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Exelixis, Inc. Message Board

  • erniewerner erniewerner Dec 11, 2012 4:47 PM Flag

    Dr. Schwab on Comet 2 as a Standalone

    Gisela M. Schwab - Executive Vice President and Chief Medical Officer
    Regarding the question of whether we would file with ‘306 alone, I think the data providing, if the data are warranting it we could go forward in our view with ‘306 alone as we view it as a standalone study and then subsequent with the ‘307 trial when the data is available.
    Imran Badar - Cowen and Company
    Okay. Great, great and I guess, the second question is, I’m wondering if you comment a little bit more about Europe and Europe’s view on pain and potentially talk about their perspective in contrast to that in the US?
    Gisela M. Schwab - Executive Vice President and Chief Medical Officer
    So, we’ve gone through scientific, central scientific advise at the EMEA and that is a very rigorous process as I’m sure you’re aware provided the protocol is being reviewed and the analysis plans a whole are reviewed and very detailed feedback is provided and we’ve received a favorable feedback regarding pain end point and the way we are collecting the information and the way we are intending to analyze the information and end point definition. So, clearly that was positively received and I think regarding the specifics around pain endpoint definition and collection of data and analysis plans, there is no difference really regarding the pain endpoint between the feedback received from the EMEA and FDA.

 
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