Clinical TrialsONS-5010 missed the primary endpoint of non-inferiority at week 8 set forth in the special protocol assessment with the FDA.
FDA ResponseThe FDA issued a Complete Response Letter (CRL) for ONS-5010 due to several CMC issues and a lack of substantial evidence.
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.