Replies to post #6983 on CytoSorbents Corporation (CTSO)

[ping_pow_princess]

At the Needham conference, Dr Chan talked about softer clinical endpoints such as less days on ventilator. So, it's just not iL-6 reduction. Don't overfocus, look at the big picture and intended purpose of the EAP which is to get a safe and effective potentially life saving product sooner on the market. The focus shifts to post-market data.

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The CytoSorbents Needham presenation, slide 40:

"Advantages of EAP Designation

The first step is to submit an application to the FDA to request EAP Designation.

If successful, this has a number of advantages:

• CytoSorb® would be given priority status and be assigned an FDA case manager which would facilitate future discussions with the FDA

• Valid for both PMA and De Novo 510(k) paths

• Shifts Premarket data collection to the post-market setting with the appropriate safeguards for safety

• May allow for the potential acceptance of softer clinical endpoints to justify approval, in anticipation of more conclusive post-market data on endpoints such as mortality

• 30-day review of the application

This program is designed to facilitate early and faster US regulatory approval of
potentially life-saving medical devices. We believe this squarely applies to the core of
our critical care strategy at CytoSorbents. As we move forward with our cardiac
surgery trial, we plan to pursue this EAP opportunity in critical care applications and
foster open discussions and collaboration with the FDA."

[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.