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Biotech / Medical : Biotech Short Candidates

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To: Icebrg who wrote (591)10/20/2003 11:17:32 AM
From: tuck  Read Replies (2) of 897
 
Off the top of my head, I would say it has some significance, because one of the other two trials involve combination of XYOTAX with other chemo drugs in PS2 patients. We'd have to go dig up the PII data for survival at MTD (I chucked my notes on this and would have to find it again). The quoted PR does show a survival benefit from the 175mg dose, so it is not an utter disaster at this point, but one wonders if the other PS2 trials will have similar issues. I don't know if this would cause "discussions" with the FDA, given that CTIC now appears to be gunning for greater safety versus the comparator arm at the cost of some efficacy on the survival benefit. I would think so, and that would slow down its time to market, at least. I can't remember how well the 175mg survival benefit of 22 weeks corresponds to other 2nd generation taxanes (APPI's, for example, would be worth watching) or to other therapies in similar stages of development.

What do you think? It appears you've started to look at CTIC recently.

Cheers, Tuck
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