FDA calls out Brainstorm’s ALS stem cell therapy, says data don’t show benefit

The FDA almost never reveals its thinking about a drug prior to issuing a regulatory decision, and when that decision is a rejection the letter to the company is always confidential. Brainstorm Cell Therapeutics hasn’t even submitted its amyotrophic lateral sclerosis therapy for review, but the regulator has taken the unusual step of publicly stating that the company’s clinical data are insufficient.
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