GOFISH..PGS...VRTX/IDIX
+++think VRTX is moving to the front of the pack on hep c. A few weeks of treatment including VX-950 followed by a few months more of pegifn + riba that results in SVR rates of 80 or 90 % in gen 1 patients would capture the naive markets in the U.S and Europe, IMO.
I certainly do not disagree there, however, PGS makes a profound statement regarding AE and SAEs, VRTX's data is on less than 20 patients, not a large patient pool at all for Boger to declare this is the new remedy for HCV, although I think the supporting data is most intriguing and I find it encouraging the FDA allows VRTX to move forward in an aggressive Phase II protocol based on the limited patient count.
+++I think this is very important if it holds up in larger trials.
I concur. If it holds up statistically in this expanded Phase II protocol then VRTX IMO is a very strong buy. The FDA is going to need data on at least 1k-2k patients before granting approval. The question is what type of approval is VRTX aiming for....accelerated or traditional. My guess is accelerated given guidance recently stated by the company, they didn't come right out and state accelerated, however in viral indications if Phase II supports dosing, and pivotal 24 week data is available the FDA can or will consider accelerated approval. In order for VRTX to gain traditional approval, they will have to complete two pivotals over a 48 week span.
katie....