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Exelixis, Inc. Message Board

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  • erniewerner erniewerner Jan 15, 2011 6:41 PM Flag

    EXEL is one IND and one fasttracker away form 3 Billion.

    <<I'll also note that despite an SPA, ipilumumab required a randomized survival trial to likely get FDA approval. The single arm trial by itself would not do it.>>

    The Ipi SPA specified that the lower limit of the 95% conf interval needed to exceed 10%. Essentially, Ipi needed to show a 15% RR and the trial showed a 9% RR. It wasn't a question of FDA reneging on the SPA, it was the drug not meeting the endpoint.

    <<This data will need to be in the proposed population (I would think at least post-docetaxel)...>>

    The signal (at EORTC) was so strong in pain symptomatic patients, that I think they would want to go with this as a first indication. It also counters the issue of questionable "benefit to the patient" of an improvement in bone scan if you have a fallback argument that you can also show a statsig improvement in pain. Then run an 800 patient Abiraterone +/- Cabo frontline trial with a survival endpoint.

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