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Impressed with the upcoming HemoDefend trial. "We plan to utilize the current manufacturing facility, leveraging existing assets and infrastructure, to produce HemoDefend clinical devices for the planned HemoDefend U.S. pivotal trial to start in late 2018-early 2019." If they are converting the present manufacturing facility to entirely producing HemoDefend for the trial, they are looking at easily 10's of thousands of bags for the study.
"More than 10,000 units of fresh frozen plasma are administered each day, or more than 3.6 million units per year, in the United States alone. With the exception of Type AB plasma, plasma typically requires blood-type matching with the patient to prevent incompatibilities and reduce the risk of major transfusion reactions. Because Type AB plasma lacks blood type-specific antibodies, it is called ‘universal plasma’ and can be readily administered to patients in emergency situations, making logistics fairly straightforward for both military and civilian applications."
hadtohavit, just curious, where did your cousin live?
Idunno, why would you sell now to a Fresenius for maybe $18 per share when CTSO will be worth many times that upon FDA approval and many, many more times that later?
Good luck on your $10 calls Orangecat, didn't you get a tremendous bargain on them?
I personally believe that with the small share count of 30 million, that there will be a 1-2 split when the share price approaches $30 or so. Certainly after FDA approval. My hope is that there will be several more after that.
DrNakamoto, coined yesterday seems curiously like a paulsby created alias, BorisBecker.
Dr. Harbord says the patient’s clinical improvement
was immediate and significant, with hemodynamic stabilization during the
first treatment, followed by enhanced liver function and mental status.
“We were able to demonstrate marked improvement in the patient’s
clinical illness by removing the cytokines, which were responsible for
his hypotension and shock,” Dr. Harbord says. “The dose of pressors,
the day-to-day bloodwork—all of it improved, and we saw a 56 percent
reduction in cytokines over the course of therapy.”
Dr. Harbord says that CytoSorb is nonspecific, removing many elevated
cytokines (both pro- and anti-inflammatory), but he adds that the risks
are not significant and that the risk of not intervening may be greater.
Given the results achieved in this investigational use, he says, cytokine
hemadsorption has potential as a treatment for HLH, a disease with a
mortality rate in excess of 50 percent.
“I think we demonstrated real proof-of-concept benefit for patients
through investigational use,” Dr. Harbord says. “I would not hesitate to
use it again, and I would hope it gives other nephrologists the confidence
to adopt it based on our experience at Mount Sinai.”
Let me help burnttoast out. It appears that EVERYTHING that you posted was incorrect. First of all, I doubt that you have purchased any shares, everything you post is negative, so you are apparently a short. Dr Chan will be here as long as he wants to be, like it or not. His $400,000 per year is not excessive for all of his roles. The stock price is near a 3 year high and will be much higher after earnings are released in another week or so. Attending investment conferences is not a waste of time, it brings in more investors. Recently we have seen big jumps in the share price after the conferences. True, they have retreated, probably due to shorts like you, but the trend is definitely higher. As far as signing the agreement with the success fee, that was probably all that they could do when they signed it. Banks are generally not lined up to loan money to development stage biotech firms.
wow! If that is correct, it would mean approximately $4 million in the quarter, just from Germany. If other sales areas jumped that much, that could mean that we broke even in Q1.
coldterdinvestor, I believe that today, and all of this week, you have seen the results of Dr. Chan attending investor conferences. We have matched our 52 week high, our 2 1/2 year high and will keep rising. The problem is that you keep looking back at the birthing CTSO, not at the present rapidly growing CTSO. Dr. Chan is out creating awareness of what this company can do and where it is going.
I would say that you are incorrect on every point that you have made. There probably are thousands of physicians that have adopted the beads,not dozens, there have been over 40,000 treatments so far and counting. I seriously doubt that Dr. Chan considers these meetings as vacations. A huge number are across the river from New Jersey HQ into New York. Again, share price has not been a straight line $7.50 for 8 years. Look at the chart and you will see 8 years ago as mostly, $4, $5 and $6, what you have posted is extremely deceptive. Also, it does not take perfect timing to make money in CTSO, you could have bought for under $4.00 easily 6 months ago. These opportunities come up often. You could have bought in at $7 on February 9th and be up 9% in a week.
Certainly there were some chasers, no doubt. However, they have had years to average down with shares in the $4's, $5's and $6's. Others have sold and move on. There is no way to tell, however, I am guessing that there would only be 10% with a cost basis of over $7.50 or .30 pre R/S.
