Adcomm recommends FDA reject BrainStorm's ALS drug after company filed over protest
A panel of independent experts on Wednesday recommended the FDA reject an experimental ALS drug developed by the biotech BrainStorm Cell Therapeutics, marking another defeat for the long-embattled company.
Members of the Cellular, Tissue, and Gene Therapies Advisory Committee said by a 17-1 vote that BrainStorm’s drug, known as NurOwn, did not demonstrate substantial evidence of effectiveness for the treatment of mild to moderate ALS. The FDA has until Dec. 8 to approve or reject the drug.
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