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Biotech / Medical : XOMA. Bull or Bear?

XOMA 29.81

-4.2%

Dec 5 9:30 AM EST

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To: Robert S. who wrote (8366)	1/19/1999 10:34:00 AM
From: opalapril	Read Replies (1) of 17367

Back to the P-3 issue. Supposing it is true that a specific number of overall deaths in the experimental and control group tolls the end of the study -- a conclusion that I think remains speculative until confirmed by Xoma or the FDA -- it would appear Xoma seriously misled the public. Check out these answers in the FAQ from the company's web page: Q. How long will it take to complete the trial? How many patients will be enrolled? (6/98) A. We plan to complete the trial at the end of 1998 (two years from start). The final number of patients enrolled will be the number we have accrued by then. Q. Why didn't XOMA stop the meningococcemia trial at 200 patients? (6/98) A. The original Phase III design agreed to by the FDA called for a two year trial. Our intention was (and is) to accrue as many patients as we can in two years. * * * Q. Do you have an estimated date that the Neuprex(tm) data will go to the FDA for final review? (6/98) A. The meningococcemia Phase III trial is scheduled to complete enrollment at the end of 1998. The earliest we will know results is after the 90-day follow-up period. Assuming the data are positive, we would complete the BLA (Biologics License Application) filing to FDA most likely by midyear. Now, "scheduled to complete enrollment" and similar thoughts here were very clearly expressed: the trial would be "complete" at the "end of 1998." This seems to me very different from an open-ended termination dependent on specific endpoints or treatment milestones. Someone suggested I call Ellen. What good would that do? If she prevaricated on the web, why wouldn't she prevaricate on the phone? And if the total deaths business is an invention of Murphy's (I'm still not clear on where all of this talk originated! Can someone please help me out here?) then why bother Ellen with fictions? No personal offense intended, Ellen. Either way, I understand it's your job and I'm sure you do it magnificently.

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