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"We felt, and continue to feel, that to do another study of meningococcemia would be very, very difficult to do because frankly there was nothing we could have done to accrue patients more quickly," Scannon says. "In other words, there is just a certain amount of paperwork it takes to legally conduct a proper clinical trial, and so it wasn't as if looking back on it we hit our hand on our forehead and said, 'Oh, my God, we could have done this better.'
"When the drug is approved and you don't have all this paperwork, it can be used as soon as the person hits the door. In fact, it could be used before they left Tyler, Texas, because it could be in Tyler, Texas, too," Scannon says. "In a clinical trial setting, we couldn't put Neuprex everywhere in the world. We had to take our best guesses and put it wherever we thought it should go."
Sitting in his office almost two years to the day since the final results of the study were made public, Brett Giroir recounts the efforts to get Neuprex into the hands of doctors everywhere. He is clearly just as convinced that Neuprex has a profound effect on meningococcal sepsis now as he was after Tashica was infused with Neuprex seven years ago.
"There were people who believed that based on those data the drug should have gotten some kind of approval," he says. "You have a drug that may or may not work, but it has no side effects and the alternative is no arms or no legs or a dead child? Yeah, I'll take that compared to all the other really experimental things we do in the ICU to try to rescue these kids."
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