CytoSorbents Corporation (CTSO)

[pearsby09]

"Not sure, but have begun to believe that Chan believes proving things in the USA can be expensive and, knowing their device(cytosorb), where they have obtained approval outside USA, and where they see a larger market than USA, why not concentrate in Europe(and elsewhere where they are accepted)."

They have concentrated on Europe for 9 years. They are losing money while the revenue in a MULTI-Billion dollar Market, against growing overhead and multiple trial expenses, which by the way, are very under powered ...hence a few hundred K per month, in a MULTI Billion Dollar Unmet Disease state! As for the USA, show some large Scale, Muti-Centered Trails, placebo controlled trials. The FDA is far more scrutinizing than the EU. The EU Excepts surrogate markers, the FDA wants cause and effect with concomitant Safety in LARGE NUMBERS!! Even the EU, with their surrogate approval and so called adoption can only hit a few 100k per year..The USA, with Chan's short cut tactics...will be far worse than the anemic/snail pace adoption of the EU..post many years! Bottom line, the EU has weak standards and weak production....The FDA has high level cause and effect and scrutinizing POC with NO Acceptable CHAN short cuts,,,which has been his plan for the last 9 years!