That is fake news. I myself bought thousands of shares as low as .085 and .09 during that time, years ago. There have been recent opportunities to buy as low as $3.30 and to have doubled your investment within 6 months.
could the same person be buying the 1 share as who is selling? definitely a short or someone trying to drive the price down. it would only work during a slow time of the market day.
caesare, you posted about the upcoming inflection point, partnership with a large pharma company (cancer prevention). Was cancer prevention intentional? I hope so, could you please expand on that. Thanks in advance.
burnttoast247, you called this one exactly! I agree that there are several catalysts that can now make us go vertical. Cancer news, universal donor news, partnership news and several others will make us fly. Once again, I don't see any company out there with as much potential as this one, and with relatively low downside.
I seriously doubt that any corporation, anywhere, provides such a breakdown to it's shareholders. You just have to trust in management to make those decisions.
From Streetwise Reports Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA
Research Report
Source: Streetwise Reports (12/27/17)
Jason Kolbert, an analyst with Maxim Group, described the study, which enables this biotech's device to be used in patients undergoing heart surgery and will measure its effectiveness in reducing a common post-surgical side effect.
CytoSorbents
A Dec. 21 Maxim Group research report indicated the FDA has approved CytoSorbents Corp.'s (CTSO:OTCBB) investigational device exemption application (IDE) to conduct its REFRESH 2 trial. This milestone represents "a critical point for the company," noted analyst Jason Kolbert. "The trial by its nature (IDE) is 'pivotal,' designed to support the use of CytoSorb in cardiac surgery."
Kolbert explained that during surgery, CytoSorb can "capture and broadly reduce different kinds of cytokines and other inflammatory mediators that drive inflammation."
Now having a green light, REFRESH 2 in the United States should start soon, wrote Kolbert. Randomized, controlled and involving multiple centers, the trial aims to determine the effectiveness of CytoSorb blood treatment in reducing acute kidney injury following cardiac surgery, a common adverse side effect.
The study will encompass up to 400 patients who are slated to have "elective, nonemergent, open heart surgery for either valve replacement or aortic reconstruction with hypothermic cardiac arrest," Kolbert reported. All patients, control and treatment, will receive standard of care during surgery. Treatment patients, however, will also receive CytoSorb blood treatment intraoperatively.
Other potential endpoints to be investigated in REFRESH 2 include "time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators and mortality at 30 days," the analyst indicated.
Kolbert also recapped the findings from REFRESH 1, which evaluated the effectiveness of CytoSorb in treating inflammation in both cardiac surgery and critically ill patients. The study showed, with the use of CytoSorb, a statistically significant reduction, 26%, in plasma-free hemoglobin levels at three and a half hours. Levels were an additional 38% lower at four hours.
Maxim Group has a Buy rating and a $12 per share 12-month target price on CytoSorbents Corp., whose stock is currently trading at around $6.65 per share.
https://www.streetwisereports.com/article/2017/12/27/immunotherapy-firm-gets-green-light-for-pivotal-trial-from-fda.html?utm_source=delivra&utm_medium=email&utm_campaign=TLSR%2012-27-17&utm_id=34381559&dlv-ga-memberid=996291214
Read this yesterday. North Korean soldier who defected had anthrax immunity. It is thought that North Korea may be weaponizing anthrax and some other biological agents. Then I recalled this article about the US Army testing CytoSortents Cytokine filters for Biodefense, including anthrax. Anthrax can kill at least 80% of those exposed to it per the article.
https://nypost.com/2017/12/26/north-korea-soldier-who-defected-had-immunity-to-anthrax/
https://globalbiodefense.com/2015/12/22/army-testing-cytosorbents-cytokine-filters-for-biodefense/
There is this from Cytosorb regarding liver transplant, it may help.
Summary:
This case study reports on a 50-year-old immunocompetent woman who was admitted to hospital for acute hepatitis with acute liver failure. After transfer to ICU, the patient was diagnosed with hemophagocytic lymphohistiocytosis (HLH) due to herpes simplex virus infection with cytokine storm (IL-6: 81,059 pg/mL; Il-2: 6,815 U/mL; ferritin: 266,000 ug/L)) and rapidly developed MOF and was listed for highly urgent liver transplantation. Since existing liver support techniques (MARS treatment) for bridging to liver transplantation had no effect, SPAD (single pass albumin dialysis) in combination with CytoSorb® was applied, resulting in a marked decrease of IL-6, bilirubin as well as a reduction of vasopressor need. Orthotopic liver transplantation could be successfully performed on the 4th ICU day. CytoSorb® treatment was safe and well-tolerated, without any adverse events occurring. This is an example where CytoSorb® was used to help stabilize and bridge a critically-ill patient with acute, fulminant liver failure to liver transplantation with cytokine storm.
http://cytosorb-therapy.com/case-report/first-description-spad-combined-cytokine-adsorption-fulminant-liver-failure-hemophagocytic-syndrome-due-generalized-hsv-1-infection/
I wonder if the German Federal Ministry of Education and Research might underwrite a large scale sepsis trial in Germany?
