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


To: Bluegreen who wrote (9537)4/5/1999 10:38:00 PM
From: Cacaito  Read Replies (1) | Respond to of 17367
 
Bluegreen, check: fdaweb.com many controversies and information about FDA work.

Check WLA story in prnewswire.

There is a possibility of a pro-trial bias and more patients getting in than the criteria will mandate, but it is usually a highly review
process and the room for this to happen is small.



To: Bluegreen who wrote (9537)4/6/1999 2:10:00 PM
From: aknahow  Respond to of 17367
 
Seems like some here and Mike Murphy too refuse to take XOMA at its' word that the mortality target alone would be used to determine effectiveness of Neuprex.

This being so, the fact that there were 125 or more correctly 130 and or 200 indicated as possible accrual rates has little to do with arriving at the original targets in both arms. I admit that once the targets were determined Xoma was able to provide what they believed to be the most likely accrual numbers for the trial.

This is important since the mortality level required is probably above 32. If it is 42 a number used by another poster after a conversation with Martin, it remains possible that the mortality levels have not significantly decreased, below 205, in the placebo group. I know the poster was careful to state that nothing being posted was a direct quote, nor should be taken as anything XOMA might have been said. In fact the 42 was provided as an illustration only. But even so it was used . My own estimates have been about 34 or 36, but if I knew how to determine a 95% confidence level only using mortality in either arm I would feel better. for now I think it is possible that 10 in the treatment group and 32 in the placebo group would provide the confidence level needed to approve the drug. but is this correct?