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stranger
Guest
http://investors.vrtx.com/releasedetail.cfm?ReleaseID=687394
con call begins at 8am ET!
con call begins at 8am ET!
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semperfiohana
Guest
"Based on these data, Vertex plans to conduct additional clinical studies of VX-809 and KALYDECO in heterozygous patients. "
that's in the article, but until they release what goes on today in the conference i don't think we will know for sure.
that's in the article, but until they release what goes on today in the conference i don't think we will know for sure.
Aboveallislove
Super Moderator
Yes, Vertex is moving to Phase 3 for homo, predict in early 2013. Further study in heter. Here's the press release again and you can listen to the recorded conference via telephone as noted in the press release. http://investors.vrtx.com/releasedetail.cfm?ReleaseID=687394Or go to vrtx.com and go to events and presentations and click on the achieved one for today.
The market is responding negatively b/c Vertex didn't provide comparable data to interim--only 600 arm not pooled and results for 600 were basically the same as pooled compared to placebo and higher compared to baseline. I say "who cares," they are moving forward with 600 (and possibly higher--if FDA allows, or if not a quick Phase 2b on higher doses prior to adding an arm at higher in Phase 3), so I'm not concerned re the pooled response. Also, the responder analysis for 600 is higher than before. Not the knock-out VX770 was, but getting there.
The market is responding negatively b/c Vertex didn't provide comparable data to interim--only 600 arm not pooled and results for 600 were basically the same as pooled compared to placebo and higher compared to baseline. I say "who cares," they are moving forward with 600 (and possibly higher--if FDA allows, or if not a quick Phase 2b on higher doses prior to adding an arm at higher in Phase 3), so I'm not concerned re the pooled response. Also, the responder analysis for 600 is higher than before. Not the knock-out VX770 was, but getting there.
musclemania70
New member
Phase 3 to start in 2013.
Aboveallislove
Super Moderator
Good summary posted by someone on yahoo.com message board for vrtx
livinglovinggrace
New member
The reason phase 3 isn't starting until next year is that there is going to be a stage 3 for phase 2.