GTC Biotherapeutics (fka GTCB)

[waynebio]

Survey question

1: What do you think is the closest probability of eventual approval of AT for DIC in Sepsis based on review of the clinical paper “Treatment effects of high-dose antithrombin without concomitant heparin in patients with severe sepsis with or without disseminated intravascular coagulation”.


<I would want to see a choice of zero. This paper is not sufficient for approval, IMO.>

I think you missed the point of question 1. The point is to get people to look at the paper and provide feedback/insights into the probability of success of the prospective clinical trials already planned for AT in DIC with Sepsis. Of course you can't submit this paper for regulatory approval.

I agree it would be interesting if off-label use were significant for AT in DIC. Leo must think it will be too insignificant so they seem to be starting phase II.

I feel that the paper shows a lot of value for AT in DIC. I hope that people will look at it carefully and provide some very specific feedback.