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

To: aknahow who wrote (14688)	9/17/2000 6:23:34 AM
From: Robert K.	Read Replies (1) \| Respond to of 17367

George, I really hate to admit this but I actually totally agree with you about the 6 hr delay vs underpowered. >they are one in the same. Its underpowered BECAUSE there was a 6 hour delay BECAUSE of transportation issues THAT CAUSED most of the children that WOULD HAVE died to DIE before ever getting the CHANCE to get bpi. IMO this meant that many of those 12 to 15 glascows NEVER got into the study CAUSE they were dead. THUS it was underpowered because the FDA didnt see all of the kids DIE that it was hoping for(scratch that). It didnt see all the kids die that it wanted(scratch that) It didnt see more kids get placebo and die vs just die(scratch that) It wants to do another study so it can see more kids die the way it wants so as to prove bpi works(scratch that) The fda really wants to protect kids who are dying from a safe and beneficial drug(scratch that). The FDA wants to protect kids from from dying from a drug that may only save a few lives(scratch that). Its underpowered and does not meet the fda standard, so the drug is not proven effective. That sounds right, that last statement must be right. All Just my opinion. I have no idea what the fda is really thinking.

To: aknahow who wrote (14688)	9/17/2000 12:31:53 PM
From: Cacaito	Read Replies (1) \| Respond to of 17367

Gw, 6 hour was also the delay for placebo. Same conditions operating for drug/placebo is the aim of the RTC (ramdomized trial with placebo control and blindness, the universally recognized higher standard of proof in epidemiology investigational clinical medicine). It is mock cry from whoever talk about that, real trial conditions determined the results, not anyone ideal conditions. The moral reasons for informed consent, IRBs committes, ethical protocols is based on long history of abuse, nazi, imperialjapanese experiments, the Tuskeggee men syphilis, thalidomide, breast implants, torture with clinicians directing, canada/australia misplacement of aborigines, the church, mental illness treatment, orphans,.... Bpi is very safe, but there is no way around the above, too bad. Surprinsingly, the best science has come while respecting ethical protocols, unrestrained experimentations in humans (and animals, enviroment,plants) is the cause of huge damage. Approval of a drug just for safety and let the market decide is just plain unworkable, you in the comfort of your orange juice bedroom can not comprehend the difficulties in such scenario. Look at the clinicians who decide to turn into women the boys born with some anomaly or accidents in the genitalia (like cutting the penis during circumcision)30 to 40 years after it was a disaster, a tragedy, when almost everyone the big mistake, 40 YEARS LATER! In many poor countries informed consent is taken over by institutions and some oral formality with the subjects, but it is clearly not financially appetizing for a xoma like enterprise.