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

To: Cacaito who wrote (8341)	1/17/1999 8:17:00 PM
From: aknahow	Read Replies (1) \| Respond to 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.

To: Cacaito who wrote (8341)	1/17/1999 10:25:00 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

The FDA has never done a great job in my opinion. That is why they finally had to change the last few years only after extreme pressure. Fast track, Pharmas kicking in money and other changes weren't the FDA's idea. Remember also that Congress just last year was considering limiting the role of the FDA in regard to efficacy. Hopefully this new Congress will pick back up the ball and run with it. I do foresee the day when more decision making is left up to the patient and clinician. We don't have the greatest healthcare in the world because of the FDA and third parties, we have it in spite of them.