February 22, 2021 12:39pm

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The FDA's initial review concluded that current data NurOwn P3 trial in amyotrophic lateral sclerosis (ALS) does not sufficiently provide the threshold of substantial evidence to support the marketing application.


Also, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a marketing application submission.

"Brainstorm will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision," said Chaim Lebovits, CEO.