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- Brainstorm Cell Therapeutics said it concluded a meeting with the FDA regarding NurOwn®, its treatment for ALS.
- The focus was on discussing a Special Protocol Assessment (SPA) for a Phase 3b trial.
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Brainstorm Cell Therapeutics Inc BCLI shares are trading lower by 22.6% to $0.23 Thursday afternoon after the company said it concluded a meeting with the FDA regarding NurOwn, its treatment for ALS.
The focus was on discussing a Special Protocol Assessment (SPA) for a Phase 3b trial. This SPA aims to gain FDA agreement on critical elements of the trial design to support a future marketing application. BrainStorm plans to submit necessary documentation outlined by the FDA following the meeting.
The company sees the SPA as a way to de-risk certain regulatory aspects and is committed to providing ALS patients with effective treatments. An SPA agreement doesn't cover every detail but signifies FDA support for key aspects of the trial design.
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According to data from Benzinga Pro, BCLI has a 52-week high of $54.60 and a 52-week low of $27.85.
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