XOMA. Bull or Bear? Message Board

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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: Cacaito who wrote (8341)	1/17/1999 8:17:00 PM
From: aknahow	Read Replies (1) of 17367

Cacaito, companies would still need to demonstrate effectiveness to the satisfaction of the marketplace. But once the FDA was able to concentrate on safety only one would think they could do a better job with fewer resources. I understand what you are saying about clinical trials. Yes, any company can stop a trial when it chooses but then it may or may not be able to even try for approval. The P III was originally set for 2 years. If the U.K. had not been added at the end of Dec. the trial would have only accrued 75 patients. If non treated had a 20% mortality about 8 would have died in this group. Say 4 for the treated group. If mortality was the key end point would a n of 75 with 8 deaths in the placebo group have been of a level of statistical confidence that would have permitted approval? Doubt it. Can see why someone might have said we understand why you want to end the trial in two years but there is no way we are going to evaluate the results unless there are at least X deaths to analyze statistically. With the addition of the U.K. things changed. At any rate as slgonzalez said call XOMA to get your questions answered.

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