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."<<<<<<<<<<<<<<< |
