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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”