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

To: Bluegreen who wrote (11361)	8/18/1999 2:53:00 AM
From: aknahow	Read Replies (1) \| Respond to of 17367

Aug FAQ from XOMA site. Worth reading, appearing now on xoma but not on XOMA site. NEUPREX®: Meningococcemia update 8/99 When will you release results? (8/99) We will release further information consistent with our primary goal of maximizing the likelihood of product approval. We expect to provide additional information through appropriate scientific presentations and peer-reviewed publications accompanied by news releases. Has the FDA seen your preliminary data analysis? What did they think? (8/99) Yes. They agreed to review the complete data analysis with us. When is the FDA meeting to take place? (8/99) We need to complete the analysis and the FDA needs time to review that analysis before we schedule the meeting. When will you know if you are going to file your application with the FDA? What are your plans for a European Union filing? (8/99) We hope to determine this after our meeting with the FDA, but we can't guaranty that further meetings or discussions won't be necessary. Our current plan is to file in Europe as soon as practical after a US filing. . How many patients were finally enrolled? (8/99) 395 were enrolled and 393 treated. Were any patients excluded from the trial? Why? (8/99) A large number of patients were screened but not enrolled because they did not meet the enrollment criteria including disease severity. Will those patients be included in your analysis? (8/99) No, they are not part of the trial sample. However, that information may be useful in understanding the actual mortality rates in this patient population. What about the safety of the drug? Are there side effects? (8/99) XOMA has now conducted clinical studies in more than 2000 patients; more than half of them have actually received NEUPREX®. No safety issues have been identified by XOMA or any DSMB. Go to xoma.com for previous dates of FAQ questions. I do not know if I just had not seen these are if they are "new". Am posting them rather than just providing the URL since with so many post people may have little interest in checking them out.