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Re: randychub post# 7085

Friday, 01/18/2008 7:13:46 PM

Friday, January 18, 2008 7:13:46 PM

Post# of 19309
>I own GTCB but I do think the market size given for sepsis has been fluffed.<

I respectfully disagree. Even if ATryn is ultimately approved with a label that specifies a middle range for predicted survival, I expect it will garner significant off-label DIC/sepsis use at the low and high ends of the severity spectrum. The only competition to date at the high end of the severity spectrum is Xigris, and no one outside of LLY thinks Xigris is a good option. There is no existing competition at the low end and midrange portion of the severity spectrum.

Limiting the ATryn DIC trials to the midrange portion of the severity spectrum is the right approach for maximizing the statistical power of the trials and hence the probability of regulatory approval.

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