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Re: waynebio post# 2083

Sunday, 12/03/2006 5:15:11 PM

Sunday, December 03, 2006 5:15:11 PM

Post# of 19309
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 perhaps a better question would be to estimate chances of this and other research encouraging significant off label use of Atryn in sepsis with DIC. The reason I think this question would be helpful is that if the consensus is that off label use would be low, then GTCB/Leo would need to commit to prospective (and expensive and risky) randomized trials in sepsis with DIC if they are to ever expand use beyond hereditary deficiency.

urche

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