BrainStorm Cell Therapeutics: FDA Grants In-person Meeting To Discuss Best Path Forward For NurOwn

(RTTNews) - BrainStorm Cell Therapeutics Inc. (BCLI) announced the FDA has granted the company a meeting to discuss the regulatory path forward for NurOwn in amyotrophic lateral sclerosis. The meeting is scheduled to take place on December 6, 2023.

Chaim Lebovits, CEO of BrainStorm, said: "Our proposed plan is to conduct a confirmatory Phase 3b trial and it is important that we are aligned with the Agency on the expected requirements for re-submitting a Biologics License Application. We believe that reaching an agreement through a SPA on the overall protocol design and the adequacy to address the requirements for marketing approval will be a key step to position the company for success and to potentially de-risk the program."

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