CytoSorbents Corporation (CTSO)

[techxen]

Any thoughts to this comment regarding the FDA approval path?

I missed listening to the conference call again so was reading through the transcripts. The version on SeekingAlpha I found is not as accurate with typos and punctuation so the excerpt below is from Motley Fool.

I don't know if this was just a slip of the tongue but Dr. Chan said it twice in the same discussion regarding the approval path. How can a trial not be needed for ticagrelor removal - is this an option considering the other sources of data they mention (REFRESH 2, TISORB, etc.)? Maybe I just read this wrong.

"We're now in the process of defining the regulatory paths for the therapy with the FDA, whether or not it's a 510(k) versus the de novo 510(k) or PMA. If a clinical trial is needed, competitors such as Portola, that was recently acquired by Alexion for $1.4 billion and PhaseBio that is a public company that is still in the clinical trial phase, they've established an FDA precedent, that surrogate markers such as platelet aggregation of Factor Xa activity can be used as the primary endpoint for FDA approval. And in the sub-study, in the paper coming out of St. Georg Asklepios Hospital in Hamburg, Germany, four out of five or 80% of patients treated with CytoSorb had a rise in the MEA or Multiple Electrode Aggregometry Assay that correlates with the restoration of platelets function giving us additional visibility that if we were to pursue a trial, that we could see benefits here as well." (emphasis added)

Thoughts?