VRTX-Forbes.
Why is it Forbes always tends to support "pump?"
In our opinion, this new trial design alleviates a major risk factor for the VX-950 program," McMinn wrote Wednesday in a note to investors.
If anything this "proposed" extension arm will address whether or not VRTX's nuke will yield any side effects or toxicities. Yes, it has been added to address the aforementioned concerns.
I do believe VRTX and the FDA arrived at a "mutual agreement" this would be in the best interest for the development program, because there are still "safety-unknowns" regarding this compound. Best to find out now in Phase II before launching pivotals.
"Our primary concern with VX-950 has been that 12 weeks of dosing may generate a less than optimal sustained virologic response rate."
Oh really Rachel? What spin! Ahhhhhh! So the 12 week data generated thus far is likely NOT yielding SVRs. Oh my VRTX really needs to add that arm now, they need SRV and they so desperately need to prove safety in the 24 week arm too!
the worst-case scenario would be for Vertex to wait for full 24-week data with a Phase III start at the end of 2007, and a launch in 2010
Wrong again Rachel, the worst case scenario will be safety and toxicity issues emerging from the 24 week arm, ultimately sending VRTX back to the blackboard with a refined dosing regimen. All physicians will be keeping a very close eye on this arm.
katie.....
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