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

To: Robert K. who wrote (16960)	7/1/2004 10:07:42 AM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Bob, what have you come up with in regard to anti-cd40? Did DNA drop their anti-cd40 program and if they did why?

To: Robert K. who wrote (16960)	7/1/2004 11:46:20 AM
From: Bluegreen	Respond to of 17367

Bob, scroll down to the oncology part to see anti-cd40. What is the deal?>>>>>>http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=5587

To: Robert K. who wrote (16960)	7/1/2004 4:38:57 PM
From: Bluegreen	Respond to of 17367

Bob, why don't they resubmit? From that last article I posted.>>>>>>>>>>>>>>>>>Giroir, the first to propose using Neuprex to battle meningococcal sepsis, and his peers don't deny the second clinical trial failed to show a significant reduction in mortality or that the study had problems. Yet they all remain convinced Neuprex could be a powerful weapon to fight deaths related to meningococcal sepsis right now if they could just get it into patients during the first critical hours of the infection. Not only that, but the study showed that a large number of infected children treated with Neuprex went home with hands, feet, arms and legs they might otherwise have lost, Giroir and his colleagues say. "It reduced amputations. There was a 25 percent risk reduction in mortality and a highly significant improvement in overall functional outcome," Giroir says. "Although it was--quote--a negative study by narrow definition, reducing amputations by two-thirds is pretty positive." Doctors such as Giroir say that while they wait five years or more for another costly and lengthy study to be completed--if one even happens--more children who could benefit from Neuprex will be maimed or killed. "It's not available now," says Giroir, a clearly dedicated physician and just as clearly a frustrated one. "When it reduces amputations by two-thirds, and I can't even get it for compassionate use, then it's a big deal."<<<<<<<<<<<

To: Robert K. who wrote (16960)	7/1/2004 5:03:10 PM
From: Bluegreen	Read Replies (1) \| Respond to of 17367

Bob, it had subpart E designation. Why didn't the FDA follow their own guidelines on subpart E? Why was Girior left out? From the article I just posted?>>>>>>>Once death was eliminated as proof of the value of Neuprex, the stamp of approval had relied entirely on whether the secondary end point, the "composite," could show that Neuprex had a significant effect on meningococcal sepsis patients. Unfortunately, that composite was designed between the FDA and XOMA without Giroir's input or the input of any investigators. As a result, the composite secondary outcome was flawed and ultimately meant Neuprex would be rejected by the FDA. The dramatic reduction in amputations among those treated with Neuprex was obvious to doctors looking at the research results, but final results were lumped with many minor effects. The huge reduction in amputations was so buried by irrelevant conditions that the important benefit ultimately became statistically insignificant, Giroir says. "This is the essence of it. This is why the drug didn't get approved. Because the composite variable, the way they structured it, if you had knee pain and you had four extremity amputations, you were put in the same bucket, the same category," he says. "There was death, life and this intermediate category that lumped all kinds of things together. "If you look at the whole trial, we had a 68 percent reduction in amputations," he says. "Four kids with four extremity amputations in the placebo group. No kids with four extremity amputations in the BPI group. That's pretty compelling."<<<<<<<<<<<<<<<