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Tuesday, February 16, 2016 12:31:10 PM
CP, thanks. First, just want to remind everyone this is all speculation....
Yes.
Anyway, the question is why do we have this disconnect between models applied to both arms, and the real time timing of the first look.
Both CP and trader seam to have reasonable models. But if they apply them to both arms them the first look would have been many months ago. And that is the conundrum.
A 20 month MOS for bavi would be great, but that would not be enough to explain the issue. The candidates are :
. Placebo arm doing better than guessed
. Enrolment way "backloaded"
. First look already triggered and awaiting rec from DSMB
. Dropouts (or just slow event data collection) in the E-EU sites
. Rumsfield's "the unknown unknowns".
I would guess some of all.
One number I will toss out. Anybody who thinks the first looks is likely to show better than 40 vs 110 events is really reaching. 60 vs 90 would great, 50 vs 100 would be off the charts.
Of course, we might never know. They will PR "trial continues" shortly (IMO).
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