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


To: xomadog2 who wrote (9008)3/8/1999 10:46:00 PM
From: Robert K.  Read Replies (1) | Respond to of 17367
 
Note the standard of care in the UK. Examine it wisely.>>>>>>>>>>>
>>>>>>>>>>
>http://www.archdischild.com/cgi/content/full/archdischild;80/3/290



To: xomadog2 who wrote (9008)3/9/1999 10:00:00 AM
From: Chris Boylan  Respond to of 17367
 
> I believe that you are missing the point.The primary endpoint
> of this trial is mortality,not morbidity.

Sorry I wrote that in haste. Obviously I meant mortality not morbidity in my original post.

If you will reread my original post I think you will
agree (or at least you should) that extending the trial twice
to increase the number of deaths included is best interpreted
as meaning that they have been unable to get usable results
despite a lower standard of statistical significance
set by the FDA.

Recall that originally they were going to enroll about 260 patients.



To: xomadog2 who wrote (9008)3/9/1999 1:14:00 PM
From: Thomas J Pittman  Read Replies (2) | Respond to of 17367
 
Isnt the point that people have to die since the
assumption is that when we unblind the results
we will see a large statistically significant
difference in the numbers of those who died on
the placebo and those who died on newprex?
If only three died and two died on the placebo
and one died on the drug, i guess the fda
could conclude 1) that the disease can currently
be adequately treated with existing technologies
since people are dying or 2) that there
wasnt enough difference in treatment/nontreatment
to justify a new drug.

But God help them if they unblind it and find that
there were no deaths on the drug and yet the trial
was allowed to continue with sick kids getting
sugar pills.

I am probably just slow on the uptake. Maybe all
of this is obvious to everyone else. Or maybe
its wrong. Maybe I am just so eager for these guys
to get something right so I can take my money
and go home.

J