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


To: manfredhasler who wrote (14698)9/17/2000 10:20:24 AM
From: Robert K.  Read Replies (1) | Respond to of 17367
 
So manfred, can you defend the FDA's decision to over-ride
standards for the HIV drug? How is that any different from BPI? Subpart E (which bpi has) gives the FDA broad discretionary authority. Apparently, the FDA has thusfar chosen to withhold decision on bpi, but yet they can really move things along for that HIV drug.



To: manfredhasler who wrote (14698)9/17/2000 3:25:34 PM
From: aknahow  Respond to of 17367
 
This could be endless, so please understand I am not trying to respond to everything you say. In this country we say, sometimes a banana is only a banana.

The two countries are very different. While I am a parent that would delay, most U.S. parents probably would not. Kids have mothers. They get their children to doctors and here for this type of disease the delay is less. One poster, a nurse, saying she participated in the study said it normally took 30 to enroll a subject. Yes, sample of one etc. I do know from experience that almost anywhere in this country they get you to a hospital very quickly and the E.R. rooms treat the most serious indications first. I have never been to the U.K. I am not an anglo. I have however seen how government controlled health care does not work. The delay was 6 hours on average and my understanding, based on an e-mail exchange, is that this was not the time spent getting kids to the center but in enrolling them in the trial. It remains to be seen if that is correct. The details on this six hour delay are as you said needed. I will bet that most of these delays, occured in the U.K. on a relative basis, since we already know that most of the subjects were from the U.K.



To: manfredhasler who wrote (14698)9/18/2000 8:48:43 AM
From: aknahow  Read Replies (1) | Respond to of 17367
 
Manfred, do you actually know what the tumbler test is? If so how could you say this: "
BTW: I am very sceptical about a possible benefit of (prospective) parental education in
meningococcemia. On the other side, I am much less sceptical in stressing the importance of proper
execution to the medical profession. "

The beauty of the tumbler or glass test is its' simplicity and understandibility. A parent simply presses a clear drinking glass against a rash. If it does not disappear they should get the child in to a doctor for examination at once. While not infalable the concept is understood and can be shown to millions repeatedly on t.v. and even in print.

Perhaps U.S. doctors were too proud, must be the Swiss genes at work, to get behind doing this in the U.S.