Clinical Trial SetbacksONS-5010 missed the primary endpoint of non-inferiority at week 8 set forth in the special protocol assessment with the FDA.
Product Development ChallengesONS-5010 is the company's sole active development program.
Regulatory UncertaintyIt's not clear how the FDA is going to recognize the non-inferiority margin at week 12, which was not a pre-specified endpoint and there was no alignment before readout, so the agency will view this as an 'exploratory' endpoint.