(RTTNews) - BrainStorm Cell Therapeutics, Inc. (BCLI) announced Thursday 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.
The ultimate goal is to secure the FDA's agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application.
