BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS (Yahoo Finance) - Apr 9, 2024 - "BrainStorm Cell Therapeutics Inc...today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn in amyotrophic lateral sclerosis (ALS)....The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS....BrainStorm anticipates commencement of the Phase 3b study in 2024....We've been parallel processing to enable us to deliver the first dose in the trial in 2024...""
Special protocol assessment • Amyotrophic Lateral Sclerosis • CNS Disorders
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