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Biotech / Medical : XOMA. Bull or Bear?
XOMA 32.31+1.4%Nov 26 3:59 PM EST
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To: Edward Paule who wrote (6398)6/2/1998 10:28:00 AM
From: aknahow  Read Replies (1) of 17367
 
Ed, I don't agree with some of your post. It is my understanding that the DSMB is really concerned with safety. Yes, I understand it can also recommend stopping when there is overwhelming efficiency. With just 100 receiving Neuprex it becomes statistically difficult to prove overwhelming efficiency. Remember that even if the overweight patient, in the open trials were excluded, and there were 25 out of 25 cured their would not be statistical reliability or a high enough level of confidence, due to the small sample.

Therefore the DSMB will not stop a trial because it wants to help get a companies drug to market before a new seasonal outbreak, nor because it somehow decides, the FDA now will have enough data. From the start we have been told that 200 was the minimum number of patients that the FDA would accept. XOMA for financial reasons wanted to limit the trial to two years. The FDA agreed and helped out with granting subpart E status. Once it became clear the 200 would be accrued before the end of two years XOMA knowing that the FDA would have preferred more than 200 and that the number in the trial is important to demonstrating statistical significance opted to keep the trial going beyond the 200 number.

Bottom line, is that no matter how much I would love to see the trial stopped and early approval achieved I don't believe this is a reasonable expectation and I am convinced the best management decision is to continue as planned for the two years and obtain the maximum number of patients.
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