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

Repros Therapeutics Inc.® 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.