Good Morning.
I was not the poster who was supposed to have met with Dr. Chan. I have never spoken with him; nor have I ever met him or anyone else at Cytosorbents. However, I do recall someone else did speak with him over the last several months and said he/she would update us.
Despite all the ad hominem negativity you may read on this board, I believe there are several potential short-term catalysts that could jumpstart this again.
1. Hemodefend: news of IDE submittal, commencement of the short study and potential FDA approval for this indication by the end of the year.
2. Direct Sales: Ramping up of direct sales should slowly result in increased sales and increased margins over the next few quarters. Given that most of the new sales force was hired and trained towards the end of 2019, it's not realistic to think that we'll see massive increases right away, but this strategy should pay off over the course of the year and going forward from there.
3. Remove study interim results should be reported out in July or so. Positive results could potentially serve to bolster FDA approval at some point, but more importantly, increase usage and sales in Europe and around the world for cardiac indications.
4. There is a potential for European agencies to widen the scope of indications, including "standard of care" designation for certain ones, including for clearing platelet-inhibiting drugs like ticagrelor prior to emergent cardiac surgery.
5. I think there's a decent chance they'll possibly pivot the FDA approval strategy away from Refresh 2 to applying for Breakthrough Device designation for the removal of platelet-inhibiting drugs (ticagrelor, others) prior to emergency cardiac surgery. If accepted, this would hasten, by far, the path to FDA approval with a widely-needed indication. Once approved for this indication, off label use would be possible for any of the other indications, including sepsis.
6. I think there's potential for a partnership regarding CAR-T/CRS study. A partnership with a major Pharma company would give us much needed exposure and could potentially lead to a standard of care treatment for CRS.
7. Potential for more countries coming online.
These are just a few of what I believe are potential 2020 catalysts. I believe there are others, although most likely longer term.
Despite the usual negative tenor of the comments on this board, there are plenty of potential positives here, albeit with some risk. It is quite natural for companies like this to be subject to risk and have to raise money at times. Although this management has missed deadlines time and time again, I believe they have been good at limiting share dilution as well as they can. Given the short-term catalysts, along with judicious use of the ATM and loans, I think they can manage dilution conservatively.
They may or may not stay up at night worrying about retail investors, but I would think they are certainly under enormous pressure to raise the share price for many reasons, including being able to tap the ATM at a reasonable price. Remember, also, that Dr. Chan has an enormous personal stake in raising the share price.
These are all may opinions only.
Good luck!
AI
