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Re: p3analyze post# 47003

Saturday, 05/19/2007 6:51:51 PM

Saturday, May 19, 2007 6:51:51 PM

Post# of 253120
>laughable statement. QOL measures the symptomatic, physical, psychological wellbeing and social functioning, whereas TTP measures the radiological component. Gemzar did not improve QOL so its label does not allow such a claim.<

Who cares whether or not Gemzar has explicit QoL improvement on the label? It has lengthened progression-free survival on the label; for the reasons I’ve mentioned, this is tantamount to a QoL benefit. Whether you want to acknowledge it or not, the implicit QoL benefit is one of the reasons the FDA granted approval based on PFS. Moreover, the implicit QoL benefit is one of the compelling arguments that led to LLY’s submitting the Gemzar ovarian NDA in the first place. (If you don’t believe this, call LLY and ask.)

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As an aside, I note that some of your assertions regarding Provenge and related topics strike me as delusional. For instance, you once posted that PGS and I were depriving DNDN of needed capital. My advice to you is to lose the emotionalism that seems to pervade some of your posts on this subject.

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