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Re: pearsby09 post# 10411

Thursday, 11/30/2017 11:23:17 PM

Thursday, November 30, 2017 11:23:17 PM

Post# of 27409
Thirty days for the FDA to respond back to company's IDE submission. My guess is that their meeting with the FDA and subsequent IDE application filing was sometime between Oct 18 to Nov 8. So by end of next week latest, we should know. Would make sense to time the news for the Dec 5 morning. In between, there could be news about the Italy launch of the Perlife system. Following that if they plan significant cash raising, it would most likely be done before Dec 22. However, they may continue to do the "at the market" (ATM) dilution so that it is not so noticeable to shareholders.

REFRESH I IDE submission (Dec 30, 2014):
https://www.prnewswire.com/news-releases/cytosorbents-submits-ide-application-to-fda-for-us-cytosorb-cardiac-surgery-trial-300014434.html

REFRESH I IDE approval - (Feb 2, 2015):
https://www.prnewswire.com/news-releases/cytosorbents-announces-fda-approval-to-commence-initial-us-cardiac-surgery-study-300028992.html
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