"..more often than not, guidance of 2H means 4Q. (If a company expects a positive event to occur in 3Q, they generally say 3Q rather than 2H.."
well on the surface 2H2007 didn't come as any curveball to me, but my inexperience may be showing regarding reading into the nuances of the guidance..truth is i never really had a hard preconceived target date in mind, but loosely speaking we all knew exactly when data from drug interaction study would be due (end Q1), which truly is a prerequisite to phase III design, followed by some analysis and discussion of design of phase III with a notoriously slow burocratic agency (QII, so i never would have thought a phase III would get off the ground until 3rd quarter earliest..i also don't think the FDA, despite all the focus on this illness, is in such a rush to hurry through registration trials in naives - the truly unmet need is in refractory setting, so its not like a meeting and agreement on design is going to happen overnight - this is just my opinion. i also got the feeling from the vrtx slides (have not listened to webcast) that they are more or less on similar timeframe, with the notable advantage that they have prove-3 which in and of itself migh tmerit approval based on results, again due to the pressing unmet medical need of this tx population (oh yeah, vx-950 has also shown higher und rates - we'll see what their svrs are soon enough)
the real delay was initiating the drug interaction study..not sure if idix was trying to push a non-riba containing registration trial and/or soc consolidation and FDA insisted on a riba-arm with nm-283, or someone jsut wasn't farsighted enough to have the appropriate animal safety data in place, but something threw the initial guidance off..but this was something we already knew, and if there was an added few months delay based on today's cc it went right over my head (but of course that is one reason I am on this board!)
I'm guessing your true negative vibe is more the tyzeka guidance, which ironically may result in a bump in share price given it is double at least one analyst's guidance..personally i might have hoped 15-20M/quarter by year end as well, but a trajectory towards 100M in 2008 still isn't all that bad i would think
so all in all i just didn't feel there were too many surprises today..would have loved nm-283 clarification in refractory setting - didn't get it, but also i drew some positive from JP's excitement on their HIV candidate(s), which ratcheted up my hopes for positive Ib data this year (which in a resistant HIV strain would be pretty big news)..although perhaps the HIV thing was a smoke screen for some deficiencies/delays in the hep program (which if they were there were fairly subtle)
see, now you have me thinking..!
AI
