There has never been any doubt in my mind that a company, any company, can stop a clinical trial when it wants to or needs to. Even in the face of a mandated mortality number a trial could be stopped early on because the company no longer has the financial ability to continue the trial. In the specific case of XOMA, if they have not reached the required mortality number they can decided to end the trial but then the FDA can and will make its' own decision as regards to the effectiveness of the drug. This, however, would be the case even if the mortality had been reached. We have heard the terms close, very close and now really close, so I continue to believe they are so near the target, that the FDA will not just say "No, you did not reach it, Neuprex can not be approved." Think the F.D.A. will look at the data and if the failure to reach the mortality level is due to the drug working they will look closely at the results, and not automatically dismiss it.
I agree that XOMA has said that only after the 90 day waiting period would detailed information be released. But letting us know the mortality requirement, total deaths and if possible after ten days the mortality to that date by treatment and placebo arms would not seem to be something impossible to do, nor wrong to do.
BTW last week supposedly accruals were @ 390. Not clear that these were actual numbers, rather it seemed more like they were "recaled" numbers. Like, if I recall correctly...." |
