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Biotech / Medical : XOMA. Bull or Bear?
XOMA 26.33-8.6%Jan 16 3:59 PM EST
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To: aknahow who wrote (9275)3/19/1999 9:25:00 PM
From: aknahow  Read Replies (1) of 17367
 
While no further discussion is required I am amazed that I did not get it till now. In part it was my thinking that the FDA set the numbers when in reality they probably set the requirement that their be a pre established mortality level. Xoma was free to determine expected mortality in both arms and then seek approval of this component of the trial design from the FDA.

You are right on the blind bit also. At first that helped me understand it but then I saw it even without going into it in my post.

If for example the mortality target came only from the placebo arm and it was for example 200 then should the DSMB report to a company that mortality was 300 but the trials were not ending then the trial would be unblinded to the extent that the company would know that over 100 of the deaths came from the treatment arm.

It is of course true and Martin did mention that reduction in mortality from improvement in the standard of care would also be a factor in determination of the time required to reach the target. I understood this from the start, but am mentioning now to be sure others do not think there was any implication the trial was being extended only because of fewer deaths than expected in the treatment arm.
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