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Biotech / Medical : XOMA. Bull or Bear?

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To: Bluegreen who wrote (10186)	5/26/1999 7:53:00 PM
From: Cacaito	Read Replies (2) of 17367

The 62 unfortunate death patients some were ineligible on arrival, but my guess is that most deteriorated before "Informed Consent" could be obtained and deterioration persisted to the point of inability to be recruited. The "informed consent" problem is a plague for trials aim to very acutely ill people with grave conditions, in children cases family members are the ones to give consent and people is very suspicious of trials these days. As cumbersome as it is, better science is the result, albeit slower. My number was 47 base on very conservative calculations, 34 seems to be very low and my guess is that either patients were enrolled early with high chances of survival or the drug works wonders. I am waiting for unblinding before I invest a single cent more. 62 is indeed an awful lot of deaths, mortality continues to be high. I posted from the hem/trauma trial and the exclusion criteria was so extensive I did not post the list. This is part of the problem here, and it is very important to recruit with extreme care. The ethical reason is that drug is not proven so standard of care is the appropriate response. Compasionate use of the drug could be a possibility, but "informed consent" still required, lots of documentation and everybody involved is liable (especially the company)for unwanted results. Very complex indeed. Final distribution of patients is not necessarily equal on each of the two Glasgow scores groups, and it is not equal either on the sudivision for treatment and placebo. A significant higher number of patients in the treatment group could happen by chance and very low number of deaths if the drug works could be the result. The ramdom distribution aims to but does not insure an equal distribution of patients on each group.

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