CytoSorbents Corporation (CTSO)

[pearsby09]

I will step in. The EU granted surrogate approval (cytokine attenuation Only!). They did not have to show Morbidity/Mortality data to win approval. The FDA is a whole different animal. The FDA traditionally requires large scale well designed trials that demonstrate efficacy(Surrogates/Morbidity/Mortality) and Safety. To date, Chan has begun an equivalent P2 in CABG (Refresh 1) and is proceeding to P3 equivalency (Refresh 2) in several months. It will take the completion of this type of trial and perhaps a second P3 level trial for confirmation. The P2 and P3 are not device definitions. So to answer your question, we are more than 2.5 years out for FDA approval...If the R2 data is positive. Chan could be much further along in the FDA process if he was not the King of Short cuts and Shot guns. There is a possible short cut....EAP, but I believe the FDA is not willing to grant that based on anemic data for Morbidity/Mortality...unmet disease state or not. So, it is the EU that will generate any foreseeable revenue for the next several years. Your...Beloved...Pearsby