Fantom... I believe you said it well with your observation that you got too optimistic. Over the years, I have witnessed what I perceive as what I can only describe as a vindictiveness on the part of the FDA against those that for one reason or another have "rubbed the cats fur the wrong way". In our case, the decision was made to approach Europe first, and apply for CE mark approval. It made sense, because we simply didn't have the money to fund a trial in the style for which the FDA likes to see. The thought was we would get a foothold in those countries that accepted the CE mark and fund the FDA trials as we could afford to do so. I think some feet have been dragging because we chose a different route other than the all mighty FDA. Several things came into play. One, we are a new concept regarding the control of several medical problems and we are going it alone as a very small company presenting this to the medical world. Two, we are not a pill, we are a device. Three, the bar was set very high by FDA for the path to approval for Sepsis because they were embarrassed once before by Ely Lily and their PILL Xigris. (see; Sepsis Drug Xigris Pulled From Worldwide Market - Medscape). The FDA is very good at not getting burned twice. Four, I am sure there are several large pharmaceuticals that are watching our development and the potential effect we could have as competitors on their bottom line in related research and the influence they could have with others. Lastly, I personally take solace that there are people here much smarter than I that have a finger on what is really going on, physicians, chemists, pharmaceutical professionals, that see light at the end of the tunnel for Cytosorb, and I trust my gut feeling that we are not too far off from success. (Trust, but verify?) I've held this stock ten years, eleven actually, I believe our perseverance will reward us. GLTA...
