flatlander..now that you mention it i seem to remember NVS putting nm-283 in 2010 sort of time-frame..there may be a post or two about it on the bv board
What changed in the month following the investor lunch to push back the anticipated filing date
not sure..I think in general the path to approval for nm-283 is a tad muddled not so much because of concerns regarding efficacy, but what might be the best path to pursue in light of the more efficacious protease inhibitors and where nm-283 might fit in a treatment paradigm..just a hunch.
Is it likely that NM283 is being considered primarily for use in combination with protese inhibitors or albuferon..
possibly..i don't think even IDIX/NVS know for sure yet. I really think everything depends on the interaction study. if ribavirin gives a significant boost to efficacy then triple combo int-rib-nm will be pursued, and it may rival vx in efficacy or come close with altered side effect profile (no rash) that may appeal to some, with protease-polymerase regimens tinkered with post-marketing..if not great boost to efficacy, in light of vx idix may go for the niche of riba-intolerant patients and just go with non-inferiority (or superiority?) to soc with int-nm cotherapy without rib. the earlier start to their HIV/HCV coinfected population trial may also give them a leg up in this niche, but I don't think that will be a primary path to approval..so in a nutshell, and total speculation here, idix/nvs is awaiting drug interaction and perhaps to a lesser degree vx outcomes before deciding how/when phaseIIIs will be designed, and all of the above may be contributing to the delays seen thus far
I know you guys are pretty sharp on this subject
that is debatable (at least I can speak for myself!);)
Also, does anyone have more information on the senior VP who exited Idenix today?
none..not sure if you are intimating that perhaps the change in cmo has something to do with the nm delays - possibly, or perhaps it is just to refocus on HIV..who knows
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