Santhera Pharmaceuticals (SIX: SANN) announces that the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) has been submitted to the U.S. Food and Drug Administration (FDA). Finalization of the NDA submission to start the FDA official review is postponed by 4-6 months to Q4-2022 after a third-party contract manufacturing organization (CMO) communicated a delay in establishing FDA-inspection readiness. Santhera commenced the NDA filing as a rolling submission in March 2022 following a successful pre-NDA meeting with the FDA. In...