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Vertex Pharmaceuticals Incorporated Message Board

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  • thirdmeinvestor thirdmeinvestor Apr 22, 2008 11:05 AM Flag

    Question for board

    The following Q & A about PROVE 3 data (from yesterday's cc) should help you.

    Karim Defillipe - Citigroup

    Hi, this is Karim Defillipe I’m just filling in for Yaron Werber, but thanks for taking my question. In regards to the PROVE 3, what interim data exactly do you expect to submit to the regulatory authorities in May and could you elaborate, perhaps a little more, what the next steps would be, when we would see that data and also, the possibility of PROVE 3 serving at the second registration trial? Thank you.

    Joshua Boger Ph.D.

    The key data in the interim trial are the SVR 12 results in the two 24 week arms in PROVE 3, including in particular the 12+12 regiment in that study. That interim analysis will be completed and submitted in May and we’ll talk further in terms of specific registration paths or how we would move forward from there after we’ve had our initial set of discussions with the regulatory authorities; the focus of which will clearly be as the first set of data that they will have seen in this particularly hard to treat patient population to get a full understanding of the data and the implications of the data.

    Karim Defillipe - Citigroup

    Great, thanks very much.

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