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HadToHavit, Yes, I have seen what appears to be this type of thought process, especially while listening to question and answer periods during quarterly presentations. I would tend to agree with you, especially if the developing party has adverse problems or liability from FDA or trial data directly attributable to their design or a problem they failed to foresee. In this case, a natural reaction to the administration of a new product, even though it could fall into the second category, failed to foresee, is still a natural reaction and certainly not something to try to hide from competitors or constituents. This is the reason for trials in the first place. I would see the inclusion of the Cytosorbent filter as a natural add on for the treatment of an extreme reaction. I see this as a positive fix and support for CAR-T development.
BG Man, Welcome to Cytosorbents... The big question on, I'm sure, many long term investors minds of Cytosorbents, Inc., is why haven't we heard of any interest from the leaders of CAR-T cell research regarding the potential benefits of using the filter during episodes of cytokine reactions to the administration of the t-cells. I am sure the answer is not an economic question, as it would be to the benefit of all, especially a lab, to take the forefront of this developing science. Is it simply a question of FDA complications for the development plans of the pharmaceuticals to include our filter in their designs? Perhaps the inclusion of our filters at this point in their programs would complicate the results beyond what the scientists are willing to do, although this would not be the first time that progress and new developments would allow for the inclusion of modalities added during mid-course of trials and research. There are those on this board who are much better qualified to answer these questions than I. It remains a head- scratcher why we have not heard our name mentioned by the leaders of this new science as an obvious, effective fix to the cytokine storm complications. Good luck to you, you have chosen to invest in an exciting company, cutting new avenues in treatments in the field of immunological response.
Search Anna Norquist from South Bend, Indiana. Another one of 200k or more that could have used our help. One leg, one arm and more to go! Come on FDA, I saw the 1 million $ price tag on this woman. No excuses!
This post sounds legit... Sorry for your heartache Murph... There is so much going on regarding Cytosorbents' filter that I don't understand the way this filter has been treated by the FDA for the past several years. Thousands upon thousands of people have been forced to endure suffering and life long hardship because the FDA refuses to take a serious look at and appropriate action with our filter. I estimate 150k people lose hands or feet annualy and I believe many of these could be saved, not to mention the loss of lives. Since there has not been ONE adverse effect of this filter in over 51,000 uses, the 28 day mortality test should never be considered or come into play in the decision making process.
Well said, Eskay! I also want to congratulate you for not misspelling one word!
Bertha, I look forward to following up on your posts as they guide us toward further knowledge and understanding of the mechanics of biological processes, especially as it relates to cancers and infections that have a dramatic effect on the human immune system. I assume there has not been a publication such as, "The immunological Guide for Cancer and Infectious Diseases for Dummies?" yet? Keep up the good work, you are helping to keep the brain cells firing!
Andi, Bertha; It seems our filter can have beneficial results with many different afflictions, anything that substantially raises the ire of our immune system, however there seems to be several diseases that this filter is especially good at controlling the immune response. Take case #47, 2018. Liver disease would be a HUGE market, and if most of the results are similar as this latest result:
Conclusions:
• The use of CytoSorb in combination with continuous renal replacement therapy in this
patient with fulminant liver failure resulted in a marked improvement in renal and liver
function along with efficient and sustained reduction of bilirubin and ammonia
• According to the medical team, CytoSorb therapy is much easier to handle compared to
treatment with established liver dialysis systems
• The installation of the adsorber into the CVVHD circuit as well as the application of CytoSorb was easy and safe.
Alcoholism takes a terrible toll on not only the sufferer but also the families of the patient. I understand why the medical profession and underlaying insurance industry is hesitant to keep the rotating door policies going, however, what if with Cytosorb coupled with the transplantation of Antibuse were to be offered as a contract to the patient, then the problem of relapse would be resolved and governments would be much more inclined to offer this solution as the patient would be unable to imbibe in alcohol consumption. Unethical says the do gooders? Nope, simply terms of a contract that the patient could accept or reject, their choice. Of course, the Antibus would be implanted in a place that the patient could not get to and remove on his or her own. Just a thought...
HEAR! HEAR! And a TOAST to Burnttoast! Happy Thanksgiving!
Very good day today, first time pps has risen over $1. Lets hope we can gain a little traction and at least hold this position if not add to it this week.
Burnttoast… Looking at the 3 month daily chart, the last 2 weeks or so looks like a Richter scale that is getting ready to blow. Good news is stacking up! Agreed, excellent news posted by Andy... More to come...
