BrainStorm (BCLI) Cell Therapeutics announced that the U.S. FDA has cleared the company to initiate its Phase 3b clinical trial of NurOwn for the treatment of amyotrophic lateral sclerosis. The trial design was previously agreed upon with the FDA under a Special Protocol Assessment (SPA), confirming the study’s endpoints and statistical methodology are appropriate to support a future Biologics License Application submission. This clearance allows the company to proceed with patient enrollment.
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