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FDA Receives Repros' Submission for Special Protocol Assessment Documentation for Pivotal Studies for Androxal

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Repros Therapeutics Inc.® (Nasdaq: RPRX) today announced it has received confirmation of delivery of the required documentation for Special Protocol Assessment of its Androxal® Phase 3 pivotal studies to the FDA. Per the Prescription Drug User Fee Act ("PDUFA"), the FDA has 45 calendar days to provide comments back to Repros.

Posted-In: News FDA

 

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