Shares of BrainStorm are down over 40% in pre-market trading after the FDA submitted its briefing document regarding its “concerns about the consistency of the manufacturing process and potential sources of product variability” ahead of the Cellular, Tissue, and Gene Therapies Advisory Committee meeting on September 27th to discuss the company’s Biologics License Application for debamestrocel, or NurOwn, for treatment of patients with amyotrophic lateral sclerosis, or ALS.
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