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DewDiligence

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DewDiligence

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Re: DewDiligence post# 69684

Tuesday, 12/09/2008 5:57:16 PM

Tuesday, December 09, 2008 5:57:16 PM

Post# of 253254
Albuferon clarification: In #msg-34043876, I said the following:

>>
The primary goal of the study was to show that Albuferon
dosed biweekly was non-inferior in SVR to Pegasys dosed
weekly. Albuferon achieved an SVR of 80% vs 85% for
the Pegasys arm; the 5% difference was less than the 12%
non-inferiority margin in the SPA and hence the trial is
considered a success.
<<

I should have made it clear that the 12% non-inferiority margin specified in the SPA was 2-sided—i.e. the 1-sided margin was only 6%.

Thus, the observed outcome in which Albuferon was 5% worse than Pegasys was a squeaker, not an easy success.


“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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