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


To: Cacaito who wrote (14593)9/16/2000 4:12:28 PM
From: aknahow  Read Replies (1) | Respond to of 17367
 
Cacaito, remember that the FDA required certain methodology in the study. While we will never know just how the design was influenced by the FDA it would be interesting to know.

I have personally sen how utterly stupid and non productive government interference can be, and was in two projects I worked on.

I will wait for you to find the Glasgow numbers. I am shocked and sad that you have forgotten that all subjects were required to be at grad 8 or above. In the open label trial the patent cites a grade 14. We should not have to be going over this basic data and I would think we should use care to not mistate facts. We all make mistakes but to keep
saying those treated were not the sickest is not up to your usual standards of fairness.



To: Cacaito who wrote (14593)9/18/2000 12:05:37 AM
From: Slugger  Read Replies (2) | Respond to of 17367
 
You still do not get it, the placebo enrollment goes under the same conditions, same 6 hours, same IV access problems, same transport
problems, same INFORMED CONSENT problems, and that is the BEAUTY AND THE SCIENCE of all of it, that it is REAL blinded, that the
same conditions are operating, and there is not room for EXCUSES, except to market types that ridiculously call for the children (no
bias here, but couple of xoma shares)and do not comprehend honest statistical science and the best evidence epidemiology can provide
the true RAMDOMIZED PLACEBO CONTROL TRIAL.


Cacaito,

The problem is that most of the kids probably received antibiotic treatment before arriving at one of the trial centers. Even the 60 or so that died and were not entered into the trial received antibiotics. (So if you want to compute an overall death rate for the normal treatment add those sixty on top of the placebo group.)

Furthermore, the kids arriving at the trial centers could basically be divided into two groups. One group that was improving with antibiotics and the other that was not improving with treatment. The 60 I mentioned above were in the latter group; therefore, most of the kids entering into the trial were probably already improving (or at least stabilizing.)

Essentially, what I think the results are showing is a comparison of Neuprex (plus antibiotics) to placebo (plus antibiotics) in children, most of whom, were already improving with normal treatment.