This is from the last shareholder letter, "The expected initiation of our U.S. cardiac surgery REFRESH 2 trial in the second half of 2017, pending FDA protocol approval, would establish a timeline for U.S. approval (potentially as early as 2020) for the first time. "
From the last 10K, "The Company has recently met with the FDA regarding REFRESH 2, intended to be a pivotal, registration trial for US approval, to discuss trial design and address any clinical and technical questions. In parallel, the Company initiated discussions with previous trial sites that participated in the REFRESH I study that are familiar with the CytoSorb device and intraoperative use during CPB. The Company believes using sites that previously participated in REFRESH I will accelerate the process of site startup and a planned fourth quarter 2017 launch of REFRESH 2."
I believe they have already submitted in their IDE application when they mentioned this: "Meanwhile, we are working diligently to initiate our U.S.-based, REFRESH 2 cardiac surgery trial by the end of 2017. This pivotal, registration trial is designed to support U.S. regulatory approval of CytoSorb for complex cardiac surgeries like valve replacement. We have already met with the FDA to discuss our proposed trial design and will provide an update when we have more information on our investigational device exemption (IDE) application."
The FDA has 30 days to respond back after an IDE application submission. If I recall from the last conference presentation on Oct 10, they had not had their meeting with the FDA. Taking into consideration when this was reported on Nov 9, the maximum date that CTSO would hear back from the FDA is about Dec 9. So 30 days from IDE submission, means CTSO would hear from them any day now since we don't know the exact day of submission but have an idea the latest would be Dec 9.