Pearsby, it almost seems like you are posting to yourself, when you post to snow. The beads are growing at a very fast rate of 55% which is incredible. The large scale trials are coming very soon. The share price is what is discouraging but I expect it to double this year and then again for several years. Don't live in the past.
Dr. Chan has repeated many times that the company will be profitable during 2018.
paulsby, what you are posting is just not true, again. You and no one else knows why it is trading down. Good Sports explanation is much more likely, that is shorting. I would not be surprised that you are involved in that. And while it is true that it will be several years out for the trials to conclude, there will be many, many catalysts during that time. Sales are increasing at a tremendous rate, probably more PR's regarding cancer indications, possibly exciting news about Hemo Defend, military uses, etc.
No, we do not all agree that the rise from 6 to 7 was driven by "insider driven hike". That is ridiculous. We were and are undervalued to begin with. Then there were also stellar Q2 and Q3 earnings during that period along with news of introducing the ECMO Kit, the awarding of a phase 2 SBIR $1m grant to treat severe hyperkalemia, being recognized as being one of the fastest growing tech companies by Deloitte, an update on the start of the PACIFICA trial, using CytoSorb to treat severe acute pancreatitis, persistent rumors for future cancer applications,Aferetica and CytoSorbents Partnering to Enhance the Success of Solid Organ Transplantation. All of this and more has occurred during the rise from $5.40 to $7. It is a wonder that it hasn't been driven more higher.
From today's PR regarding the upcoming REMOVE trial " Interestingly, the REMOVE study will parallel our REFRESH 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval. The REFRESH 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery - but specifically excludes infective endocarditis - to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide." Some quick math shows that for each 100,000 procedures in which Cytosorb would be used would bring in $100 million in sales.
pearsby, the difference is that you have been caught 2 or 3 times by several members of the board. There are screen savers of you posting under different aliases, I have saved 2 of them myself.
That is impossible to track, either way. There are many dynamics occurring at once. On the other hand, his meetings could bear fruit weeks or months later. It is doubtful that someone leaves a meeting and invests in the company the same day. coldterinvestor they then do something called due diligence before they invest. Have you heard of that?
there is no doubt in my mind that pearsby and coltderinvestor are the same, along with several other aliases. pearsby also posts on the yahoo board with at least 6 aliases. You can tell when they post as a pack, also over time they use the same phrases. You can do that when you are retired I suppose.
colderdinvestor, do you truly believe what you post?
Biocon surges 14% on USFDA approval for biosimilar of cancer drug Herceptin.
http://www.business-standard.com/article/markets/biocon-surges-14-on-usfda-approval-for-biosimilar-of-cancer-drug-herceptin-117120400142_1.html
Pearsby, there are major partnerships. Fresenius, Terumo, Biocon and Dr. Reddy to name a few.
Pearsby, I am sure that your sub $6 prediction will be as wrong as your buying in at $5.45.
Just me but with the REFRESH 2 beginning, I think we would absolutely need a partner to pay for it. I do foresee rapid use in Europe, especially with Dr. June onboard, that is why he is here, he already knows that it works and is THE pioneer in the field.
techxen, thank you for your work on military grants. With everything viewable in one post, it is even more impressive. These grants should begin to pay off in orders soon. I am particularly excited about the universal donor. If it is adopted, I can foresee it perhaps being our largest source of income.
I am going with Dr. Chan's estimated 2020 FDA approval date, the company will do everything possible to complete this trial as soon as possible.
enough is enough! How are you going to pay for the large scale trials pearsby. Actually, sales are ramping up very nicely, Dr. Chan stated that the company will be profitable next year.
If you were truly being fair and balanced, have you considered that 13% increase in sales q over q is huge? 81% y over y is huge? The base amounts are increasing tremendously. Distribution areas are increasing, indications are increasing. To be fair and balanced, this company is poised to take off like a rocket ship. You will still be waiting to buy shares at $5.45.
pearsby, the q over q was 15%, not 10%. Any company, large or small would love that kind of phenomenal growth. And we are doing it quarter after quarter, after quarter, over not so anemic numbers.