While we wait...
...to see if it's caviar or cat food for Xoma investors, here's a small mystery, which may have been discussed before, that now takes on added magnitude in light of recent developments.
From the Xoma FAQ (mystery in caps):
What is an interim analysis? (6/98)
Interim analyses monitor the conduct of the study and look for unexpected safety or efficacy issues. During a trial, the DSMB are the only people that are unblinded to the data (i.e. know which patients received drug and which placebo). All they report back to the company about results is that the study can continue, or that the study should be stopped early, because of an unexpected safety or futility problem, or alternatively, unexpectedly higher efficacy than planned for that study. Studies are not designed to stop at an interim analysis, BUT MANY DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDIES HAVE INTERIM ANALYSES IN CASE OF THE UNEXPECTED.
So, guys and gals and doctors and patients -- and George -- what do you suppose was the "unexpected" warranting so many (3! 4?) interim analyses by the DSMB in '98? |
