Why did KM use the terms "spectacular" and "illuminating" in the weeks before ICAD?
Perhaps because KM saw some charts that weren't shown at ICAD. So I've generated some charts that show how individual bapineuzumab dosages compare to placebo on each of the four endpoints, using data that is in the presentation, but that isn't highlighted.
Here they are:
There are, of course, caveats regarding statistical significance, since the number of patients at each particular dosage level is small (sometimes only 8 or 9, or fewer---we're not told exactly). And I've made linear interpolations (averages) between week 0 and week 78, since those were the only two weeks given for the individual dosages. And in the case of the completer cohort, I've had to assume that the completer placebo patients scored about the same as the MITT placebo cohort patients. (Elan: give us more details!)
So there's lots of room for nitpicking. And these charts surely make one puzzle over the fact that the dosage level of 1.0mg/kg works so miserably across all of the tests. What's going on with that?
But look at the bap dosage level of 0.5mg/kg in these charts (the green line). I find those results both spectacular and illuminating, and I can surely see why a Phase III trial is justified. If the results of the 0.5 dosage are verified in Phase III, it'll be incredibly exciting: in the non-carrier completer cohort, as you can plainly see from the charts, the mental decline is not only halted, it is reversed!
Two other sets of charts would also of interest, of course: the carrier MITT cohort and the carrier completer cohort. I hope to get a chance to generate those charts sometime soon. They won't be nearly as spectacular, but they might be interesting.