CytoSorbents Corporation (CTSO)

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Oh, there's data, but FDA doesn't speak German. European studies provide plenty of solid evidence, as do the 17,000 safe uses of CytoSorb worldwide (x-USA of course). Countless lives pulled back from the edge of death in ICUs elsewhere beyond all other known treatments. Fresenius and Terumo wouldn't put their sterling brands behind CytoSorb if these statements weren't true. But, alas, the FDA says "Do it all again, Chan, HERE!" As if humans were different if they were born on the other side of an ocean. Remember MRI imaging FDA approval, Pears? Ten years helping docs outside of the USA before the FDA said "yeah, sure, okay. You feriners were right." Geez!