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


To: Cacaito who wrote (8469)1/25/1999 10:26:00 AM
From: aknahow  Read Replies (1) | Respond to of 17367
 
Just a reminder of the importance of what you have told us. In 1996
Centoxin was turned down for approval in the U.K. Here is cut and paste on this drug. Source is Giroir, in Lancet correspondence.

"In another trial in 269 patients with meningococcal sepsis HA-1A reduced
mortality by 30% (p<0·08).5"

Think this demonstrates why XOMA would continue the trial to assure it has a better chance to gain approval, since p<0.08 with a 305 reduction in mortality was not considered sufficient in the past.



To: Cacaito who wrote (8469)1/25/1999 6:17:00 PM
From: Robert S.  Respond to of 17367
 
I guess what it boils down to is that you are viewing circumstances through an optimistic eye, wheresas I am looking at prospects through a skeptical orb.

Interesting approach to designing protein drugs:

forbes.com



To: Cacaito who wrote (8469)2/3/1999 2:18:00 AM
From: aknahow  Read Replies (1) | Respond to of 17367
 
From XOMA:

They are at 350 accrued. And ..

It's a two
> armed trial: placebo and treatment (all one dosing regimen) but the
> severity scores are stratified: 8-12 and 12-15 in order to keep track of
> probable differences in rates between those two populations. Assumption is
> that mortality gets higher the higher the GMSPS score.)
>



To: Cacaito who wrote (8469)2/3/1999 12:46:00 PM
From: aknahow  Read Replies (2) | Respond to of 17367
 
Cacaito, I know you no longer have access to the needed software and also that we will have actual data reasonably soon but I would still like to have your opinion.

With 350 total and 175 in each arm, total deaths assumed at 40 with mortality at 8% in the treated group and 15% what confidence level would we have?