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

To: GregSL who wrote (8325)	1/17/1999 11:56:00 AM
From: Bluegreen	Read Replies (3) \| Respond to of 17367

Are you saying actions performed by the FDA or a DSMB are incapable of ludicrous behavior? I dare say that most decisions in regard to efficacy of a device or pharmaceutical by the FDA are indeed ludicrous at best. Do you actually think some pompous egghead involved in efficacy studies cares about dying children? I would venture to say most eggheads in that position are interested in their concocted numbers, nothing else. Safety by FDA is in severe trouble also. Recent examples being Redux and Duract. The FDA is only a puppet of a mickey mouse advisory board most of the time anyway. If FDA would concentrate more on safety and less on efficacy we would all be better for it. Only my opinions.

To: GregSL who wrote (8325)	1/17/1999 1:04:00 PM
From: aknahow	Read Replies (1) \| Respond to of 17367

Read your post and understand it. In fact I agree with it. But parsing my own words I do not believe I said the trial was being extended to reach a certain level of deaths but rather the trial was designed to stop when a certain level was reached. With that level it was felt statistical significance could be determined even if the total number of accruals was smaller than for most P III trials. Not reaching the level of deaths causes the trial to continue as planned from the start. This is not the same as extending a trial designed to stop when the number of subjects reached a certain level or a certain date was reached, for a new endpoint, total deaths.