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


To: William L. Molair II who wrote (8309)1/16/1999 9:29:00 AM
From: Arthur Radley  Respond to of 17367
 
Bill,
I will let George confirm what he was saying, but my interpretation was that the group "receiving" the drug had a lower death rate and the last time I checked....breathing was good for an individual.(:>)



To: William L. Molair II who wrote (8309)1/16/1999 9:48:00 AM
From: Tharos  Read Replies (1) | Respond to of 17367
 
I think what he has been saying is actually a summation of many bits of info posted by many individuals on this thread.

In late 1996, when the PIII trial began, the historical mortality rate when treated by traditional methods was 20%. In the PI/II trial the Neuprex treated death rate was something like 4%.

Since then we have noticed that people treated with Neuprex end up well and whole. We have also argued that the one death during the PI/II trial was probably due more to the kid being obese than to any other factor. We have also noticed traditional treatment for severe pediatric meningococcemia (meningococcal septicæmia) has improved and the death rates have fallen below 20%.

If the trial assumed 1996 death rates as a constant, then treatment improvements in either group would affect the test. In this case it is the length or duration of the test that is affected. If they originally said they needed 24 deaths, it would take 200 patients -- 100 placebo and 100 Neuprex. If you assume the Neuprex treatment group has 2% deaths (number pulled off the top of my head) and the traditional treatment group now has 10% death rate, then a trial based upon total deaths would take twice as many patients to accrue 24 deaths.



To: William L. Molair II who wrote (8309)1/16/1999 11:19:00 AM
From: aknahow  Respond to of 17367
 
After swearing not to post about this again, here I go. He said in effect the trial will end when total deaths, (the sum of deaths from the placebo group and the treated group), reach a specified number.

I am not saying that deaths are too low in the treated group. We and everyone wants to see few deaths for everyone but especially few deaths in the Neuprex group. But the fewer or lower the death rate is in the treated group the longer it would take to reach any specified number. Don't forget if the rate were high in the treated group the number would be reached quickly but the drug probably would not be any good.