BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn Clinical Trial (PRNewswire) - Jun 26, 2024 - "BrainStorm Cell Therapeutics Inc...announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm's Phase 3b clinical trial for NurOwn, its investigational therapy for amyotrophic lateral sclerosis (ALS). This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial."
FDA event • Amyotrophic Lateral Sclerosis • CNS Disorders
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