BioRestorative Therapies (NASDAQ:BRTX) has announced that it has been granted a Type B meeting with the FDA to discuss a potential accelerated Biologics License Application (BLA) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc disease (cLDD). The Type B meeting is scheduled for mid-December.
In a statement, Lance Alstodt, CEO of BioRestorative, commented, “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. We also intend to request an accelerated timeline for entering a Phase 3 trial to support our BLA application.”
In accordance with standard industry practice, BioRestorative plans to wait to provide investors with further updates on the Type B meeting until such time that it has received and reviewed the written meeting minutes from the FDA.
