XOMA. Bull or Bear? Message Board

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Biotech / Medical : XOMA. Bull or Bear?

XOMA 32.13

-0.5%

Nov 28 9:30 AM EST

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To: manfredhasler who wrote (14558)	9/15/2000 3:23:39 PM
From: Cacaito	Read Replies (3) of 17367

"I guess the study protocol was however based on this - false - assumption of 30% mortality rate." I have not had accesss to the full Lancet article (waiting for the print version in the library). But, the low mortality was a very well known feature and very well considered in the study design. There were two groups of subjects according to a modified Glasgow score for meningococcal sepsis. Low G scores has an expected mortality in the 5% to 8% and as per xoma they were recruting about 80% of the subjects in this group. It was clear long ago that the placebo group mortality in this low G was going to be very low and that most probably study will be underpowered unless couple of thousands patients were recruited, boviously a logistical nightmare and a financial imposibility for xoma. Higs G scores with the "classical" expected mortality of 30% that will again be short unless the drug has a strong effectiveness in the order of 30% to 50% decrease in mortality. They even has the so called "total mortality" number to stop the study, design for the high G score, but apparently apply to the whole study with the now known tactical miscalculation. Well, it was more lack of $ than anything else that stop the study, not the FDA, not the DSMB. The DSMB (Data Safety Monitoring Board)never suggested to stop the study for effectiveness, there was no safety problem, and the "trend" was enough not to stop it for futility (well, it is clear now). The summary is that xoma and only xoma is the responsible party of the design and execution of the study (quite good to tell the truth).

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