Nov. 17 at 12:02 PM
$BRTX BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease
https://www.globenewswire.com/news-release/2025/11/17/3188970/0/en/BioRestorative-Granted-Type-B-Meeting-with-FDA-to-Discuss-Accelerated-BLA-Approval-Pathway-for-BRTX-100-in-Chronic-Lumbar-Disc-Disease.html
“During the Type B meeting with the FDA, we plan on discussing the consistently positive safety and efficacy signals from our ongoing Phase 2 clinical trial of BRTX-100 in cLDD, as demonstrated by every new data analysis completed to-date,” said Lance Alstodt, Chief Executive Officer of BioRestorative. “We also intend to request an accelerated timeline for entering a Phase 3 trial to support our BLA application.”
Further updates will come after the receive the official minutes from the FDA (typcially 30 days after the meeting).
