Odac Case Analysis

Satisfactory Essays
ODAC recommended not to approve in December 2009, based on perceived flaws in the SATURN trial submitted for approval, including the primary endpoint stated as PFS, the modest effect on OS observed, the lack of a 2nd confirmatory trial and questionable design. FDA Director Robert Justice later indicated FDA agreed that an ideal design would have compared early erlotinib with erlotinib at progression, but that FDA believed the submitted design was
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