Replies to post #7039 on CytoSorbents Corporation (CTSO)

[ping_pow_princess]

Thank you for your comments. I came to be aware of MSBT in 2009 from an article...from Tapebeat, I think, not 100% sure. The article was later retracted and then rewritten due to an error about when clinical data from the trial would be presented. My main background is in information technology. A randomized controlled trial that shows statistically mortality benefit would be huge as all sepsis trials have failed in the past. Xigris was pulled off the market worldwide in 2011 after their study showed that Xigris did no better than placebo in reducing mortality. The drug was approved in 2001 by the FDA after a small trial. The Spectral/Toray trial using Toraymyxin device is currently running. I think CytoSorb will get EAP designation and FDA approval this year, thus shifting the focus on post market study.

[ping_pow_princess]

Unfortunately, I have been unable to post anything on Yahoo the last few days, not even basic sentences. All I get is "Failed to Post" when I am on Yahoo. Here is my response to your Yahoo question,

CytoSorb for cardiac surgery would not go through the EAP. Cytosorb for critical care use would be pursued. So, my interpretation would be the same as yours. We would see FDA approval for CytoSorb in the US for certain conditions. This is the "safe" Dr Chan wording.

But it may be that CytoSorb gets approved based on cytokine reduction then CytoSorb can be used in any situation or condition where cytokine levels are elevated which means cardiac surgery as well. We may not have to wait for the REFRESH pivotal trial to see an FDA approval in cardiac surgery. Getting EAP would be a big deal when it comes to partnership talks. Not only for CytoSorb but for HemoDefend. Investors' value FDA approval is greater than it would be for CE Mark.

Your question:

How do you interpret this statement from the recent shareholders letter. I was wondering if it means that CTSO could garner FDA approval for cardiac use and use in the ICU for sepsis at the same time. Thanks

As we move forward with our REFRESH cardiac surgery trial in the U.S., we plan to aggressively pursue this EAP opportunity for critical care applications in parallel, and foster open collaboration with the FDA