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Vertex Pharmaceuticals Incorporated Message Board

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  • thirdmeinvestor thirdmeinvestor Nov 3, 2011 5:32 PM Flag

    From VRUS's conference call

    They still have not shown the SVR % from the control (IFN/RBV) group in a double-blinded trial. How does the tough FDA allow phase 3 trials without seeing complete phase 2 data?

    They should treat null nonresponders and cirrhotic patients in double-blinded trials.

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    • >>They should treat null nonresponders and cirrhotic patients in double-blinded trials. <<

      I don't see Vertex testing nulls with it's VX222 regimen. Though I think they both should as that would show the biggest differentiation between treatments.

      As to VRUS, I think they will, they just haven't treated enough in phase II to decide what course to take. Note that the third phase III that treats G1 will take till mid 2012. They are obviously waiting for more data, More safety testing too.

      Another thing you people need to be concerned about is how quick these trials are. They are using SVR12 now instead of SVR24. None of these treatments will take more than 6 months plus SVR12.

      Vertex trials were 12 months plus SVR24. 18 months versus 9 now.

    • "How does the tough FDA allow phase 3 trials without seeing complete phase 2 data?"

      Are you suggesting they are not providing the FDA with phase 2 data from the control group?

      I've heard your argument on this before. The level efficacy demonstrated up to this point makes control group data hardly an issue. By the way VRUS has been running double-blind studies up till this point in time.

 
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