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

To: xomadog2 who wrote (9974)	5/14/1999 7:13:00 PM
From: schadenfreude	Read Replies (1) \| Respond to of 17367

>That is why among other reasons,BPI is being used in Menningococcemia > instead of SEPSIS. The FDA still wants to do a SEPSIS trial with BPI >using mortality as the primary end point. Assuming all goes well with meningococcemia, what additional trials will be needed for sepsis and how long will they take? If another trial is required, what was the point of wasting 3 1/2 years on a niche indication that doesn't come close to justifying the the massive investment in time and resources?

To: xomadog2 who wrote (9974)	5/14/1999 7:51:00 PM
From: aknahow	Respond to of 17367

Problems with a trial and meeting ones objectives do not mean the FDA was opposed Pfizer. Note that XOMA has explained the difficulty of trying to demonstrate the potential benefit of a drug when multiple problems exist in a patient. The sepsis might be cured but the patient dies of something else. I did not say there were no problems, I said only that the FDA was was not the problem. All sepsis trials have failed to date. Was the FDA the problem in all these trials by all the companies involved? Do you want to go on record as saying the FDA did not like a drug because it did not kill bacteria? Yes I think BPI has a much better chance of being effective because it kills bacteria and binds endotoxin. Lets hope the FDA does not determine what kind of trial XOMA runs.