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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (179)	9/24/2002 2:42:56 PM
From: Vector1	Read Replies (1) \| Respond to of 447

The rec from the briefing materials. Really a punt> 10.1 Recommendation The Medical Officer defers making a final recommendation on approval until after the ODAC discussion and recommendation. Factors that will have to be considered by ODAC include 1) the 11 percent response rate observed in Trial 39 patients and in Caucasian patients in Trial 16; 2) the difficulty in interpreting quality of life/symptom relief data in phase II trials; 3) the uncertain effect of concomitant medication on symptom and quality of life improvement; 4) the characteristics of the responding patient population, (largely comprised of individuals with slow growing, less biologically aggressive tumors) and 5) the results of the two recently completed phase III first-line NSCLC ZD1839 trials that unequivocally failed to demonstrate clinical benefit