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Re: None

Saturday, 09/01/2007 2:41:13 PM

Saturday, September 01, 2007 2:41:13 PM

Post# of 12660
The Cancer Vaccine Consortium's Annual meeting will be held in Bethesda, Maryland at the end of September. See: http://www.sabin.org/files/PDF/CVC2007_preliminary_program.pdf

Given the multitude of scientific conferences held each year, the importance of many is merely in networking. Given the list of speakers, CBER regulators, competitive regulated companies, the NCI, including its seeming point man for cancer vaccines, Dr. Schlom, the May CRL for Provenge, upcoming Phase 3 results for MEDX/BMY's ipilimumab, and interim Phase 3 results for Provenge and GVAX in 2008, this one may be different. The scheduled speaker for DNDN's presentation on The Sipuleucel-T Experience is Elizabeth Smith, the capable overall "emcee" for the Provenge AC meeting, but not a doc or scientist as far as I know. It should be an interesting challenge for her wrt how best to summarize the regulatory experience without discussing in more detail the unpublished CRL and Form 483, in the presence of CBER officials no less.

There are also some presentations concerning FDA approvals of combination therapies, which may bring into better perspective the comments of the NCI's Dr. Niederhuber, that the first immunotherapies to receive FDA approval will be combinations and whether this ultimately will be how both Provenge and GVAX receive initial FDA approval.
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