So... Dah... have you told the wife what the pps is this morning? Lol... and if you did, is she chasing you around the house with a frying pan? No worries, the exercise will do you good! I think you might buy her a nice bouquet before letting her know! Was a good trade just the same... I tried what you accomplished and failed miserably, never got close to my buy point.
Congratulations Dah! Good move, your up 3500+ on the trade, tomorrow you will close over 5000 for the trade. I am all in, have been for years now, basis, just over 4 on 31000+ shares. From the call, the highlight for me will be the fact that Cytosorb will become the standard to turn to with any signs of CRS over steroids because of it is superior functionality and least detrimental effects to the CAR-T treatment. This will become apparent quicker than you might think as soon as the numbers start flowing out of the institutions using the filter for their cancer patients. There is nothing stopping physicians from using our filter in the EU right now, and they will. Any positive numbers and this is going to move to the up side in the blink of the eye!
Over 35,000 shares traded in blocks of 1000 or more in the last 20 or so minutes. Seems a big shot or two might be interested in Dr. Chan might have to say.
Hopefully when they receive the Margin Call...
Good Sport, I was in the process of replying to your statement about vaccines, when you erased your post. Let me say this about Vaccination: Smallpox, gone,... Polio, almost gone, just a few pockets left in this world. I am a cancer survivor, and you can be sure I will get my Flu shot next week, as the alternative for me would not be very pretty, and I don't think my doctors would hook me up to my Cytosorb filters even if I demanded it, for several reasons. One more question. If you really don't hold much faith in todays modern medicine, why have you invested your hard earned money into this?
Good Sport... I understand your frustration, however, the intent and goal of the letter is not to confront which slams doors closed, but to suggest a path that could be helpful to their constituents welfare in a rather dramatic fashion. One or two inquiries from a Congressman who is also a doctor could sway the way that FDA looks at our filter. That's the goal. Of course, we don't mention the benefit to them for being the first to free up this treatment to their constituents in need. That would be obvious to them. I would simply bring this new therapy to their attention asking why it has not been approved, and including Dr. Chan's contact info in the letter. Short and sweet. They are pressed for time...
From my poet 13706;
The FDA had their chance when we applied for the EAP Program. Our application was turned down by the FDA because we were targeting Sepsis, and they had recently been burned by Eli Lilly, when Lilly voluntarily pulled the Drug, Xigris. "Eli Lilly is withdrawing activated drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality." From this point forward, the FDA arbitrarily insisted that all treatments designed to treat Sepsis be subject to the 28 Day Mortality Test, even though this requirement flew directly into the face of the intent of the Expedited Access Pathway Program. There are currently 15 members of Congress who are Physicians. They do respond to constituent letters. A polite note to them inquiring why Cytosorbents filter was turned down by the FDA for the EAP Program, given its successes in the EU, is well worth a closer look. Here is the list of Physicians in Congress:
beckershospitalreview.com/hospital-management-administration/meet-the-15-physician-members-of-the-115th-us-congress
WOODLAND PARK, N.J. — A 10th child died Wednesday night from adenovirus after an outbreak at a New Jersey long-term care center that has infected 27 medically fragile children, the state Health Department said.
“The loss of these young lives is heartbreaking, and our thoughts are with the families who are affected,” Elnahal said of the death. “We are working closely with the facility to conduct respiratory illness surveillance and ensure all infection control protocols are continuously followed.”
All of the children infected in the two outbreaks have severely compromised immune systems, the Health Department said.
Well... When do we try to save these kids?
Regarding the speculation lately of the stock price for Cytosorbents, I have looked at the relative movement of CTSO with several other holdings that I have or are following, and if you overlay the YTD charts, in my case, RIG, FB, EXAS, CAT, ISURG, even the $DOW, they all follow the same general pattern. True, CTSO is a smaller company and therefore subject to wider fluctuations than others, however, I think it is pretty obvious that the pps movement has been mostly influenced by the general fluctuation of the market as a whole, with a bit of "pile on" by the shorts, praying to get out of their position, which in this case, they won't. :)
Within the text of the 2nd Quarter announcement it was stated, " CytoSorb® has been used in more than 40,000 human treatments to date." This is approximately 5000 filters used between the 1st and 2nd quarters. "Q2 2018 product sales were a record $5.2 million." This quarters announcement states, " CytoSorb® has been used in more than 46,000 human treatments to date." That's a use of 1000 more this quarter than 2nd quarter results. That could mean product sales could exceed 6 million dollars in sales, +/- 1/2 million. That puts us over break even, from just over to well over. (My best guess). Congratulations, Dr. Chan!
