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Vertex Pharmaceuticals Incorporated Message Board

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  • thirdmeinvestor thirdmeinvestor Sep 10, 2007 9:20 PM Flag

    Notes from the Bear Stearns webcast:

    Are you not aware of the fact that TVR rash begins around 8th week of TVR dosing and gets worse for these patients having severe rash? A triple:SOC treatment time of 8:12wks or 10:12wks should be allowed to those who achieve UND by week 4 (strict RVR) because relapse for this group is so rare.
    If FDA approves such a shortened protocol rather than a longer one, an NDA can be submitted as early as January 2009 because it takes only 1 year to complete Phase III (for the 48wk control the Phase II result can be used).
    VRTX has obvious incentive to work for 12:12 and/or 8:12 protocols for Phase III.

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