regulatory
confidence high
sentiment neutral
materiality 0.75
FDA schedules advisory committee meeting for BrainStorm's NurOwn BLA on Sept 27, 2023
BRAINSTORM CELL THERAPEUTICS INC.
- FDA Cellular, Tissue and Gene Therapies Advisory Committee to review NurOwn BLA for ALS on September 27, 2023.
- PDUFA target action date set for December 8, 2023.
- Company states confidence in data supporting regulatory approval and commitment to ALS community.
- BrainStorm notes FDA regulatory flexibility and ongoing work with ALS experts on rigorous clinical study.