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Biotech / Medical : XOMA. Bull or Bear?
XOMA 26.67-10.7%Jan 12 3:59 PM EST

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To: Cacaito who wrote (10398)6/10/1999 4:19:00 PM
From: Edward Paule   of 17367
 
>>>>>>>> I would have like more a Phase III trial on abdominal infections (great phase II results)for a clearcut gram-negative indication. I do think they will go ahead with a phase III in due time. <<<<<<<<<<

>>>>>>>> for a clearcut gram-negative indication <<<<<<<<

>>>>>>>> for a clearcut gram-negative indication <<<<<<<<

I've bemoaned this for years. This is my NUMBER ONE problem with Xoma's trial designs.

All the research indicates rBPI21 will only work on gram-negative bugs. So why waste time and money persuing non-gram-negative indications?

Less than half of ARDS patients have a gram-negative infection. Less than half of Cystic Fibrosis patients have a gram-negative infection. Partial heptecomy ???. Is it so hard to find other indications like meningo and pnuemonia that are mostly/all gram-negative?

I can only assume it's an FDA labelling issue. If successful in a broad indication, the drug can be given to everybody (more sales). If the drug was only tested in known gram-negative cases, would the labelling indicate that a gram-negative infection be tested for and confirmed in the patient prior to administering the drug?

Just my opinions,
Ed.
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