CytoSorbents Corporation (CTSO)

[pharmeng]

Where are you getting approval by US authority this June/July?

FDA approval is 1H 2017 at earliest. For cardiac surgery, the initial trial is 20 treated patients, 20 untreated, and plans to be be completed later this year. Expansion and completion of that trial could start end of this year, but would still likely require most of 2016 to complete. Then submission, I think even 510k requires 90 days for FDA to review. PMA probably longer (not as familiar with devices).

Even if they pursue EAP with a small sepsis trial. It would take time to select sites, start up, so probably Q4 2015.

Just guesses, but they have not historically moved very quickly on clinical trials.