The statistical review is all I have time to read, but mostly the data we had stands up, and it looks on balance persuasive that there is benefit.
Question on 3.2 (page 36)
Anyone comment on the contradiction: it states that DNDN planned to use (for 02a) the same set of covariates "before they looked at the data" ........... a few lines later it says "given the fact that the data were available at the time the sponsor developed an analysis plan" ........
In one CC, Gold said that survival was added as an endpoint while still blinded.