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"While the trial did not, with this sample size, statistically achieve its primary end point target of absolute reduction in mortality at 28 days, it did demonstrate beneficial treatment effects across multiple end points. The trial clearly showed that mortality benefit significantly increased as a function of the amount of endotoxin removed, as measured by the EAA™ assay. In addition, cardiovascular function improved and the use of vasopressors decreased. Based on these outcomes, the Company intends to consult with its clinical and regulatory advisors and then meet with the United States Food and Drug Administration ('FDA') to discuss its regulatory pathway going forward.", www.digitaljournal.com
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