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DewDiligence

12/03/06 3:46 PM

#2085 RE: waynebio #2083

Discussion and survey re DIC program:

waynebio: I’ll allow your post to percolate for about 24 hours so that other may chime in about additions, subtractions, or modifications to the survey questions and answer choices. Then I’ll set up the survey. Regards, Dew
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urche

12/03/06 5:15 PM

#2086 RE: waynebio #2083

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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DewDiligence

12/04/06 9:00 PM

#2109 RE: waynebio #2083

Does anyone else have an opinion about the proposed survey in #msg-15245725? Has anyone read the paper? Comments?