BrainStorm Cell Therapeutics Announces In-Person Meeting With The FDA To Discuss Confirmatory Phase 3 Trial For NurOwn In ALS
Portfolio Pulse from Benzinga Newsdesk
BrainStorm Cell Therapeutics has scheduled an in-person meeting with the FDA on December 6 to discuss a confirmatory Phase 3 trial for NurOwn, its treatment for ALS. The company aims to seek a Special Protocol Assessment (SPA) for the trial.
November 20, 2023 | 1:12 pm
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BrainStorm Cell Therapeutics is set to discuss its Phase 3 trial for NurOwn with the FDA, potentially advancing the treatment's development and regulatory approval process.
The scheduled meeting with the FDA is a critical step for BrainStorm Cell Therapeutics as it may lead to the Special Protocol Assessment (SPA), which can facilitate the development and potential approval of NurOwn. A positive outcome from this meeting could significantly impact the company's prospects and stock price in the short term.
CONFIDENCE 80
IMPORTANCE 90
RELEVANCE 100