CytoSorbents Corporation (CTSO)

[techxen]

Ping, there is a third possibility.... which is that they just filed it later than you projected. Your premise from a previous post:

"My guess is that their meeting with the FDA and subsequent IDE application filing was sometime between Oct 18 to Nov 8."

But as of the last earnings call on November 9th, they has only met with the FDA and were still in discussions:

"As an update to REFRESH 2, we met with the FDA and are in collaborative discussions with them, designed to drive final IDE application approval. The current trial remains focused on high risk valve replacement patients. And once we finalize our discussions with the FDA, we plan to have an update on the final design in the near future. And pending those FDA discussions, we anticipate the start of REFRESH 2 this quarter."

So it could be a reasonable explanation that these discussions took them deeper into November than you had originally thought, which would mean we would be right around now at the end of the 30-day window.

From reading the last transcript, the analysts peppered Dr. Chan with lots of questions about REFRESH II and the from his comments, it appears the company's challenge with the IDE is designing a trial with a primary endpoint they think will drive adoption in sales and reimbursement while demonstrating clear clinical benefit of the device and the causative effect of the organ dysfunction during or as a result of the surgery.

I guess the positive aspect of the trial design is that they are leveraging the clinical centers and ethics committees from REFRESH I and that they are similar protocols.

Interested to know your thoughts on this and whether you think this could be a possible scenario. Your second scenario (declined submission) I don't see happening but that is just my opinion.