BrainStorm Says Type A Meeting With FDA Granted For NurOwn

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) said that the U.S. Food and Drug Administration has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company's New Biologics License Application (BLA) for NurOwn for the treatment of amyotrophic lateral sclerosis or ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.

The company said it looks forward to the Type A meeting which will provide an opportunity to discuss the path forward for NurOwn in ALS, including a possible Advisory Committee Meeting.

The company believes that an Advisory Committee Meeting would serve as an important part of the review process and would provide an open forum for BrainStorm, together with medical experts, statisticians, patients and other members of the ALS community to discuss the body of clinical evidence supporting NurOwn.

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