GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: DIC program / control arm

>from your post I gather controls will be eligible for treatment with plasma-derived ATIII where available. almost seems like a non-inferiority would be most appropriate if an inordinately high proportion of docs, based on kybersept, already tend to treat with ATIII/no heparin, no?<

I’m assuming that plasma-derived AT will not be allowed in the control arm because otherwise the trial design makes no sense from a business standpoint. GTC and Leo want a label that specifies superiority in survival relative to treatment without antithrombin.

The looseness of the control arm pertains mostly to the lack of specificity about the use of—and dosing of—Xigris.