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steveporsche

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steveporsche

Re: mcbio post# 111246

Wednesday, 12/22/2010 12:03:34 AM

Wednesday, December 22, 2010 12:03:34 AM

Post# of 252190
EXEL - Some reading for you:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm182443.htm

There are other documents more specific to HRPC in general, but it would take me a while to find. There was a FDA Prostate Cancer Workshop pre-Impact results (and follow-up publication shortly post Impact results) discussing the suitability of various endpoints in HRPC. It has been a long while since I looked at this stuff. They better have a SPA for the P3 as Pazdur wants survival as the primary.
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