BrainStorm Cell Therapeutics Announces Outcome Of FDA Meeting On NurOwn In ALS
Portfolio Pulse from Benzinga Newsdesk
BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI) announced a productive meeting with the FDA regarding NurOwn, its ALS treatment. The meeting focused on a Special Protocol Assessment (SPA) for a Phase 3b trial, aiming to secure FDA agreement on trial design elements critical for future marketing approval. BrainStorm will submit documentation for the SPA, and the company's CEO expressed commitment to advancing NurOwn's regulatory path.
December 07, 2023 | 1:41 pm
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BrainStorm Cell Therapeutics Inc. had a successful meeting with the FDA to discuss the Phase 3b trial of NurOwn for ALS, which is a positive step towards future marketing approval.
The successful outcome of the meeting with the FDA regarding the Special Protocol Assessment for NurOwn's Phase 3b trial is a significant positive development for BrainStorm. It suggests that the company is on the right track to meet regulatory requirements for a future marketing application. This news is likely to be viewed positively by investors, as it reduces regulatory uncertainty and indicates progress in the drug's development pathway.
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