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BrainStorm announces high-level FDA feedback on NurOwn ALS clinical development program

Read time: 1 mins
Published:1st Mar 2021
BrainStorm Cell Therapeutics Inc. announced that it recently met with senior leadership from the FDA and received FDA feedback on a high-level data summary from the NurOwn (autologous MSC-NTF cells) ALS Phase III clinical trial. The FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that FDA is seeking to support a Biologics License Application (BLA). In addition, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA 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 Brainstorm Cell Therapeutics.
Condition: Amyotrophic Lateral Sclerosis
Type: drug

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