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Biotech / Medical : Theravance - THRX

THRX 9.810

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Jan 8 4:00 PM EST

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To: Biomaven who wrote (40)	8/28/2006 2:13:49 PM
From: DewDiligence_on_SI	of 74

I don’t know of cases where this happened but it’s a theoretical possibility as explained in my reply to bio_kruncher. The FDA’s definition of non-inferiority varies greatly from trial to trial, especially in the medical-device arena where trials seeking a finding of non-inferiority are very common. The superior-but-not-non-inferior anomaly is bound to happen in due course if it hasn’t already. To sum up: the “two bites at the apple” logic does not apply to dual endpoints of superiority and non-inferiority if the statistical-analysis plan adheres to the Hochberg correction. However, the “two bites” logic does apply (at least in theory) if the SAP does not employ Hochberg. Regards, Dew

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