FDA advisory panel overwhelmingly rejects ALS treatment from BrainStorm Cell Therapeutics
- FDA advisory panel voted 17-1 against experimental ALS treatment NurOwn, with one abstention.
- FDA deemed BrainStorm's treatment data "scientifically incomplete" and "grossly deficient."
- BrainStorm's single 200-patient study failed to show NurOwn extended life, slowed disease progression, or improved mobility.
- ALS patients and advocates unsuccessfully pushed for FDA approval through petitions and a public meeting.
- FDA expected to issue final decision on NurOwn by December 8, 2023.