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DewDiligence

12/21/07 12:34 AM

#6525 RE: croumagnon #6524

>Doesn't the advantage of Symptomatic DVT (Versus any DVT diagnosis) also carry in the control arm? If so, how is that an advantage since it may show less DVT's in the control arm as well?<

The restriction of efficacy events to symptomatic DVT rather than any DVT lessens the variability of the outcomes in both arms and thereby makes a finding of non-inferiority more likely.

>I suppose GTCB is trying to merely determine non-inferiority of ATryn as compared to plasma-derived antithrombin for approval, is that correct?<

Correct.

>would you happen to know if the trial has an SPA…<

Regrettably, it does not.