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


To: aknahow who wrote (8428)1/22/1999 4:19:00 PM
From: Cacaito  Read Replies (1) | Respond to of 17367
 
Find it!!!. Thank you again, Tharos. Thank you again, George.

Message 4967600

I have being trying to get the trial protocol and it was in the
sink bowl all the time. Please do no waste the thread legacy.

They are two arms of Bpi patients in the study (arms, please stop
the legs non-sense that is the market bull who has legs). And one of
placebo patients. That's the reason for the season.

One needs more than 100 patients for each arm, if one ones to be
conservative (parsimoniously agree) then one has to go for more than
300 subjects.

Also check the post # 638.



To: aknahow who wrote (8428)1/22/1999 4:39:00 PM
From: Biomaven  Read Replies (1) | Respond to of 17367
 
george,

A perfect example of the dangers of subset analysis. From a description of ABTI's previous study:

In the upper GI surgery stratum (non-colorectal, n=391), there was a prominent and statistically significant reduction in serious post-operative infections in both Betafectin dose groups versus placebo. The percentage of patients with serious infections decreased 39% in the two treated groups compared to placebo; 46 of 129 (36%) patients in the placebo group experienced serious infection, while 29 of 132 (22%) patients in the 0.5 mg/kg Betafectin group and 28 of 130 (22%) patients in the 1.0 mg/kg Betafectin group experienced serious infection (p=0.01). This key result provided the basis for the ongoing confirmatory trial in upper GI surgery patients.

Peter



To: aknahow who wrote (8428)1/22/1999 5:13:00 PM
From: Cacaito  Respond to of 17367
 
George, please noticed in the trial Bpi protocol criteria: below 8 Glasgow
score do not entry study.

Even the lowest score arm patients are significantly ill (shock inminent),
and the highest score are very ill (shock).

Xoma's chances:
1. no effectiveness in neither group.
2. effective in severely sick patients, not in moderately ill
3. effective in moderately ill, not in severely ill
4. effective in both groups

This is a clever design, and if one adds the appropriate number of
patients, chances are better for obtaining strog data.

The company that gave xoma $25 millions is not unhappy with more
subjects in the study.