Biotech Values

[iwfal]

Hirogen - Thanks for this dialog. I know what they did (and it is always useful to figure out how companies game their PRs):

a) The interim analysis was done with exactly 228 events - exactly at the tigger number. No patients found during clean up were added. (you can tell this from the HR uncertainty boundaries released at the interim - when you reverse engineer them it is obvious no additional patients were added.)

b) But for the final they actually used 331 (not the 304 in the PR about the trigger) - and per their own AC material
it sounds like that was actually the design number. And THAT number correctly correlates to 88% power they touted with the correct final alpha.

I.e. the trigger for the final was 304 events but they had FDA permission to use patients events found or occurring during database clean up (i.e. prior to unblinding) up to 331 and that ups the power. Why they felt it necessary to play hide-the-truth I do not know - but based on the AC material, the document you posted earlier (tx - cool document), and simple math, it is virtually certain that is what they did.