STAT+: Brainstorm’s cell therapy for ALS lacks convincing clinical data for FDA submission, agency concludes
The Food and Drug Administration told Brainstorm Therapeutics that rejiggered data from a negative clinical trial does not support the submission of a stem cell therapy for patients with amyotrophic lateral sclerosis, or Lou Gehrig’s disease, the company said Monday,
Despite the FDA’s recommendation that Brainstorm not seek the approval of its patient-specific ALS treatment called NurOwn, the company may still do so, but will consult with outside experts first before making a decision.
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