Apricus Bio (APRI) Files Response with Swissmedic Related to Vitaros MAA; May Trigger Pre-Decision
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Apricus Biosciences, Inc. (Nasdaq: APRI) announced that the Company has filed its response to questions received from Swissmedic, the Agency for Therapeutic Products in Switzerland, relating to its marketing application previously filed for Vitaros, the Company's lead product candidate for the treatment of erectile dysfunction in Switzerland.
The filing of the Apricus Bio response triggers a 90-day review process, after which if found acceptable, may then trigger a pre-decision by Swissmedic for the approval of Vitaros for ED in that country. Following a subsequent approval decision and any required Company responses, Apricus Bio would then be required to supply Swissmedic with the final labeling and pricing information of Vitaros, which could take an additional 90 days for review and acceptance before that product can be marketed in Switzerland.
Apricus is currently in discussions with multiple potential commercial partners for Vitaros® for ED in Switzerland.
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The filing of the Apricus Bio response triggers a 90-day review process, after which if found acceptable, may then trigger a pre-decision by Swissmedic for the approval of Vitaros for ED in that country. Following a subsequent approval decision and any required Company responses, Apricus Bio would then be required to supply Swissmedic with the final labeling and pricing information of Vitaros, which could take an additional 90 days for review and acceptance before that product can be marketed in Switzerland.
Apricus is currently in discussions with multiple potential commercial partners for Vitaros® for ED in Switzerland.
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