To: Robert K. who wrote (14767 ) 9/20/2000 2:03:31 PM From: Cacaito Respond to of 17367 From The Lancet: "Among patients who survived to receive the complete infusion of study drug, mortality was 6·2% in the placebo group and 2·2% in the rBPI21 group (p=0·07). Although the reduction in mortality for patients receiving rBPI21 was not significant, substantial effects on morbidity were observed." This is more consistent with the meningo bpi pII findings aka 4% mortality even better here with a 2.2%, if the study is increase to 800 to 1000 patients then a difference could be proven, but here there is a clear bias toward the "best" patients, "good enough to survive, bad enough that they could die", not the imminent death ones, not the sure improvement ones, the information is just a trend, again. The issue is past the point of no return, xoma will not embark in something similar, there are chances that the same could happen in other sepsis models, BUT the number of patients could be recruited faster in a year or so, and the total could go to the 2,000 to 3,000 ; A La LILLY. Rk, xoma design was fine, I would have been strict in keeping the two GMSPS arms separated, and even completing one as the other keep going, but number of subjects was critical in both arms, lower to proof less amputations, and higher to prove less mortality. But MONEY expenses will be doubled or triple is a vicious circle. The model is too expensive, I calculate that each patient must be like $20,000 each or $8,000,000 just for study expenses, if the institutions required the payment for the usual care (and in the US is the norm that insurance do not pay and then the Pharma house must, except some Medicare/Medicaid coverage) one could add some $40,000,000 to the expenses. Some institutions take the Medicaid money and still demand the Pharma to pay the same expenses. Plus, the salary of the scientists/pharmacists/xeo/pr....