GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>“Primary Outcome Measures: Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.” Is this not considered as Survival benefit (that needs to be met)?<

Survival is a secondary endpoint in this phase-2 study. The primary endpoint is the proportion of patients having an improvement in DIC at day 28. The proviso that patients must be alive at day 28 in order to be considered improved is redundant (you can’t be improved if you’re dead).

In the phase-3 trials, survival per se will be the primary endpoint. Regards, Dew