CytoSorbents Corporation (CTSO)

[ping_pow_princess]

You state that "Thus, I have a harder time believing that reduction of IL-6 will be accepted as a surrogate endpoint."

FDA had already approved an IDE for a 30-patient study amongst trauma patients with rhabdomyolysis where the primary endpoint is myoglobin removal. If it is for sepsis, reduction iL-6 would be no different.

https://clinicaltrials.gov/ct2/show/NCT02111018?term=NCT02111018&rank=1

The US Air Force funded this pilot study. In the company's PR announcing this, they have this: "As part of the IDE application process, the FDA has reviewed the CytoSorb® treatment safety data from the European Sepsis Trial. We believe this early review of the European Sepsis Trial safety data will help streamline our future discussions with the FDA about a planned U.S. pivotal trial in sepsis."

http://globenewswire.com/news-release/2013/06/17/554439/10036517/en/CytoSorbents-Announces-FDA-Approved-US-Air-Force-Funded-Human-Trauma-Pilot-Study-for-Rhabdomyolysis.html

Originally it started out with an SBIR grant from the US Army to evaluate the technology for cytokine and myoglobin removal in the treatment of burn injury and trauma with the added bonus of developing "a portable, robust, and logistically-friendly blood purification system that combines a state-of-the-art battery-powered blood pump". Contract W81XWH-12-C-0038.

https://www.sbir.gov/sbirsearch/detail/414744

So taking into considering this information and in my first post in response to this, I see no reason why the FDA would not allow CytoSorb EAP designation and have IL-6 reduction as endpoint. Safety has been proven. CytoSorb is already marketed in many countries.