Replies to post #10334 on CytoSorbents Corporation (CTSO)

[ping_pow_princess]

I do not know if they are selling at the market. All I noticed was this jump in volume but not in price when throughout the day, the movement in bid and ask was in very tight price range. There was alot on bid at 6.20 and not very much at 6.25.

I think they have a very good idea from the FDA meeting what the protocol will be and how many enrollees are required for the cardiac surgery. They had to write up the IDE application submission after their FDA pre-submission meeting. It's a formality of the FDA approving the IDE Application within 30 days in this case. Dr Chan is pretty confident that the REFRESH 2 will start this quarter. I think they want to raise enough money to cover studies for other products in the pipeline as well as cover some loan repayments. There maybe a potential partnership deal for the cardiac surgery but I think it will be signed and announced next year.

I've include the link on the IDE approval process:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#fda_action