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Caesare, I am so sorry to hear of your loss. I know that if I were to lose my wife, well, she's the best thing to have happened to me. As a long term member of this board, we tend to become a loose knit family, and although we really don't "know" each other, we still tend to feel the empathy for one another when we experience these life changing events. Best to you going forward!
Dr. Chan mentioned he was working on his investors letter during the Cowen interview. Well, if you're not a stock holder that would mean nothing, but his timing on that statement I am certain was meant specifically for us, he was saying we have news and I will deliver it shortly. Now, the approval could be all of it, or he could get into his plans and organization for dealing with the problems here. I would like to see a little space between the FDA approval, the Shareholders letter, (Maybe a week?), and Canada coming on line, a week after that, however I'll take it any way it comes. I wish Bertha was here...
Texting a friend, as we speak who is a contractor in Canada, he says that Canada pretty closely follows behind the FDA, that there is a good chance we could add Canada soon.
Lakersrback, Spectral is much too narrow a focus, also trading volume is so light that a sell order might take days to fill. Too risky, thanks anyway...
I remember comments made from a while, (couple years), back that Fresenius may not be the easiest company, partner, to work with. Don't remember specifics but they could be a little sharkey at times.
Canes16, No, No, don't misunderstand my response! I was looking for your GUT feeling on that, as I thought I understood your questioning the data coming out of China also! Speculation is usually based on perceived truths, your speculations are thoughtful and valuable to all of us, especially as seen through the lens of someone in corporate finance! My apologies, just an old veteran trying to stretch a meager pension! May you be surprised to the upside...
You REALLY think they have? Time for "Trust but Verify"?
Crcook, Fresenius did have their own filter that they were working on, but it never was able to perform as well as ours did...
Agreed Orangecat. 10-12 years ago we started out as a company with a product that would remove deleterious waste that the Dialyzer membranes were not capable of removing. It dawned on management that there was a much larger picture with this device, Sepsis was the big one, so the partnership with Fresenius was placed on hold and we concentrated on developing what is now the filter. I have always believed that Fresenius has had their eye on us but was waiting for us to get FDA approval before making their move. They have a reason for us not to enjoy spectacular results, as that would move the pps up and they would like to buy us as cheaply as they could. I think they could have done a much better job promoting us but they didn't. I believe Dr. Chan felt the same frustrations with Fresenius and that is why he made the exchange of sales areas from Europe to Mexico. Yes, Fresenius does have a large footprint in the USA. However, because of the less than stellar performance of the partnership, I would be more comfortable with GE. Unfortunately they have been selling a lot of their medical holdings in order to clean up a disastrous long term nursing care insurance debacle. Fresenius has a fishy smell to me. Just my opinion.
Regarding the question, Can a company charge for use of their product under the authority of EUA by FDA, all I was able to find was, under Sec III, Emergancy Use Authorizations, E. Conditions of Authorization, 3. Records; 3. Records
To the extent practicable given the circumstances of the emergency, FDA must establish conditions for a manufacturer of an unapproved product to maintain records and to grant FDA access to records concerning the EUA product.51 FDA anticipates that such conditions may relate to, for example, the number of doses, devices, or other unit(s) (including lot identification) that have been shipped or sold under an EUA; or the name and addresses of the facilities to and from which the EUA product was shipped.
Haven't found anywhere where is says we can't sell the product. That may be a condition or requirement pertaining to Trials. That would make more sense to me.
Murph... We can do a heck of a lot better than that!
Fully agree Techxen, seems the log jam is starting to break up. Dr. Chan did mention he was working on his letter to investors during the Cowen conference call. He is aware of what is going on and I'm hoping he is waiting to announce the timing of the release of the letter with FDA news. Something caught my eye on the Lou Dobbs, Politicization of Hydroxychloroquine with Dr. Oz. New York needs Nurses and techs who are trained in Hemodialyis Request can be heard at 9:10 point in the program.So, apparently many patients are hooked up to dialysis machines. Plug and play from this point...
NCT04324528
Freiburg University Hospital
Covid-19
ECMO vs ECMO + CTSO filter
Gotta be really sick to qualify; Mort: 83-100% Without filter...
Recruiting
Go Cytosorbents!
Stay Home, stay well!
Dr. Chan did make a slight slip and at first said 80 to 100 million (assume dollars) when he corrected himself and said, More than 80,000 devices a year... so now we know, maybe, 100,000 a year if all runs smoothly, or, 8300 per month. if the filter does catch on, we will need a lot more than that, thus, the talks with BARDA. GL all.
icmoney, Check the Cowen Conference call at 46:45.
https://www.netroadshow.com/conferencing/login?show=30cabb25&confId=15766
May be interesting with Covid!
