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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