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We're Still Waiting.....
I was wondering what happened to Polyheme...the human blood substitute that the Trauma and military folks have been waiting on and found this news item:
The Associated Press December 19, 2006, 5:46PM EST text size: TT
Northfield to review PolyHeme study
Northfield Laboratories Inc. said Tuesday it will reevaluate late stage study data on its PolyHeme red blood cell substitute because of discrepancies in preliminary data.
The company said it received the results from its contract researcher, but found two discrepancies in the dates of death for patients in the study. Mortality is the primary measurement for the study. The company has to "unlock" the study database in order to make the corrections. The Food and Drug Administration has been notified and the study results will not be submitted until they are final.
Shares of Northfield fell $2.90, or 20.3 percent, to close at $11.42 on the Nasdaq. The stock continued to nosedive, plummeting $5.74, or 50 percent, to $5.68 in after-hours electronic trading.
Northfield said it is releasing the preliminary results. Those results are mixed, the company said, depending on population from which the data were obtained. One population involving those who were randomized and received some treatment that did not meet the necessary threshold, while others in the "per protocol population" who received the correct treatment and did not violate protocol, met the study goal.
"This was a logistically complex study with many variables and a high incidence of protocol violations. We believe these preliminary results in the per protocol population represent the clearest evidence to assess the potential benefit of PolyHeme in this setting," said Dr. Steven A Gould, Northfield's chairman and chief executive in a statement.
Company officials could not be immediately reached for further comment on the results.
PolyHeme is a human hemoglobin based oxygen-carrying red blood cell substitute used to treat severely injured patients who need blood when it is not available
In other words, we're going to wait a while longer............
ss
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'Revel in action, translate perceptions into instant judgements, and these into actions that are irrevocable, monumentous and dreadful - all this with lightning speed, in conditions of great stress and in an environment of high tension:what is expected of "us" is the impossible, yet we deliver just that.
(adapted from: Sherwin B. Nuland, MD, surgeon and author: The Wisdom of the Body, 1997 )
Education is the anti-ignorance we all need to better treat our patients. ss, 2008.
The blade is so sharp that the incision is perfect. They don't realize they've been cut until they're out of the fight: A Surgeon Warrior. I use a knife to defend life and to save it. ss (aka traumadoc)
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Hybrid Mode
