To: Slugger who wrote (14718 ) 9/18/2000 12:28:19 PM From: Cacaito Respond to of 17367 Standard treatment IS antibiotics, no way around, REAL world. Plus, nobody will dare not to use antibiotics, will go to JAIL. Slugger, In all treatments there is: 1. an extreme group that does not benefit because NOTHING works (many of the 53 deaths belong to it) 2.an extreme group (big one) that do not benefit cause they will get better with standard treatment 3. the group in between THE SMALLER that will indeed benefit. The trial must discover efficacy DESPITE this three groups, once efficacy is establish the three groups will get the drug in the real market place. The only argument somewhat valid is time, earlier (theoretically)better, but there are real world constrains and only way around is a divergence from certain "standard" ethical grounds. xoma could go around doing a bigger and expesive trial to prove the trend toward less amputations. BIGGER PROBLEM is that xoma will not embark in that route CAUSE the value of the drug will decrease, is not the same to save lifes vs save fingers. Argue all you like, but reality is real trial conditions, not ideal ones. And it does indeed works both ways, the 53 death will be assigned to BOTH groups in a ramdomized trial, AND many more than what you think (or WISH) will die despite early treatment with bpi. GRANTED, earlier increases the chances of bpi, but it does not assured it. Maybe later over the years when pafase/zovant comes out to the market bpi could have an easier way to prove itself, but market value will be less. And xoma could do something easier faster, get baxter to work in common sepsis schock, something they could have chosen DURING the time of the meningo pIII trial, but xoma chose at the time to do TRAUMA, a theoretically (and at the time practical idiocy, cause they have clear numbers from pII) and they went ahead with it cause it was somehow easier(logistics were in place, same centers/scientist, know expenses as pII, as opposed to a "new" subject SEPSIS> There are many mistakes alone the way of development of Neuprex. Caveat: I was always a supporter of the meningo trial decision. I was an early advocate for trauma pII based on xoma's pr, but once I thought the pII data on J of Trauma(one year after) I understood the early fears of MANY (Gw was strong against it, he was only doubts when it failed. No flame purpose Gw). I did not like it, predicted failure was easy. xoma and only xoma is responsible about neuprex fate to this point. Only good execution has been the business side of it, MILLION$ from the Street.