BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) announced that the US FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn® in ALS. The meeting, scheduled for December 6, 2023, will focus on plans for a Special Protocol Assessment (SPA) for a confirmatory Phase 3 trial in ALS. BrainStorm aims to align with the FDA on protocol design and marketing approval requirements for NurOwn.
