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

To: manfredhasler who wrote (14711)	9/17/2000 3:43:37 PM
From: Robert K.	Respond to of 17367

I find no objection or insult to your insistance on excellence. Unfornately in this case something was wrong and the kids are the ones to suffer. In either case, bpi does appear to show benefit. Is there anyone out there that is disputing this fact? That said, in the absence of any other effective treatment, it is the best hope the kids have at this juncture. To deny them something that appears safe and beneficial in a life or death situation like this is wrong IMO. I continue to see no valid reason wny this drug should be witheld pending a larger open access evaluation to explore its true potential, not its impaired potential. I am with you Manfred, no excuse for screwups, but screwups are human nature. Lets not let more die when there is no safety issue here. Either the drug works or it doesnt. Rules are rules, and kids are kids.Give the kids a fighting chance at life.

To: manfredhasler who wrote (14711)	9/18/2000 12:42:29 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

Manfred, I am sure xoma will love to have the drug given the way you suggest, It was not allowed to do it, it is very real, informed consent was mean and a must to be obtained in the trial BEFORE the drug admninistration. One could argue long and that is the fact. I met Dr Giroir, he was a moderator of a Pediatric critical care sepsis seminar in New Orleans meeting of the Amer Acad of Pediatrics/Society for Pediatric Research, and He is very good on the clinical science part, and I am sure He must be red hot with the REAL world constrains. Sometimes I feel like Bluegreen and his FDA concerns(but I try not to invest with my emotions). The amputation side of the trial from 7.5% to 3.2% is a very strong trend, just increase in N will probably be enough. Many drugs and procedures are approve and highly praise with this type of difference in outcome, like aspirin, heparin, streptokinase, tpa, betablockers,ACE inhibitors, stents in heart attack/angina. The huge number of subjects in the studies, some as high as 10,000 provides the "Power" and later the "p" to be accepted. I do not blame the scientists and clinicians at all. My Point.