Replies to post #27867 on Biotech Values

[DewDiligence]

> VRTX – This data was new: "Researchers reported for the first time today that 8 of 8 patients who received VX-950 and peg-IFN in combination for 14 days have no detectable virus in their blood at the end of 12 additional weeks of peg-IFN+RBV dosing"<

Correct—these 2-weeks-on-2-weeks-off data go beyond the 2-week-on data reported by VRTX in January. But how much more superlative can you get than superlative? If VX-950 has an Achilles heel, it is obviously not the efficacy. That’s why I said today’s PR doesn’t materially alter the competitive landscape, in my opinion.

>…I think this data will make a splash , and it may explain some of IDIX' recent weakness.<

No question on the first part of your sentence, but I’m not sure I agree on the second part. As an IDIX shareholder I’m more concerned about NM283’s own data than I am about VX-950’s.

It helps that NM283 is further along in its development timeline than VX-950 is. This assures that NM-283 won’t have to go head-to-head against VX-950 in any registrational trials.

[mskatiescarletohara]

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....

[walldiver]

VRTX-The impressive efficacy of VX-950 isn't in question. It's been out there for awhile now about how well the drug clears the HCV viral load. The remaining question mark for VX-950 is safety, specifically the monkey toxicity studies, which have yet to be conducted.