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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: manfredhasler who wrote (14744)	9/19/2000 9:27:13 AM
From: aknahow	Read Replies (2) \| Respond to of 17367

When you began posting you spoke at great length about the scientific method and the danger of anarchy. Now even though you also said you would read the entire article, you continue to cast aspersions on what the investigators did based on your suspicious. Seems a bit fishy, at least to me. Are you aware of the fact that of the 34 children who died on 16 had received the full treatment? Eighteen died before receiving all of scheduled test drug/placebo? Four of the subjects receiving Neuprex died and 12 of those receiving the placebo died. but now of course the sample is way too small to be statistically conclusive, under standard FDA requirements. But Subpart E and orphan drug status was granted to XOMA. Cacaito says the surrogate endpoints not met. But the major endpoints were except not in a statistically significant way. So even though their were 1/3 the deaths in the treated group than in the placebo group and you post, <<<<<" 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.">>>>>> How does including 18 children that died before treatment support your suspicion that "investagotors did not care about proper patient inclusion"? Is your suspicion based on scientific thinking?

To: manfredhasler who wrote (14744)	9/19/2000 1:27:23 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

Manfred, I have post in the past very well calculated numbers similar to the ones you presented, about two years ago. My quick example of an "N" of to 10,000 has to deal with the actual lower mortality ranges, and the actual decrease from 9.2% to 7.5% (correct numbers?), one definitely need very high numbers to prove this. For amputations 7.5% to 3.2% the N will be lower but still probably like 800 to 2000. In many cardiac studies this are the kind of numbers that are use. Manfred there was a logistical problem, if they do not take all the lower mortality patients the study as the recruitment was going it was going to last 3 to 4 more years at best. There is no way around the actual low incidence of meningococci disease. It was the St Mary's Imperial College in London that was able to recruited most of the patients, if not it will have been worse. Except if one goes to an epidemic like three years ago in West Africa, then the problem is not time but resources and quality of the data, and the difference in care with the developed world. And were you said "beneficial effect HAD been proven" I am reading "WOULD HAVE or WOULD HAD" correct? Anyway, to assume that patients in more dire needs will benefit the most is higly speculative now that one see the difference in mortality in the actual "stronger" patients if they would have reduced mortality 70% in this actual group of subjects it will probably have been statistically significant, but there was some 22% difference at best (quick guess, got to get to those numbers). The protocol that we have in the thread in the past do not give the expected statistical expectations (We tried to guess it on the thread over the years), only a presentation of the protocol according to the modified Glasgow scores, exclusion criteria, arms division and so on.