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Re: dr_lowenstein post# 3200

Friday, 08/26/2011 8:50:43 PM

Friday, August 26, 2011 8:50:43 PM

Post# of 27409
I think everyone is forgetting the guidance already provided during the initial phases of the trial. Everyone complained primary endpoint was not updated but the following guidance was:

Seven of these patients were treated with CytoSorb? and standard of care therapy, while six others were in the control group receiving standard of care therapy alone. We are encouraged that an analysis of the data demonstrates improvements in many of the secondary and exploratory endpoints of the trial in the treatment group compared to the control group including:
· 28-day and 60-day all cause mortality
· Ventilator free days
· Pace of ventilator weaning
· Organ failure scores
· Vasopressor use
· Days in the intensive care unit
These objective endpoints in the treatment of severe sepsis are important. First, improvements in these key outcomes are difficult to accomplish but are directly associated with improved patient outcome and survival. Secondly, these are parameters used by critical care physicians to judge how patients are doing and are predictors of length of stay and cost of stay in the intensive care unit. Lastly, improvements in these criteria are consistent with how CytoSorb? is intended to work.

Add the primary data we received with CE mark approval to this data to get a clearer picture.

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