CytoSorbents Corporation (CTSO)

[Canes16]

My discussion with Amarex:

"There is a way to make it happen. Hopefully he will contact me in the next day or two. I am sure he is very busy. IF their communication with the FDA was pre-COVID crisis the FDA would not automatically recognize the application for their product...the FDA is being hammered and they are likely only paying attention to people who are proactively presenting specific approval requests."

"Based on the comments D. Chan just made....it appears that they are on top of it.....i.e., the Compassionate Use approach. One thing they may need to push it through is to submit an IDE amendment with a COVID protocol. That is what we did with our other client. The FDA already gave us feedback to refine the protocol."