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jq1234

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jq1234

Re: iwfal post# 109599

Monday, 11/29/2010 8:50:19 PM

Monday, November 29, 2010 8:50:19 PM

Post# of 257302

Does the FDA accept RDTs as a pivotal trial?



No, FDA doesn't accept RDT as pivotal trial because RDT is exploratory trial. However, FDA does accept certain cohort from RDT trial in support of pivotal trial in NDA submission. Nexavar RCC cohort was used as part of Nexavar NDA along with a pivotal trial in RCC.
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