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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.
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