"Chanie is fine a real trial is the problem. Our lack of a proper RCT or randomized control trial is the problem here is gaining real traction. Sure, I'm quite almost certain this product has rock-star efficacy, but the docs need the hard-core proof and that only comes by way of a solid RCT. Heed the call and do a large raise and let's get a solid septic trial on the books!"
Lakersrback… I am real impressed with the progress you have made in your study and innate ability to go from a person who blindly invested his down payment for his new home 8 weeks ago to an individual who understands the nuances of investing. "Proper RCT", "rock star efficacy", or a "solid trial on the books. My, my... and your quickly gained familiarity with our CEO, Dr. Phillip P. Chan, "Chanie" to you now! I am having a little problem remembering who it was who used to call Dr. Chan, "Chanie". Maybe you could tell me? Now you have averaged down. Good move! Based on what? What's next, Pearsby?
The FDA had their chance when we applied for the EAP Program. Our application was turned down by the FDA because we were targeting Sepsis, and they had recently been burned by Eli Lilly, when Lilly voluntarily pulled the Drug, Xigris. "Eli Lilly is withdrawing activated drotrecogin alfa (Xigris), a drug intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality." From this point forward, the FDA arbitrarily insisted that all treatments designed to treat Sepsis be subject to the 28 Day Mortality Test, even though this requirement flew directly into the face of the intent of the Expedited Access Pathway Program. There are currently 15 members of Congress who are Physicians. They do respond to constituent letters. A polite note to them inquiring why Cytosorbents filter was turned down by the FDA for the EAP Program, given its successes in the EU, is well worth a closer look. Here is the list of Physicians in Congress:
beckershospitalreview.com/hospital-management-administration/meet-the-15-physician-members-of-the-115th-us-congress
IMO, I think the drop in value can be attributed to a top at 14.95 coupled with a sophisticated, moneyed investor or group, doing what they can to load up on other peoples shares, knowing that if we cross that line of break even this next quarterly there could very well be another beginning to a strong run to the up side. For the past week or so there has been downward pressure and every now and then some rather large blocks going by indicative of a group or person scooping up nervous nellies shares. I don't believe there is any news that is going to cause a problem here, if so it would have shown up a long time ago. Steady the course, going up down the road, in relatively short order.
Who's Keith?
Not to mention the 150,000 or so hands and feet that could be saved! Think about that... 150,000 people going through life without hands or feet because a filter had to pass the 28 day mortality test because a government agency was embarrassed when a pharmaceutical giant recalled a pill when it was determined the financial exposure to side effects was too great a risk to their bottom line. Unbelievable!
Lakersrback, Pearsby was (is, maybe?) a dear friend on this board that kept us entertained with his soft bash or extreme buy scenarios that he would ply us with depending on his position at the time. Now, Grasshopper, since you have tugged at my heart strings, allow me to help you see this stock a little more clearly, tactically. Open up your brokerage account and go to your daily chart, open it up to 440 days. Ok, upper trend line first. pick a color and start this line from 3/31/17 and click it at the highest point the stock reached that day. Now move your line to 9/24/18 and picking the highest point there, click it again. This should give you the upper trend limits. Ok, go back to 3/31/17, pick another color and starting at $3.40, extend another line to the $10 point on 9/24/18. Click it. This should now give you the lower line of the trend over 18 months or so. OK, now you can see where you bought, ($14), perhaps the stock was over bought as it was above the upper line. To make it easier you could place a dotted line splitting the two parallel lines. Buy in the lower half, sell in the upper half and you should be ok. You could also trade the stock and over time gain back your lost money if you keep in mind the momentum of the stock as you trade. Very basic, very simple, good luck. Some day this will go through $50 per share. The market is a bit more resistant to a device than a pill. If this were a pill, we might be in the 50-75 ranger right now. Ok, enjoy your day. PS; yesterday was my birthday, and this is my gift to you! Good Luck!
Hey! Pearsby! How you been?
Good ear, Aliberto… You are correct, at 25:05 in the presentation, Dr. Chan does state that we achieved $600,000 sales in one hospital this past quarter. I would be willing to bet that it is the Jena University Hospital that is the facility that has been leading the sales volume, and I wouldn't be surprised to see them report numbers well into $600k this quarter. Should achieve break even and then some this quarter also.
