BioRestorative Therapies granted FDA meeting for potential accelerated BLA approval.
ByAinvest
Monday, Nov 17, 2025 7:03 am ET1min read
BRTX--
BioRestorative Therapies has been granted a Type B meeting with the FDA to discuss a potential accelerated BLA approval pathway for its Fast-Track-Designated BRTX-100 program for chronic lumbar disc disease. The meeting is scheduled for mid-December and the company plans to discuss positive safety and efficacy signals from its Phase 2 clinical trial and request an accelerated timeline for a Phase 3 trial.
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