CytoSorbents Corporation (CTSO)

[orangecat]

I would not jump to the conclusion that they are struggling or delayed. There is certainly more work to an EAP submission than filling out a few forms. The early approval is granted if the device has a good safety record and a likelihood to prove an effective treatment. Post-approval data collection is required to confirm the safety, efficacy and effectiveness. Creating a data development plan for the post-approval data collection could require a significant amount of work. It would be really nice if the FDA would accept the registry data for the post-approval data collection.

From the FDA's guidance:
"In addition, FDA intends to work interactively with the sponsor to create a data development plan specific to the device (“Data Development Plan”). The Data Development Plan should outline all data the sponsor intends to collect in support of device approval, including what data will be collected premarket and postmarket."