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Re: nerdseeksblonde post# 1926

Thursday, 01/04/2007 4:17:05 PM

Thursday, January 04, 2007 4:17:05 PM

Post# of 12660
The immune assay to which you are referring is, I assume, the CD54 upregulation. This was prespecified in the trial design as a measurement of the patient's immune response/Provenge potency in the body. It turned out that the better the upregulation level, the longer the survival. Since DNDN can measure the CD54 upregulation in a patient's body immediately after reinfusion with the Provenge cassette, they can repeat the leukapheresis process for that particular visit if the upregulation level doesn't reach a certain threshold. This is an example of a metric that the FDA usually likes.
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