BRIEF-Apricus Biosciences Announces Outcome Of Vitaros™ End-Of-Review Meeting With FDA [Reuters]
APRICUS BIOSCIENCES (APRI)
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Source: Reuters
BRIEF-Apricus Biosciences Announces Outcome Of Vitaros™ End-Of-Review Meeting With FDA | Reuters Reuters Staff 2 Min Read April 16 (Reuters) - Apricus Biosciences Inc: * APRICUS BIOSCIENCES ANNOUNCES OUTCOME OF VITAROS™ END-OF-REVIEW MEETING WITH FDA * APRICUS BIOSCIENCES INC - COMPANY EVALUATING STRATEGIC ALTERNATIVES * APRICUS BIOSCIENCES INC - COMPANY SEEKING PARTNER TO DEVELOP VITAROS IN U.S. * APRICUS BIOSCIENCES INC - FDA CONFIRMED DURING MEETING THAT COMPANY SHOULD DEVELOP A NEW VITAROS FORMULATION * APRICUS - PRELIMINARY END-OF-REVIEW MEETING MINUTES SUPPORT PLAN TO ADDRESS ISSUES CITED BY FDA IN ITS FEB 15 CRL FOR VITAROS NDA * APRICUS BIOSCIENCES - FDA ALSO CONFIRMED 2 NEW PHASE 3 CLINICAL EFFICACY TRIALS WITH REFORMULATED PRODUCT SHOULD BE CONDUCTED PRIOR TO RESUBMITTING NDA * APRICUS - IN ADDITION, FDA REQUESTED CERTAIN PHARMACOKINETIC ASSESSMENTS THAT CO EXPECTS CAN BE COMPLETED AS PART OF REQUESTED PHASE 3 PROGRAM * APRICUS BIOSCIENCES- FDA SAID CHEMISTRY, MANUFACTURING
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