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AVEO Pharmaceuticals, Inc. Message Board

  • shushkin_ch shushkin_ch Dec 20, 2012 10:16 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!
    shush

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    • 1. Is it true that Aveo already submitted additional OS data to the FDA? Or are they planning to submit more data?

      OS data was included in the NDA. The cut-off point was 24 months from the day the final patient was enrolled so it ran through the end of August 2012. This cut-off point was pre-specified in the trial protocol.

      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?

      Management stipulated in its October 30th conference call that OS and other data would be submitted to the 2013 ASCO Genitourinary Cancers Symposium in February. This data should clear up many questions and yes it should have an impact on share price.

      3. What's the latest time point where the FDA has to inform that there will be an ODAC meeting?

      Don't know the answer to that (assuming an ODAC will be required).

      Sentiment: Strong Buy

    • Can you provide a link to the 2013 ASCO-GU abstracts?

 
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