XOMA. Bull or Bear? Message Board

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Biotech / Medical : XOMA. Bull or Bear?

XOMA 26.52

-22.9%

3:59 PM EST

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To: Slugger who wrote (8320)	1/16/1999 11:43:00 PM
From: aknahow	Read Replies (1) of 17367

No, that is not the case. If one goes back to the fact that this is a rare disease it would have taken years and years to get a sufficient number of accruals to become a statistically significant trial. During those years many kids would die. It was a sound decision on the part of all the FDA the DSMB and XOMA to arrive at a compromise method which would provide convincing data for the medical profession, scientist and officials at the FDA. It evidently became clear that the quickest way to get there was to allow the trial to be halted when ??X?? number of deaths occurred. But things changed as the U.K. was added. Yes this meant now it might have been possible to do a trial based on accrruals. Yes the U.K. resulted in more deaths in total quicker than expected. But then quicker diagnosis in the U.K. might have lowered deaths and then if BPI is effective even fewer might have occurred. So the U.K. is what is making it posssible to halt the trial sooner. And with 20/20 vision knowing how many the subjects the U>K. would add a different trial design might have been possible. But does one risk stopping the trial before the mandatory number of deaths have occurred, when the data is blinded to management? If you guess wrong, and stopping is not acceptable, then your drug never gets to the kids. In this situation of a rare disease I think everything was done by all to find the quickest way to end this trial. Disclaimer. All the above is based upon only one fact, "total deaths" Everything else is pure conjecture, none if may be true some of it may be false. I have no knowledge of how the trial was designed nor any knowledge of how the FDA made its' decisions on this trial. I still believe the FDA should only be in the business of determining safety, but at the time the trial was designed I think what I speculate was done was a great decision, and one that was designed to save lives.

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