Cytodyn Inc (CYDY)

[Borel Fields]

SAEs are efficacy data in this environment. They are defined as any "untoward medical occurrence," whether caused by the treatment or the disease, that either (a) causes or extends a hospital stay, or (b) is life threatening or causes death. Because drug-caused adverse events are potentially significant, SAEs are arguably a more complete measure than the primary and secondary endpoints in the trial.

As a solo endpont, reducing the percent of patients with an SAE from 21.4% to 8.9% (a 58% reduction), was nearly significant with a one-sided p-value of .07.

Presumably, the more detailed clinical metrics will offer higher resolution (and lower p-values) than the blunt instrument of SAEs. (Also note a slightly different metric, total SAEs per patient, dropped 64%.)