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Exelixis, Inc. Message Board

erniewerner 4 posts  |  Last Activity: Sep 2, 2014 7:29 AM Member since: Jan 18, 2000
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  • Reply to

    calling oncodoc02138....

    by semanresu Sep 2, 2014 5:32 AM
    erniewerner erniewerner Sep 2, 2014 7:29 AM Flag

    "While I am disappointed, this merely represents the crazy world of biotech investing. I never invest more than I am willing to lose."

    It's going to be an ugly day. I will not be surprised to see it settle out around $1.50. The Comet result is very much in line with prior results for Nexavar and Sutent, two other dirty VEGF TKI's that failed CRPC trials I think this means that the bone effects of Cabo are fleeting at best and perhaps somewhat illusory. For the near term that leaves the Meteor trial in RCC. With a PFS endpoint, this will hopefully have a better outcome. Cabo demonstrated very good PFS data in the EXAM trial and now again in the Comet trial. To say the least, very disappointing.

  • Reply to

    COMET-1 has 89.8% chances of failing

    by socialdiocies Aug 28, 2014 11:19 AM
    erniewerner erniewerner Aug 31, 2014 6:57 PM Flag

    "Irregardless of the timeline issue..."

    How open are you reconsidering the timeline issue?

  • Reply to

    EXEL presence at ESMO

    by wilderguide Aug 8, 2014 5:16 PM
    erniewerner erniewerner Aug 26, 2014 9:54 AM Flag

    "The HR for enzalutamide is 0.63. If EXEL beats enzalutamide with 960 patients, the study will not reach 578 events."

    You are all over the map and everywhere except where you should be. The trial already reached 387 events at a time point prior to the 3/25 press release. I am 99% certain that the 578 patient trigger has been reached since then. We are just waiting on the CRO, DSMB and EXEL management to finish and announce the result of the final analysis.

  • erniewerner erniewerner Aug 25, 2014 9:23 PM Flag

    "the November data probably will show a good chance of any benefit.."

    The first cohort showed a statistically significant improvement in a number of NASH associated parameters as compared to baseline measurements and the 2 placebo patients. The 2nd cohort actually did worse than placebo. The dosage for the first cohort was at a drug concentration that was less than that found to be active in the animal models (mice and rats).

    I look at the present circumstance and the only conclusion I can come to is that the sample size (6 treatment 2 placebo) is too small, the measured parameters too variable, and the trial duration too short to draw any meaningful conclusions regarding activity and efficacy. The euphoric rise in the pps following the first cohort was overdone. We will see what happens with the third group, but even if the parameters return to a positive trend, I would expect the market to regard any outcome with a bit more caution than the first time around.

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