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Exelixis, Inc. Message Board

  • xwavve xwavve Apr 20, 2013 11:21 AM Flag

    Early COMET 2 Results?

    COMET 2 results may be guided early by EXELIXIS. The primary endpoint is a confirmed pain response at Week 12 durable since Week 6. Paitents are self-reporting information on pain and health-related quality of life via an interactive voice recognition system (interesting collection methodology).

    The original estimate was for around 240 patients, and it is likely recruitment is far ahead of schedule. The press regarding the efficacy of cabo is high, and patients and caregivers are well informed. The original completion date was guided for June 2014. It wouldn't be surprising for the trial to complete late fall of this year.

    It is possible that we'll here about this on May 7th.

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    • Because they go through a pretreatment pain medication normalization phase, the week 12 pain assessment actually occurs at week 15. It will be obvious when the trial has reached full enrollment, the 50+ participating centers will no longer be recruiting patents. When this occurs, antici[ate topline results about 7 months thereafter. Data cutoff for the EXAM trial was 6/15/2011 and topline results were announced 10/24. EXEL will need a comparable amount fo time to process the pain, bone scan and raiological data the Comet 2 trial requires.

    • The quarterly results always have included a pep talk about what Exel is doing and hope will happen down the road. If my memory is serving me well;I wouldn't expect anything different this time.

      • 1 Reply to clemcaldwell
      • $$$$
        Business as usual...with all the usual potential for some added transformational spice.
        OS data from the EXAM trial is the real sleeper here, and it could present at any time...
        With 43 trials on the collective Cabo plate, there are many that could lend early interim results...
        Additional Cabo MOA supportive data could also sustain some significant volume spiking...
        Barring negative surprises, the next 12 - 18 months are promising to rearrange the molecular structure of EXEL, and quite possibly turn it into either a successful venture...
        Or a BP trophy...

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