Replies to post #24456 on CytoSorbents Corporation (CTSO)

[fantomphan]

My concern is we are running out of shorter term items to move the stock, and stock movement is what I'm here for. You will disagree with me, but we can no longer trust that Q3 will be all that great. Some investors have passed away and some others are starting to hurt from the waiting. Not whining, just stating the facts. You and I agreed we should have been in the mid teens months ago. After a delay, we were headed there (my opinion) when we got the double gut punch, the financing (and it can certainly be argued they made a good move doing it but the timing?) and the earnings and "Oh by the way, we lost that $3 million backlog". They have a serious credibility issue. Nobody thought $9.8 would be that number. So, what are we looking forward to now and when? Serious question. Sorry for the ramble.

[techxen]

We have learned with the FDA not to get your hopes to high (remember EAP?) so count me as one that also believes a trial will be necessary.

That being said, the company has an advantage of following in the path of Portola with the Andexxa approval. You can see from the comments during the last cc, that what the FDA is looking for has now been established - no second guessing. It sounds like the data from the trial from Hamburg already supports that surrogate marker of platelet aggregation, so I believe this will also be shared with the FDA.

"They've (Portola) 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. "