MindMaze Therapeutics Holding (RLFTF)

[nelskof]

Wow. Just wow.

Based on feedback from the FDA, the company determined that the 70 patients targeted for enrollment in each of the VANGARD trial’s treatment arms would be insufficient in size to adequately evaluate mortality and that at least one additional clinical trial with a mortality endpoint, would be required.

After an interim analysis of the first 25 patients, PhaseBio did not observe any data trends in the 40 mg or 100 mg pemziviptadil-treated arms suggesting a reasonable probability of achieving the primary efficacy endpoint. Pemziviptadil was generally well tolerated, and no safety concerns were identified.