Biotech Values

[DewDiligence]

...such a need is for secondary endpoint only.

From a regulatory standpoint (according to the SPA), statistical superiority of AXR-07 versus each of its constituent drugs is needed only on the 24-hour (secondary) endpoint, as you note. Nevertheless, I contend that failing to show statig superiority to either or both constituent drugs on the 2-hour (co-primary) endpoints will cause the trial to be considered less than an unqualified success.