FDA Alignment

The company has secured alignment with the U.S. Food and Drug Administration on the design of a future Phase 3 trial for BRTX‑100, covering primary endpoints, statistical powering assumptions, dosing strategy, and the overall development framework. The FDA reported no safety concerns and confirmed that BioRestorative’s manufacturing control framework is adequate for late‑stage development. The presentation of blinded data, coupled with the planned unblinding of the Phase 2 study, positions the company to advance protocol planning and other Phase 3 readiness activities.