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Biotech / Medical : XOMA. Bull or Bear?
XOMA 28.68-2.3%Jan 15 3:59 PM EST
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To: aknahow who wrote (10308)6/3/1999 11:24:00 AM
From: Cacaito  Read Replies (2) of 17367
 
George, What is this 62 non trial cases added to the trial cases?

Murphy added these 62 non trial cases to the total ? this is wrong.

If one add 62 non trial cases to the placebo group? this is also wrong.

The 62 non trial cases are not acceptable for any of the calculations of the drug efficacy, "intent to treat" is the norm.

There were 4 deaths on bpi? out of the 62 group? out of the trial group? is this from annual meeting? Compassionate care? error of enrollment? imminent death was one of the exclusion criteria.

From Xoma's web site the majority of patients (80% to 85% ?)enrolled were of the Low G score.

Low G score, I expect a high of 15% mortality (conservative 8%).

High G score, I expect a 60% to 80% mortality (conservative 40%).

There is a possibility of zero bpi deaths in the Low G scores, considering the very low number of deaths in the trial as a whole.

The 62 cases of death that were not enrolled are a potential huge problem. Xoma must have extremely good documentation as to why they were not enrolled.

Especially the non enrolled cases estimated as imminent death.

The use of compassionate care of the drug, if any, must be fully explained as to why not enrolled to the trial.

The easier explanation and easier for FDA to digest is lack of informed-consent.
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