All of this is most interesting. (Applause) But it does not change the fact that the required mortality is about to be reached, at least if the CEO's statement of the past week is to be believed. What does "near" mean? Let's assume mid-April, or roughly 12.5 months after the earliest hoped-for end to the P-3.
So here's a mind-numbing math question of the sort you folk might like: Xoma designed the trial to end with a total mortality number of N. Using historic mortality rates in untreated patients and Neuprex-treated patient populations from the P-2, Xoma likely projected the trial would take 36 months [is that about right?]. In fact, however, the time it has taken to reach a mortality of N has been 36+ 12.5 months. So, based upon the newly published tables assigning specific lower overall mortality rates, now it should be possible to calculate what N is, or the total number of deaths needed to end the trial.
Using that number, of course, one then can divide it between the two arms, say along the lines experienced during the P-2, and joila! An educated guess as to what results Neuprex SHOULD be expected to achieve if it is to be effective to the desired degree of statistical certainty.
I'd be happy to figure this out for you all, of course, but I'm tired now and I have to lie down. Good luck. |