Common sense would say a mix of sales and stockpiling, however if that were true then we would be operating at max capacity and Dr. Chan said no, we were not operating at max. It's got to be sales, mostly in Germany, data not out yet but I bet a large percentage of the serious cases are being sent to the University level hospitals and that is where you also find Cytosorb. Data will be out later. Wouldn't it be nice to know how many filters are being shipped to Germany! That is data that I thnk could be released without consequence. PM Boris Johnson is in ICU. I wonder if he will receive the benefit of our filter early on... GLTA
Pepe01, for a company as small as ours is, all these upper level management officers could make Cytosorbents a bit top heavy, especially if the specific positions tend to overlap in their job descriptions. That being said, any officers brought on say, as a MSL should have name recognition, as the technical aspects to our filter are not that complicated and could be handled by the intellect already on board. We do need a CMO to free up Dr. Chan. Should a MSL be considered, I would suggest the following person... OK, Hang onto your hats, keep politics out of this, and look at the degrees held before you shoot from the hip.... CHELSEA CLINTON.
Ditto, Cream floats to the top. Don't quit!
Canes, I agree with you, during times of peace, but we are at war! Literally! What do you mean we have no data? We have tons of data, it's just not formatted and presented to the FDA on a silver plate out of their cupboard. A cytokine is a cytokine it doesn't matter the origin, what matters is it's removal. So simple and also so frustrating. They can't let thousands of citizens die that could have been saved! This reminds me of the good we could do with sepsis... all the arms and legs we could save... you don't think the makers of artificial limbs might have a problem with our device do you? 85,000+ treatments and not one adverse affect. For crying out loud, FDA, wake up! Sorry, needed to get that off my chest, going out for a walk... Hope nobody coughs in my face... By the way, 4 out of 5 people I've tried to send e-mail to I get failure to send notices, including Governor Cuomo.
Dr. Chan is not in China and he can only comment on the information that he receives from the physicians directly involved with the treatment or trials. The only accurate? information that we have received from China was a few days after our box of filters arrived and were put to use on the front lines. That was a picture showing a thumbs up photo of health professionals PRESUMABLY leaving a patient who had been plugged into our filter. China will be nice enough to us so as not to kill the goose that lays golden eggs for them. For all I know, and believe me, that ain't much, those "professionals" in the photo could have been Engineers who just finished reverse engineering our filter. Dr. Chan is doing the best he can with the information
he's got. He is on our side. I missed the conference call, hope a replay is put up on our site.
Thanks, HadToHaveit, I would like to address you thought as to the not to "easy" use of the Cytosorb filter. Just in the city I am in less than 1 million people, there are about 30 Hemodalysis clinics. Each clinic has back-up dalysis machines, some clinics have older machines that still work, but are currently not in use. Each clinic has at least 1 RN on duty during clinic hours, along with LVN's and Hemodalysis Techs. These people are trained in blood perfusion devices which the filter is a part of. The priming of the filter and getting the blood flow rate is what they do. I believe with a little bit of extraordinary effort, a lot of the critical needs of the filters infrastructure could be met considering the percentage of those needing our filter is quite small relative to the entire picture. Not that it would be easy, but doable. Stay safe!
Thanks, Hemo, I would also prefer we get the help to expand our capacity to meet this crises in house. As Cytosorbents matures, we will grow into the expanded capacity as the indications grow along with the acceptance.
That would mean the FDA has approved us, imo. Question for the group, Do you think the FDA really are nasty enough to withhold approval because we stepped on toes or under pressure from big pharma? Really? If that were proven, then that could be considered manslaughter, at the least. Not what I would expect out of scientists... I do admit I'm having a problem getting my brain around their lack of communication regarding us...
Without FDA backing, can Dr. Chan send any filters anywhere? Who approves compassionate use? If we were to send filters to NYC, over the head of FDA, then we could find ourselves like Abbott used to say, "Now were in a fine kettle of fish"!
Good luck with that! I tried sending e-mail to Governor Cuomo regarding his brother and all the rest of the dying in NYC. This is what I got:
554: 5.7.1 <gov.cuomo@chamber.state.ny.us>: Relay access denied
a lot of other movers and shakers out there don't have puplic e-mail addresses available for contacts.
38 years! Congrats! If you figure out what works, let us know, ok? I suggested "Sleepless in Seattle" for movie nite, and she said, "Ok, what do you want?"
Wait til tomorrows close, she might start acting like May West...
Hammy, we are the same age, and if someone told me I was wet behind the ears, I would take that as a compliment! It may take a little time to become a member of the Ohana, In the mean time... A hui hau, Tutu...
