BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn in ALS (PRNewswire) - Feb 23, 2024 - "BrainStorm Cell Therapeutics Inc...announced that it has submitted a Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA) for a Phase 3b study of NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS)....The submission follows an in-person meeting that BrainStorm held with the FDA in December 2023. The interactions leading up to this submission have provided guidance on advancing the planned Phase 3b trial....The response is expected within 45 days of submission."
New P3 trial • Special protocol assessment • Amyotrophic Lateral Sclerosis • CNS Disorders
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