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


To: Bluegreen who wrote (9375)3/24/1999 11:42:00 PM
From: aknahow  Respond to of 17367
 
Duh, the company also wants to get the drug approved. XOMA not the FDA nor the DSMB set the mortality targets. They may have done it in consultation with the DSMB and needed the agreement of the FDA but XOMA calculated what the levels need to be. They would not have put zero in the treatment arm since that would expose them to ending the trial sooner and if deaths in the placebo arm were less than estimated and even only slightly higher in the treatment arm they would be screwed. So IMO they must have chosen a level of mortality for the treatment group that when compared to the level in the placebo group would give them a statistically significant level of efficacy. That does not mean there must be actual deaths in the treatment group, but only that with 186 in that arm I doubt there were zero deaths.