Thursday, August 03, 2006 6:49:31 PM
I am of the opinion that 6mg dosing results will not be spectacular nor do I think they were expected to delivery anything close to a cure as some have speculated.
The 1a data does not support a theory that 6 mg/kg will deliver efficacy much beyond that of lower dose cohorts. For example the 1.0 mg/kg cohort had a dosage level 900% greater than the lowest cohort at 0.1 mg yet only provided efficacy that was 50% greater when considering the number of patients above .6 log. The June 7 PR lumped results of 1.0 mg and 3.0 mg (a 200% difference in dosage amount) together suggesting relatively little difference and perhaps overlapping efficacy results. IMO another 100% increase in dosage will not have a tremendous increase in efficacy but any addtional increase (and I do expect some but not much) would be good news. I suspect the sustained response number could be a little better at 6mg.
On the same note I wonder if the 1a results are the big chunk of efficacy expected for multi dosing. Multi dosing should augment efficacy of the single dosing but it is possible given the moa that 1a was spectacular in achieving its effect on hcv without need of multi-dosing. In other words, greater dosage and multi-dosing may only modestly enhance results. The stock price seems to back this theory. Possible leaks of initial 1a dosing results at 0.1mg represents the bulk of the good news to date and coincides with a dramatic lift in stock price back in Jan/Feb. Subsequent analysis of higher dose cohorts did not yield dramatically different efficacy (still very good though. The results of 6mg may be leaking and are not showing any additional excitement. I also note Godofsky is quoted saying Bavi "should complement both existing and investigational thearpies..." He does not hint at a monotherapy cure. King is also talking combo trials.
Despite my attempt to throttle back expectations its evident that Bavi is working which provides lots of excitement for its many indications.
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