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Biotech / Medical : XOMA. Bull or Bear?
XOMA 31.90+0.3%3:09 PM EST
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To: Cacaito who wrote (14727)9/19/2000 4:23:35 AM
From: manfredhasler  Read Replies (2) of 17367
 
Cacaito, Re:Many drugs and procedures are approve and highly praise with this type of difference in outcome, like aspirin, heparin, streptokinase, tpa, betablockers,ACE inhibitors, stents in heart attack/angina. The huge number of subjects in the studies, some as high as 10,000 provides the "Power" and later the "p" to be accepted.

Let us be more specific. My educated guess is that with about 400 patients (200 placebo and 200 BPI) an expected beneficial effect with BPI of 50% reduction in mortality(from 30% to 15%) had been proven. This with at least a 90% power and a 95% confidence level. I am confident that we can find the effective assumptions on which the study was based and the estimate computed by the biostatisticians in the original BPI study design. Maybe you have access to that.

The same would apply for other study criteria. No way 10'000 patients. My suspicion is that the investigators did not care about the proper patient inclusion and just continued to enroll as many patients as suggested by the study protocol. To the costs of the company.

My point again: you think nobody is to be blamed if the study did not give the expected results due to a failure in the execution? No answer needed if already given.

Regards,
Manfred
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