re nm-283 phase III delay
there is no argument that the cumulative delay is significant. What my contention is is merely that going into the JPM conference we already knew what most if not all of these delays were, and that no significant new delay was announced save for perhaps spelling out what might have been already deduced from the information available before Jan 9th. Specifically, we knew phase III discussions were predicated upon results of drug interaction study which is due Q1. So FDA discussions would by necessity occur end Q1 but more realistically Q2, with initiation ph III end Q2 at best but more reasonably Q3. Put another way, if you had polled this board before Jan 9th as to timing of phase III and someone would have responded "early 2007" I would have questioned that regardless of what may have been said in a presentation last year simply based on the logic above. This is why 2H2007 didn't come out of left field for me, but I acknowledge and defer to your experience insofar as your contention of 2H2007 generally equates to Q4, and based on the above timiing this does imply an added delay of 1 quarter..moreover, i am not dismissing even one quarter delay as meaningless, particularly on top of the delays you already mentioned, but then again we still need to see if 2H2007 means october or december)
so basically i am agreeing with you 100%, except your reaction to the jan 9th conference specifically i found curious, as your very well founded misgiving re timing of phase III was known (more or less save maybe one quarter) before this conference..in fact another poster ruminated months ago on how nm-283 once had at least a year's jump on vx-950 which had now all but evaporated.. in fact vrtx placed phase III for vx-950 end 2007 jsut recently, so I'm not the only one who had this sort of time-frame (i.e mroe or less when vx-950's phase III was due to enroll) already factored in..
there is no argument that the cumulative delay is significant. What my contention is is merely that going into the JPM conference we already knew what most if not all of these delays were, and that no significant new delay was announced save for perhaps spelling out what might have been already deduced from the information available before Jan 9th. Specifically, we knew phase III discussions were predicated upon results of drug interaction study which is due Q1. So FDA discussions would by necessity occur end Q1 but more realistically Q2, with initiation ph III end Q2 at best but more reasonably Q3. Put another way, if you had polled this board before Jan 9th as to timing of phase III and someone would have responded "early 2007" I would have questioned that regardless of what may have been said in a presentation last year simply based on the logic above. This is why 2H2007 didn't come out of left field for me, but I acknowledge and defer to your experience insofar as your contention of 2H2007 generally equates to Q4, and based on the above timiing this does imply an added delay of 1 quarter..moreover, i am not dismissing even one quarter delay as meaningless, particularly on top of the delays you already mentioned, but then again we still need to see if 2H2007 means october or december)
so basically i am agreeing with you 100%, except your reaction to the jan 9th conference specifically i found curious, as your very well founded misgiving re timing of phase III was known (more or less save maybe one quarter) before this conference..in fact another poster ruminated months ago on how nm-283 once had at least a year's jump on vx-950 which had now all but evaporated.. in fact vrtx placed phase III for vx-950 end 2007 jsut recently, so I'm not the only one who had this sort of time-frame (i.e mroe or less when vx-950's phase III was due to enroll) already factored in..
