Melville, N.Y.-based BioRestorative Therapies has secured a Type B meeting with the FDA to discuss an accelerated approval path for its fast-track-designated BRTX-100 program for chronic lumbar disc disease.
The meeting is scheduled for mid-December. In a Nov. 17 news release, the company said it plans to present safety and efficacy data from its ongoing phase 2 clinical trial, and request an expedited timeline to initiate a phase 3 trial in support of a biologics license application.
BioRestorative said it will share an update after reviewing the FDA’s written meeting minutes, according to the release.
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