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Biotech / Medical : Apricus Biosciences

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To: apriluv who wrote (1824)	4/6/2016 10:25:33 AM
From: eico20	of 2026

the carcinogenic study is no longer an issue, was resolved long time ago, the last corp presentation shows what they have to do, would be nice to get mid east Vitaros going since the Canada situation was holding it back, they really have no choice now but to cut all development and get money form Vitaros, let's hope Vitaros can eventually live up to it's potential, they may have to go on the pink sheets to save money as well Summary of Deficiencies ?Non-Approvable/Complete Response Letter (CRL) received –July 21, 2008 ?No additional clinical studies expected ?Approvability issues focused on: ?Possible risk with our permeation enhancer -DDAIP ?Safety risk to partner ?Acceptability of fill overage Plan of Action –Shift Benefit/Risk Profile ?2.5% DDAIP risk issues have been successfully addressed resulting in approvals in 22 countries in Europe and Canada ?EU and Canada allowed Apricus to label around the partner safety risk ?Transition to dispenser with a new material of construction underway ?Potential to enhance stability profile/shelf-life versus existing dispenser ?Manufacturing site change since NDA addresses site related deficencies

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