regulatory
confidence high
sentiment positive
materiality 0.70
BrainStorm announces FDA meeting on Dec 6 to discuss SPA for NurOwn Phase 3b in ALS
BRAINSTORM CELL THERAPEUTICS INC.
- FDA granted in-person meeting scheduled for December 6, 2023, to discuss NurOwn's regulatory path in ALS.
- BrainStorm plans to seek Special Protocol Assessment (SPA) agreement for a confirmatory Phase 3b trial.
- Company aims to align with FDA on re-submission requirements for Biologics License Application (BLA).
- CEO states SPA agreement could de-risk program and position company for success.