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News  ›  GlobeNewswire Inc.

BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Biorestorative Therapies, Inc.
BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease

BioRestorative Therapies has been granted a Type B meeting with the FDA to discuss an accelerated Biologics License Application approval pathway for BRTX-100, a stem cell-based treatment for chronic lumbar disc disease, with plans to request an expedited Phase 3 trial timeline.

Insights
AAPL   neutral

Mentioned as a customer of TSMC, no specific performance details provided


BRTX   positive

Company received FDA meeting for potential accelerated approval, has Fast Track designation, and is progressing clinical trials for a novel stem cell treatment