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Biotech / Medical : XOMA. Bull or Bear?
XOMA 25.81+1.1%Dec 16 3:59 PM EST
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To: Robert K. who wrote (8327)1/17/1999 2:24:00 PM
From: aknahow  Read Replies (1) of 17367
 
Back to the future!

+george wohanka (2168 )
From: +Techperson

XOMA gave a strong presentation at the Alex Brown Conference on Monday, including a one-hour breakout
session. There was no news on the trauma study yet; that data should be on its way to six big pharma
companies by the end of this week, but it is preliminary and won't be released yet.
They have enrolled 65 of the 130 meningococcemia patients and have 6 deaths, so they are VERY suspicious
that kids taking the placebo are dying and kids taking the drug are not. They clearly are wrestling with what to
do, as in their minds it is approaching unethical to continue to give the placebo, yet they need to get enough data
for an FDA signoff. The forthcoming climical trial oversight meeting will peek at the data and make a
recommendation; sounded like June.



The FDA asked them to try BPI against sepsis! Casey asked the FDA if they would change their standard to
measure sepsis-caused deaths instead of all deaths. They said no, and he told them he could not spend the
shareholders' money on a project sure to fail because the FDA has wrongheaded standards.
IMHO, the value of their research pipeline is about to double or triple when the trauma data is released and the
meningococcemia study is converted to open label because the drug is so effective.
IMHO, the value of their research pipeline is about to double or triple when the trauma data is released and the
meningococcemia study is converted to open label because the drug is so effective.

Note I believe Techperson was Murphy.

Pay particular attention to this:

The FDA asked them to try BPI against sepsis! Casey asked the FDA if they would change their standard to
measure sepsis-caused deaths instead of all deaths. They said no, and he told them he could not spend the
shareholders' money on a project sure to fail because the FDA has wrongheaded standards.

XXXXXXXX My question is was something else said? One can understand the FDA not wanting to split hairs in trying to determine who died from actual sepsis and who died from from say the original cause of the sepsis, a gunshhot etc. So I wonder what the real disagreement was about.





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