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Biotech / Medical : Cell Therapeutics (CTIC)
CTIC 9.0900.0%Jun 26 5:00 PM EST

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To: tuck who wrote (591)3/10/2005 4:33:56 PM
From: Rudy Saucillo   of 946
 
>>I'm not sure how common that doublet is now.<<

From the literature it appears that paclitaxel and cisplatin (a platinum) is a fairly common doublet in front-line NSCLC, especially with brain mets.

I can understand why front-line patients treated with docetaxel were excluded (for the same reasons that any patients previously treated with PEG paclitaxel were excluded). It wouldn't be ethical to randomize a patient who previously failed docetaxel to a docetaxel arm (and the FDA wouldn't see that patient as a representative comparator to patients in the PEG paclitaxel arm). That certainly increases the hurdle for Xyo, IMO. Let's hope the SPA revision to include non-inferiority as a primary endpoint is approved.
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