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AVEO Pharmaceuticals, Inc. Message Board

  • shushkin_ch shushkin_ch Dec 20, 2012 10:02 AM Flag

    Doing some DD

    1. Is it true that Aveo already submitted additional OS data to the FDA? Or are they planning to submit more data?
    2. On February 16 there will be a poster session with abstracts from Aveo at the 2013 Genitourinary Cancers Symposium. I see 5 abstracts (350, 354, 355, 361, 364) with tivozanib. Abstract Nr. 350 is about Overall survival results. Does this mean that we will get results and answers to the crossover problem? Are these abstract going to have an impact on the PPS?
    Maybe I'm wrong on this, but why should the present data/results if they were bad?
    3. What's the latest time point where the FDA has to inform that there will be an ODAC meeting?

    Thanks in advance!

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    • Aveo has submitted to the FDA additional overall survival analyses as part of their FDA filing. This data is more up-to-date results and has yet to be presented at a scientific medical conference. CFO David Johnston stated on their recent call with Deutsche Bank that this data has been submitted to ASCO GU to be considered for poster or oral presentation. During this same presentation at DB, he referenced that the original trends that favored sorafenib appear to be consistent with the original presentation at ASCO. I spoke with investor relations and the continued overall survival trend favoring sorafenib in this updated result remains the same. Therefore, this presentation is not likely going to change much for the stock. However, Johnston offered an important point about the design of the study that appears to be lost on many investors. Aveo designed the TIVO-1 trial with crossover allowed. As many investors know, this decision is the primary reason that the survival numbers are inconsistent with the progression-free survival numbers. Some have questioned this decision by Aveo - and suggested that Aveo will need to conduct another RCC trial. Johnston shared that the investigators felt very strongly that RCC patients would only want to enroll on this trial if they could be guaranteed a chance to get tivozanib - either at the initial randomization or upon progression. Allowing crossover is the ONLY way to allow for this.

      As for the ODAC meeting, this event can occur 2-3 months from the PDUFA date (late July 2013) or as few as a couple of weeks before. Aveo management believes an ODAC meeting is highly likely - and the company views such a meeting as a potentially very positive event . I agree and believe that the findings of the ODAC committee will be the next catalyst for the stock. This committee always finds positives and negatives on every drug - and the interpretation of their findings can often create high volatility in biotech (see ONXX) but this will be a major positive for AVEO IMO. GLTA.

      • 1 Reply to enrjrr
      • Thank you for your informative post.

        Sorry for my bad english but it's no my mother tongue.
        But do I understand this correctly? If AVEO says that the OS difference is because of the crossover patients and they know the % numbers of people who switched, so they should explain this with the data of this "crossover patients"? But if you say "and the continued overall survival trend favoring sorafenib in this updated result remains the same" so it means that the difference in OS is not because of the crossover?

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