PROVE-1: --160 patients (of planned 260) already screened --3Q06: enrollment complete --4Q06: initial data from 12-week arms --1Q07: 3-mo post-treatment data from 12-week arms --2Q07: 3-mo post-treatment data from 24-week arms and 6-mo (SVR) post-treatment data from 12-week arms
PROVE-2: --Each milestone will trail the corresponding one for PROVE-1 (above) by approximately one quarter
PROVE-3 phase-2b study in treatment-refractory patients
--Design has not yet been fully specified but (unlike PROVE-1/PROVE-2) it will definitely include some treatment arms that receive 24 weeks of VX-950 --Launch in 4Q06 upon completion and analysis of 6-mo tox studies in two species that started in March
Manufacturing
--First registration lot will be produced by end 2006 --1-yr stability data on required three lots ready in time for 2008 NDA submission
Phase-3 and NDA submission
--Start phase-3 in mid 2007; if based on phase-3, NDA submission will be in 2008 (no change from prior guidance) --Obviously, VRTX hopes to submit an NDA based on data from phase-2b, but they cannot make this their official guidance
Competition
--Confirmed rumor that BMY PI program has been canned (#msg-12052181) --SGP PI program has hit a setback with dosing; patients who were receiving less than the 800mg dose have been upped to 800mg
Dosing frequency and pricing
--There are no plans to make BID dosing part of the initial indication --If it turns out that VX-950 can be dosed BID because of boosting by ritonavir (or another compound), VRTX will price accordingly even though BID dosing will not initially be in the label
News flow
--AASLD in Oct will not have any data from the PROVE trials, but it will have final data from phase-1b
Market Data 
Markets 
AI
