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to chemistry, manufacturing and control (CMC) and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
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