CytoSorbents Corporation (CTSO)

[orangecat]

The FDA Breakthrough device program guidance says that the program replaces the EAP program. Cytosorb did not get EAP because the FDA did not want to accept surrogate endpoints for a sepsis trial. After the denial, Dr. Chan stated that any US sepsis trial would be granted fast track status so there is no benefit to the EAP program without the surrogate endpoints.