CytoSorbents Corporation (CTSO)

[ping_pow_princess]

I'm not sure about June/July but we would most likely see FDA approval in the sepsis condition sometime this year. The EAP program went into affect April 15...but the company would need time to draft their plans and prepare a submission for the EAP program. CytoSorb is suitable for EAP designation. The FDA responds to the application within 30 days. If they have further questions, it may take longer. Before approval, the FDA would like to see reasonable assurance of safety and effectiveness for premarket. CytoSorb has already shown that it is safe and has saved lives. Having CE Mark approval and already being marketed in Europe, Asia and planned expansion into other countries will certainly be factored in. I'm interested to see how they will obtain the clinical data as part of the post market data collection. Whether entries into the CytoSorb registry will be sufficient or they would still have to obtain data which they can probably get from the planned EU sepsis study later this year.


"FDA Response to requests for EAP designation

The FDA intends to notify the sponsor of its determination in writing within 30 days of receipt of a request for EAP designation.
If there is insufficient information for the FDA to make a decision about EAP designation, the FDA may request the sponsor submit additional information.
In response to such request, any additional information provided by the sponsor should be submitted as a supplement to the Pre-Sub.
If the FDA requests additional information from the sponsor, the FDA will notify the sponsor in writing whether or not EAP designation is granted within 30 days of the date of the request for additional information.
If the FDA has not received enough information in time to make a decision by 30 days after a request for additional information is sent, the FDA intends to deny the EAP designation."

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/ucm441467.htm