GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Predicted-survival range in phase-2 DIC trial:

>limiting inclusion criteria to those with intermediate prognosis (i.e. recognizing that those with less severe disease and limited organ dysfunction will survive regardless, and those with the most severe cases will die regardless of treatment stratification)<

This key design feature of Leo’s phase-2 trial has been overlooked by the ATryn-in-DIC skeptics, IMO. Patients admitted into Leo’s trial must have predicted survival—based on an industry-standard model—in the 40-70% range. (I.e., predicted mortality must be 30-60%). For patients with predicted survival <40% or >70%, including them would place an undue burden on the statistical power of the trial for the reasons you cited.

If the 40-70% predicted-survival range works well in phase-2, I expect it will be expanded somewhat in phase-3, where the statistical power will be greater. Regards, Dew