is waiting for the inflection point
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I am cleaning them up.
Why can I not find and Authorization letter from the FDA like the one issued for D2000? https://www.fda.gov/media/136834/download
Hemo, I think the point is that compassionate use is on a case by case basis requiring an individual request to the FDA for each and every case. The D2000 has been granted an emergency use authorization which bypasses the overhead/red tape required by the compassionate use program. It puts the approval to use the device in the hands of the physicians rather than the FDA. That is a Big, Huge, Ginormous difference. The best, I tell you. The absolute best.
I agree that this is a huge step in the right direction to help Cytosorb get noticed. It puts extracorpereal blood purification on the radar. The fact that Cytosorb appears to be an easier, safer and more inexpensive solution than the D2000 should give it a huge leg up once it is available. Backing by Terumo also probably helped move the D2000 approval along quickly. We are already partners with Terumo in some EU countries though. Why no love from them in the US?
A more complicated Swiss made product is approved. Meanwhile a US product made in the heart of the US pandemic "hot zone" is not. You can't make this stuff up.
Let's add a plasma separator into the mix "The D2000 Cartridge is for use with plasma only and not for use with whole blood." You know, just to make things more complicated.
So damn frustrating. That cartridge requires the use of their Spectra Optia Apheresis System. The damn thing looks to be the size of a clothes washing machine and cost $75K+. I don't know much about it, but it sounds like it is then $2500 per treatment. Meanwhile the $1000 Cytosorb cartridge can be used in existing dialysis, Bypass and Ecmo machines. Has Cytosorbents been blackballed of something?!?
The paradigm shift is a far harder sell than I ever thought it would be.
Could it be the "Universal" health care system there plus the limited supply? A sad thought, but perhaps save the limited supply for those with means vs. those without?
Pain killers? OT: ACRX.
WTF. Of course, when I need critical medical care I look to my attorney for advice.
What a freaking crazy world. You can end up with ARDS from Covid-19 and receive Cytosorb treatment in in Mexico or even Russia, but not the U.S. The FDA denial of EAP for Cytosorb 5 years ago is a crime!
Thanks Texhxen. It is posts like this that help us frustrated long term investors stick with it.
Come on. It was a clunky internet interview, likely done with a webcam or phone. See the background? It was probably his back yard. Holding the filter up too long? He probably could not tell when he was on screen, the host was on screen or they had bullet points on screen. This was just an in the field kind of interview and to make any more out of it is just silly.
Enrollment complete in October though. So 5 months to find 30 participants.
WTF. Estimated 5 months to enroll 30 patients? In the current situation that make no sense. Get it done in a week!
That is really strange...
I agree. They wanted to put him on Remdesivir but could not because of his liver enzymes. ECMO simply buys you time for your lungs to recover from injury. That does not happen overnight. But, IMHO, Cytosorb has the potential to quickly restore hemodynamic stability, especially in a young otherwise healthy kid.
It just could be the high profile case we have been waiting for.
It sure as heck is one of the cardiac trial sites, so they would have adsorbers in stock for the trial. The school has been a scientific partner with Cytosorbents for many years.
Big pharma owns the FDA. Hedge funds manipulate small companies stock to churn a profit. Both stifle legit small companies that could bring life changing technology to the world. It is sad.
Thanks FDA! Just imagine if the FDA approved Cytosorb for EAP 4.5 years ago. It is an F'n shame. If it is proven to be an effective treatment for COVID-19 related ARDS, heads should roll at the FDA.
Not going to load the boat for sure. Been let down by this company too many times and I already have a pretty good position. I have a few other investments I plan to increase my position in. Also, unfortunately, my industry is getting crushed, so there is probably an 80% chance I will be furloughed next week.
Sorry guys and gals, but I hope it drops. Dry powder just hit one of my trading accounts.
I don't know about that fast. However, I think the Cytosorb registry really could help our cause with the FDA. Creating it could turn out to be a brilliant move.
I know for a fact she did one investors presentation by herself. I specifically remember because I thought is was funny when the mike was still hot at the end and she talked about some personal weekend plans. Also the way she pronounces some words with her accent bothers me a bit. LOL.
Bloch has done at least one presentation by herself. Chan is better.
Does anyone know if the $80 million manufacturing capacity was for 1, 2 or 3 shifts? How about the old facility. I wonder if it can easily be converted back to Cytosorb from Hemodefend?
Yep. I called. 6 figures of dry powder not available until tomorrow. You can thank me for the timing of this PR.
Signed closing papers on a property I am selling this morning. Funds should be available Thursday. That likely means positive new should break before I have access to the funds. ;)
Damn. you would think they would waive the VAT on a medical device. If not always, at least given the current situation there.
LOL. I love that. I never thought they were using the ATM recently. As I said before, fingers crossed, I am closing on two properties I am selling in 12 days. That being said, we will probably see a blast off before I have access to those funds. FML
I know a few on this board have shared info on Cytosorbents and Covid19 with various news organizations. I am am one of them.
There was a big spike in cases in Italy this weekend. I was impressed with Aferetica's initiative in bringing Cytosorb into the organ transplant space. I doubt the are idle right now and suspect news soon from them in Covid-19 situation.
Well, my timing and luck with this stock has been cr@p. I am closing on 2 properties on the 25th, cashing out some significant equity. With my luck, if it is going to blast off, it will happen before the 25th. LOL.
Cytosorb! The new weapon! Ready for takeoff. I have read it will take 12-18 months for Covid-19 to run its course through the world. Ramp up manufacturing now!
Tampa COVID-19 patient called CDC, cleared to fly anyway
The woman says they had masks with them and wore them as a precaution in Italy, and also used sanitizing wipes. But during the last few days of their trip, one of them began feeling unwell. They both got a plane back to the U.S., and the already sick woman noticed her health getting worse.
Once she landed in New York, she says she had a fever. The 29-year-old said she called the CDC to let them know where she had been and how she was feeling but, despite her flu-like symptoms and travel history, she says she was cleared to fly from New York back to Tampa.
I have been here 12+ years. In the penny years he was the fresh breeze in the doldrums of months long newsless drifting. I will miss him. I am so sorry he did not get to see CTSO progress to it's full potential. He was a great cheerleader for the company. RIP BerthaBlueFish. 61. Way too young..
Very sad. If I am not mistaken he was only about 60 years old, correct?
Sweet!
I have to agree. Not only has it hit countries where Cytosorb is in use, but it has hit physicians that are likely to be aware the device exists.