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Re: kei post# 217216

Friday, 02/16/2018 9:00:33 AM

Friday, February 16, 2018 9:00:33 AM

Post# of 253213
APRI -73%/PM on CRL for Vitaros ED crème:

https://finance.yahoo.com/news/apricus-biosciences-receives-complete-response-120101399.html

The CRL indicates that the FDA 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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