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mskatiescarletohara

04/15/07 4:46 PM

#865 RE: DewDiligence #862

Anyone have any comments on McHutchison's comments referencing VRTX's compound. Shortening length of treatment is HUGE, quite an endorsement from McHutchison.

"The high rates of RVR observed in the telaprevir groups in PROVE 1, and the fact that some patients have remained persistently viral negative 20 weeks after stopping the 12 weeks of telaprevir-based therapy, suggest that we may be able to shorten the treatment duration in genotype 1 HCV patients," said John McHutchison, M.D., Principal Investigator for the PROVE 1 study and Director of Gastroenterology and Hepatology Research at Duke Clinical Research Institute. "These interim results are encouraging and suggest that high sustained viral response (SVR) rates may be achieved with regimens that are 24 weeks in total duration. We look forward to 24 week follow-up data from the initial group of patients who stopped treatment at 12 weeks, and follow-up data from patients in the study who received 24 weeks of treatment."



katie...
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mskatiescarletohara

04/15/07 4:51 PM

#867 RE: DewDiligence #862

that VRTX could obtain accelerated approval for VX-950 based on only the phase-2 program.

I've always felt they would use the 24 week data from the pivotals, along with data from the Phase II program. Especially now, that McHutchison has projected treatment can be shortened in some patients. Looks like early 2009 will be potential marketing approval.

katie...