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Biotech / Medical : Cell Therapeutics (CTIC)

CTIC 9.090

0.0%

Jun 26 5:00 PM EST

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To: sammaster who wrote (781)	1/17/2006 12:47:31 AM
From: DewDiligence_on_SI	Read Replies (1) of 946

A trial can be designed to show superiority, non-inferiority, or either, but the statistical tests must be predefined and there is no “free lunch.” I.e., if you want to have a crack at either superiority or non-inferiority, the p-value threshold for each of these is tighter than if the trial aims to show only superiority or only non-inferiority. CTIC’s Xyotax trial in NSLC did not allocate any p-value to a claim of non-inferiority: it was a full-fledged superiority trial. In such a trial, allowing a post hoc claim of non-inferiority would be tantamount to granting extra p-value—a statistical no-no. CTIC misled investors about these details, and this (IMHO) is one reason that certain directors wanted Bianco removed.

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