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Re: DewDiligence post# 86819

Sunday, 01/10/2010 7:58:05 PM

Sunday, January 10, 2010 7:58:05 PM

Post# of 257253
Three small timeline slippages for Telaprevir:

http://finance.yahoo.com/news/Vertex-Reviews-2010-Business-bw-37981228.html?x=0&.v=1

1. VRTX now expects to report SVR data from the phase-3 ILLUMINATE trial in the first-line setting in 3Q10; the old guidance was 1H10. VRTX has not changed the guidance for reporting SVR data from the other first-line phase-3 trial called ADVANCE, nor has it changed the guidance for an NDA submission in 4Q10.

2. VRTX now expects to report SVR data from the phase-3 REALIZE trial in the second-line setting in 3Q10; the old guidance was “mid 2010.” (A single NDA submission in 4Q10 will be made for both the first- and second-line settings.)

3. VRTX now expects to start a phase-2 trial of Telaprevir ± VX-222 in 1Q10; the old guidance was 4Q09.


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