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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: Ian@SI who wrote (710)	7/6/2005 1:53:18 PM
From: tuck	Read Replies (1) \| Respond to of 946

Well, I must say, if the whole advance towards personalized medicine is going to be based on subset analyses, pre-specified or not, the FDA will soon have several opportunities to keep the advance going or slow it down. CTIC, LGND's Targretin, etc. Recalls the Chinese curse "May you live in interesting times." Cheers, Tuck

To: Ian@SI who wrote (710)	7/6/2005 2:27:31 PM
From: Clarksterh	Read Replies (2) \| Respond to of 946

In addition, in the first-line STELLAR 3 and 4 trials in poor performance status (PS2) patients, XYOTAX demonstrated a statistically significant increase in survival among women (198 patients total), with a 60 percent increase in 1-year survival. "The survival advantage seen in women in the STELLAR 3 and 4 studies is worthy of note. The trials were stratified by gender and survival by gender is pre-specified in the analysis plan," stated Scott C. Stromatt, M.D., Sr. Vice President of Clinical Development and Regulatory Affairs at CTI. "We plan to explore these results later this summer in our discussions with FDA regarding the regulatory submission for XYOTAX." If(!!!!) the effect is seen across all three Stellars (where is mention of Stellar 2 BTW) then they might have something. But Post Hoc analysis of two of the three trials is just not reliable. (And the mention of having it in the Analysis Plan is almost certainly meaningless - typically companies have 10's of things in there so the chance of finding 'positive' results on one is pretty good.) Your friendly neighborhood statistical pain in the butt. Clark