Yes, he did Orangecat, and if product sales across the board show only 1/2 as much volume increase, we will blow through the break even point in sales. That was a huge hint of sales moving up in the near future... We are beginning to gain traction, finally!
Techxen, I don't know how you find these nuggets, but this one is really good! I watched it twice, and from set up to turning on the blood flow, to filling the Cytosorb filter and the shot of pure blood leaving the canister, each shot is informative, especially the beads as the blood moves thru them. You need a new name tag...
"Professor Techxen"
I glad you're on our team. Thanks!
Isn't he on the East Coast? Possibly very busy with Florence... Ping has been quiet also, though she usually comes up when there is company action going on and members of this board needs clarification...
Not sure if this has been picked up yet, Keytruda/chemo in 1L-NSCLC converted to full FDA approval based on OS/PFS in KEYNOTE-189 study, (Merck & Co. Inc.) August 20... Warnings included as follows: Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Opportunities abound...
Techxen… You and Bertha remind me of favorite professors I had a long time ago. I would look forward to going to class because I felt I had nailed a paper or had an opinion that looked at a subject matter differently than what was presented and I would walk away after confidently stating my thoughts, and having a spirited back and forth banter, knowing that I had been eloquently nudged to dig deeper, having been given the tools to do so. Ah! More work to do! Bravo on you two!
Idunno, I believe that would be short-sighted on the part of Cytosorbents, and also think that Dr. Chan is not going to paint himself into a corner regarding opportunity down the road. We have no idea what beneficial avenues the competitive laboratories are working on. I believe it would hurt us to tie our wagon to a specific horse rather that offer a better wagon for all the horses in the race. Imagine, if we entered into an exclusive agreement with say for arguments sake, Microsoft, when they were financially helping Apple to stay alive, and fast forward several years to today. The opportunity lost would be horrific for us. Besides I think our product should be shared with all people who need it in a timely basis, no matter who's art is the primary therapy. No, I would like to see our modality remain available to all companies that would benefit with the pairing of our technology with theirs. In time I can see our filters physical make up designed specifically for particular disease states and needs for specific immunological illnesses. Exciting times ahead...
Bertha, Novartis is now approved for CAR-T in the EU. We are approved in the EU. There is nothing stopping Novartis from using our filter during the application of their therapy, especially when the patients immune system flares up to concerning levels. I am being lead to believe that our filter is more effective that steroids for the control of the immune response, as it relates to the effectiveness of the therapy. Dr. June is the communication link between Novartis and us. Dr. Chan will in a few days be sitting on a panel discussing the treatment of cancer. Gee, I wonder what he might have to offer... Things are getting very interesting. Has our stock ever been halted pending news? Would an announcement of a partnership between Novartis and Cytosorbents justify a temporary halt to trading? We could find out... GLTA
Refreshing finish today for once! Either a short position closed out or someone with a couple of nickels wanted in before Monday... Either way, made for a decent close today! News brewing?
With an afterhours high of 14.20, my guesstimate of 14.49 within the next several weeks might be on the conservative side. I would much rather be low and blow through the guess than be high and miss the estimate! The presentation was IMO one of the best that have been delivered to date. The confidence level of all the participants was very good, you could feel the excitement throughout the presentation. I believe the potential from this point forward of obtaining a partner in one or more trials has a reasonable shot. More and more, we are in the drivers seat, in that if we don't find a partner on our terms, we have the ability to complete the trials on our own. Perhaps we will close this week as one of the best so far. Would love to see the poor fellow who acquired the flesh eating disease placed on our filter, but if he is in hospice, it may be too late... Good luck to longs...
A very nice move in May, Bertha, along with solid consolidation, June and July... During this time we received news of acceptance into Russell 2000 and 3000, resulting in a base at 11 pps of 3.6 million shares, one heck of a base made up of institutional holders; expanding approvals in EU including Bilirubin and Myoglobin; plus, the expectation of break even just around the corner, perhaps this quarter? There is a lot going on here and all of it appears positive... For the chartists, I believe we see a cup and handle beginning June 15 thru today's close that looks to be completing the handle... I'm still looking for 14.49 pps within the next 5-6 weeks, especially with good news. I like it!
If we can hold 12.50 (I personally think we will close higher), it will be the first time in company's history that we gained a dollar in a single session. Quarterly 4 weeks away, influence from that, chart, Cramer and news suggests $14.49 within reason next 4 weeks... GL Longs!
If they did say that, and we know the new capacity is 4 times that of the original plant, then we can guesstimate that the original capacity would be $20 million or 20 to 30 thousand units annually.