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AVEO Pharmaceuticals, Inc. Message Board

  • arodbronx arodbronx Dec 27, 2012 7:46 PM Flag

    February 16th

    Watch for the February 16th Genitourinary Cancers Symposium, abstracts 350, 354, 355, 361, and 364. This is were the additional analyses provided by the company to the FDA regarding the OS question will be published for the first time.

    You heard it here first. There is ZERO chance Tivozanib is not approved for RCC.

    Sentiment: Strong Buy

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    • You said in an earlier post that the data will be the "same" like the originally reported. And you wrote that management indicated that it won't be much different. So to mee it looks like this presentation will have a negative impact on the share price. The guy from the Seekin Alpha article expects good news. I don't know why? I still didn't understand the following point: Are they going to present the actual numbers of the crossover patients? So we can see exactly which crossover patients reached which OS?

      Sentiment: Buy

      • 2 Replies to shushkin_ch
      • sushkin,

        Ignore the shills posting on Seeking Alpha. Do your own DD. Learn how to read SEC filings. From p. 25 of AVEO's 10-Q filed 11/08/12:

        "Based on early, interim analysis of overall survival at one year after last patient enrolled, 81% of patients receiving Nexavar achieved one year
        overall survival and 77% of patients receiving tivozanib achieved one year overall survival. In the TIVO-1 study, 53% of all patients randomized
        to the Nexavar arm of the study went on to receive a subsequent cancer therapy after their disease progressed, nearly all of whom received
        tivozanib after Nexavar. In comparison, only 17% of all patients randomized to tivozanib went on to receive a subsequent therapy. An analysis of
        overall survival at 24 months since last patient enrolled, which is considered final overall survival data per the protocol, was included in our New
        Drug Application, or NDA, submission. Such data were not materially different from the data at one year and will be discussed at a medical
        meeting in the future."

        So you can see, management clearly states the OS data at the 24 month protocol defined cut-off is not materially different from the 12 month data it originally released. If the Seeking Alpha author believes otherwise, he's in for a rude awakening.

        Fortunately, it's not going to matter. What most of the #$%$ obsessed with the OS data don't understand is the trial was never statistically designed, due to the cross-over factor and immaturity of OS data at time of capture, to accurately portray the statistical significance of the OS. One of the few posters to understand this and post on it is enrjrr. Read over his past posts. So while the OS results are counterintuitive, they are statistically irrelevant and easily explained away by the cross-over design.

        Tivozanib is an active agent with a favorable safety profile. The FDA is going to approve it.

        Sentiment: Strong Buy

      • All of these points are correct. There have been statements by senior management as well as Investor Relations that the survival data is still showing a trend favoring sorafenib. While the numbers have not been announced yet, the margin is expected to be similar to the original analyses.

        Importantly, statisticians and oncologists will appreciate the fact that the p-value for the overall survival results in TIVO-1 is NOT significant. The p-value was also not significant in the original presentation at ASCO. In statistical terms, this means that you cannot rule the finding (survival benefit better for sorafenib) with a high level of certainty. Another way of explaining a lack of statistical significance is that the outcome was just as likely "by chance" - as opposed to a causative relationship between the two variables. Bottom line, the survival numbers favoring sorafenib are there - but are weak statistically. This will be a key point that the ODAC committee with see as a positive for approval of tivozanib.

 
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