BrainStorm Cell Therapeutics Announces Outcome of FDA Meeting on NurOwn in ALS (PRNewswire) - Dec 7, 2023 - "BrainStorm Cell Therapeutics Inc...announced the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS). The primary objective of the meeting was to discuss key considerations for a Special Protocol Assessment (SPA) for a planned Phase 3b registrational trial for NurOwn. As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA."
Clinical protocol • FDA event • Amyotrophic Lateral Sclerosis • CNS Disorders
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