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eskay1954

08/03/18 1:22 PM

#12698 RE: orangecat #12681

At the reputation of key clinical advisors, a protocol amendment was to expand the inclusion criteria, improve operational aspects of the patient screening process, enhance the rate of enrollment, and ultimately INCREASE THE APPLICABLE MARKET THAT CYTOSORB could address if approved. Changes were backtested to the patients' screening logs, and this amendment is expected to be approved this quarter by the FDA.I guess Chan is looking to expand label,I did not have time or feel well enough yesterday to do more DD on the topic!!