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iwfal

02/23/11 11:34 AM

#115352 RE: jq1234 #115351

EXEL -

It is possible {to have the FDA approve a cancer SPA for an endpoint that is neither a well established surrogate endpoint nor a unambiguously an important clinical endpoint} in the context of a separate companion trial with survival endpoint.



I cannot think of nor find a single example of such a thing happening in cancer. Not one. Hence my question to the board to ask if anyone knows of such an SPA - if there continues to be silence I think that indicates that XL184 would be a first and that hugely lowers the odds that EXEL will succeed in getting one.