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eicoman

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eicoman

Re: eicoman post# 27479

Monday, 01/08/2018 9:05:15 PM

Monday, January 08, 2018 9:05:15 PM

Post# of 30352
Efficacy and CMC issues have been addressed, this approval is all about safety studies around DDAIP, since alprostadil has been approved for many years now.

In fact the FDA has never had an issue with Vitaros efficacy, even from the 2008 CRL, they did not cite efficacy as an issue. With this new submission Apricus has updated the statistical method on efficacy with feedback from the FDA.
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