Sabai, I have felt for years we have been fighting under a "wet blanket" trying to get the pps where it belongs. My guess right now...9-12 pps. Who would be most interested in buying Cytosorbents? Fresenius for one. It would be to the advantage of anyone legitimately interested in us to keep the price down until they want to make a move on us, and I think they are waiting for the approvals from FDA so they would not have to pony up the cash for the trials. Just my own thoughts... BTW, this will pop with any FDA approvals, don't sit on the sidelines for too long, you have been here a long time and it would be unfortunate for you to miss the boat. Again, only my opinion... GLTA
With a 30% jump in pps following a pr that 70 critically ill patients have used the Cytosorb filter, what do you think the pps will do when, not if, the FDA approves our filter for cytokine storm related to this Corona Virus mess. We are currently manufacturing the filter at close to if not 100% capacity, and I believe we are now selling what we make. Dr. Chans comment regarding support in my opinion is to outsource the manufacture of the filter to pick up the overload caused by this viral outbreak. We may need as many as 120,000 filters in the next 2 months. our capacity is currently 7500 to 8000 filters a month. The rate of infection is growing exponentially. Do the math.
Canes, I think I see a change in the attitude of all of the health care workers, and that includes the president on down. I believe the powers that be have been read the riot act by the front line Drs and statisticians, causing a change from a conservative approach to an aggressive plan. I hope so, looking at the problems facing Italy and Spain, all of us need to do our part to attempt to get a lid on this thing. Should our filter become a part of the solution, we must insist it be placed in service at the earliest opportunity instead of waiting for the patient to be standing at deaths door.
If this note is true, and I see no reason it wouldn't be, then sometime this week we will hear from Dr. Chan. If we hear from Dr. Chan, at a time when he must be extremely busy,it would be for a substantial development, such as approval to use the filter to reduce cytokine storm in the sickest patients with the Covid-19 virus, based on the data from the EU. Just my opinion. GLTA,
KC, I have also given Dr. Chan the benefit of doubt for several years as has most of us here, but the silence is deafening! Perhaps it is time to hire, or attempt to hire a recognized expert such as Dr. Scott Gottlieb, to represent or lobby for Cytosorbents, if he would accept such a position in the first place... I don't have a clue if he would be available, if we could afford him, but I do know one thing, when he speaks, everyone listens! We still are facing a problem of severe equipment shortages should this virus become uncontrollable, if it hasn't already, we can only do what we can, but there is room for improvement. Consider how the pps moved with Dr. Chan's appearance on the recent news cast.
Burnt... In a somewhat sinister way, this must be what it feels like to be lost at sea, the rescue planes and ships passing us buy as we wave and scream our heads off, yet for some reason, they all just disappear over the horizon, leaving us to our fate... Well, if we just keep making noise perhaps someone will notice us out here! In an effort to get the attention of those that might be able to turn this ship around, I offer a list of those members of Congress that should understand the severity of the situation. A polite note to each one can't hurt. All the MD's currently in Congress:
https://www.patientsactionnetwork.com/physicians-116th-congress
Come on Bertha, slap a few of them while they are sleeping! GLTA...
Fantom... My thoughts are Momentum... The market has taken a hell of a dump triggered by this Covid19 and the effect it could have on the world economy. I surf, and I have been caught up in waves that there is nothing you can do but "go over the falls". No discrimination... everyone goes... BUT, We have flotation, (CTSO), we have an answer to the wave that took us over the falls, so I believe we will pop to the surface a little quicker than the rest of the "surfers". I don't know if that makes any sense to many of you, but at my age, I consider my self lucky to be able to still surf at all. RIP Bertha...
Fantom... I believe that there are currently 39 members of Congress are MD's. Don't hold me to that, it's off the top of my head, but a note to them could stir the pot a bit, and certainly wouldn't hurt, especially at this time...
No Sabai, you were not who I had in mind when I said that. You did have an intelligent reply to one in your post 19665. I have family in Solothurn, close by? Stunning country! gl2u, Sabai
KC, Meaning full post! A lot of opinions here are garbage, we know who they are, but when a member of this board who uses reason has a criticism they wish to air, then have at it. Helps keep the perspective balanced with the food for thought. I am sure we are manufacturing the filters just as fast as we can, and in a situation like this I have thought about how to meet the demand, should this virus continue to spread. If I were CMO or CEO I would approach GE and the Gates Foundation, lay out our data, they already have the viral data, to address the critically ill right now and going out as long as it takes til the vaccines and other control methods put this scourge away. That's my 2 cents... thanks.
Sting... Every time someone mentions Bertha I am reminded of the pain of losing a member of our squad. For those of you who never served in the military, but looked forward to Bertha's posts, you now get a little inkling of what it felt like to lose someone who had your back. Not quite as intense, but the same gut feeling. I would like to see Bertha's wife, Angela's modest request granted by those of us that appreciated Bertha and his many years of "service" to us. RIP Bertha. https://www.gofundme.com/f/dwight-deters-hospital-and-funeral-expenses