To Ellen and the Old Xoma Threadheads (George, RobertK, Tharos, etc.):
Try as I might, I cannot understand the DSMB news and Xoma's FAQ response about yet another DSMB meeting. RobertS raises a very disturbing possibility that makes logical sense. I'm not sure anyone has come up with an alternative, but I'd love to hear it. Slugger sort of tried, I guess, by asking rhetorical questions but I don't find his points convincing.
Slugger: >>if the DSMB is sure that Neuprex does not work then why are they wasting their time with all of these extra reviews?<<
Isn't the answer that the trial was designed for 2 years and the DSMB sees no safety reason to discontinue it, so why not let it go to completion?
Slugger: >>It doesn't make sense that they would ask for all these extra reviews just to look at data that isn't showing efficacy.<<
Isn't a further review exactly what Xoma would want as a last resort if the DSMB is not seeing efficacy? Sort of like, "Coach, I know I'm ten behind but stick me in the line up for one last game, anyway. Maybe I'll get lucky and hit enough homers to pass McGwire."
Another thing I don't understand is the FAQ reference to the possibility of changing the design of the trial. How on earth can this be done at the eleventh hour? To the extent one end point of the P-3 is mortality, dead is dead. To the extent there are other end points involving varied complications or morbidity, surely the study design encompassed at least the most common ones; wouldn't any efficacy analysis look for each in turn as well as in combination? Various permutations can't be all that tough in an age that has solved Fermat's Last Theorem. Data is data, right? So how is it possible for Xoma to tweak a P-3 design as it is ending to satisfy the DSMB or the FDA?
I don't get any of this. |
