In January 2023, upon acceptance of the new drug application (NDA) for vamorolone, FDA established the target Prescription Drug User Fee Act (PDUFA) action date for its regulatory decision on the NDA as October 26, 2023. At the mid-cycle review meetings, the FDA indicated that no significant review or safety concerns were noted up to that point in its ongoing review and re-affirmed its earlier decision to forego an Advisory Committee Meeting. Subject to approval, Santhera's licensing partner Catalyst Pharmaceuticals, plans to launch vamorolone in the U.S. early in Q1-2024.