To: Robert K. who wrote (14585 ) 9/16/2000 1:44:26 PM From: manfredhasler Respond to of 17367 Robert, I have just a problem with the study. And this can hardly be wrong. Actually I have several problems with the study: with the presentation of the results, with the investigators, and with XOMA's management. The problem with the study results are already reported. Some of them might be resolved if I can see the details in the full publication. I will check that and if the details I am looking for are not addressed I consider to write a letter to The Lancet (to be published in the Correspondence section). The problem with the investigators I did not yet mention. But since you seem to have high respect for Dr. Brett P. Giroir, of Children's Medical Center in Dallas, Texas, who belongs to the principal investigators, I want to add my objections. I think the investigators are the first ones to be blamed if a study does miss. They are responsible for the scientific part and the execution. As scientists they are solely responsible. And they have a lot of financial help form the funding company. I strongly believe that the study failed because it was wrongly executed (note: not because I question the efficacy of the BPI). Obviously Giroir himself is convinced of the benefit of BPI from his observations with his own patients. But Giroir's challenge was, along with the other principal investigators, to take care of an optimized study protocol, his chance was to take care that the study was properly done. If it is true that the delay of 6 hours was cause of the death of so many more children (note again: exactly this has not been shown with the study) this notion deserves not only a footnote in a scientific report. The principal investigators should be blamed and made responsible for the failure. I do not know the reason for Giroir's recent activity. It does however not compensate for any failure now to go out to the press and try to convince them to make lame PR articles for any reason. And for the management: if with this pivotal study it was not able to show a benefit of BPI - and the management still claims that the drug works - the management continues to mess up. I noticed a certain degree of uncertainty in there new FAQ. At that time I gave them the benefit of doubt. I did not expect them to be just incompetent. For a investor however they are the only one I can react to swiftly. Regards, Manfred