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Yeah what is funny is I totally missed reading the entire article. If you click the small link and expand it and read it in entirety, it is Cytosorb and it says the following:
"The nephrology team earlier carried out blood filtration adsorption and cytosorb adsorption to treat inflammatory storms. At the busiest time, 6 CRRT slots are performed 24 hours a day. Up to now, blood filtration adsorption was involved in the treatment of a total of 7 patients, all treated patients increased IL-6 and other cytokines were decreased. Under the combination of other treatment measures, one of the patients successfully removed the trachea intubation, and the average course of the other 6 patients exceeded 3 weeks, prolonging the patient's life.
They didn't stop exploring. According to the literature reported that cytokine adsorption on the inflammatory factor adsorption effect is better, nephrology director Li Xuemei immediately contact overseas procurement and donation, complete the ethical application, from the United States adsorption column and Germany's supporting pipeline breakthrough difficulties came to concord ICU ward. From March 3, the "new weapon" has been used in clinical treatment, with the expectation of generating more benefits for early stage patients in severe illness."
Look at the pictures of the doctors all with 'thumbs up' and I swear that if you look closely at one of the pictures you can see the filter in the background of one of the photos. Those doctors and nurses look super excited to have a "new weapon".
Could be some good things coming next week.
Have a good weekend all!
Could this be Cytosorb?
Posted today on Sohu.com which is a popular Chinese online portal which mainly provides news, online games, sports, video, forum, blog and entertainment services (you will need a browser that translates from Chinese)
"Here is the Concord ICU of the China-French New City Hospital of Tongji Hospital in Wuhan, which is treating the most critical patients with neo-crown pneumonia. On the morning of March 5, 2 patients were still undergoing ECMO treatment, 16 received invasive mechanical ventilation, 3 received non-invasive ventilation and high-flow oxygen therapy, 3 received continuous renal replacement therapy (CRRT), and 2 received Bedside electronic bronchoscopy and suction under the microscope. There were 7 patients with hemodynamic instability and different degrees of shock."
https://www.sohu.com/a/377959531_102327
"....and the adsorption treatment of inflammatory factors was carried out earlier, which prolonged the patient's survival to a certain extent time."
KC sorry I missed your post but good to know I wasn't the only one that picked up on this. It seems now that the company's best prospects for getting the device used in applications here in the US are now for Breakthrough Device designation for the removal of platelet-inhibiting drugs (ticagrelor, others) or for Emergency Use Authorization for the coronavirus. This as Dr. Chan as the acting CMO is probably putting his sole focus on these areas, and REFRESH and Hemodefend are now long term efforts that the new CMO will probably be tasked with getting back on track once they hire someone.
Something brewing with AstraZeneca ?
I was in the airport coming back from a business trip and could not hear all of the analyst comments, but thought the interactions between Dr. Chan and the analyst from B. Riley were very interesting in regards to his questions regarding PhaseBio and their drug for removing Ticagrelor (Brilinta). After reading the transcript and doing a little research this morning I can see why the question came up from the analyst and the strange tight-lipped response from Dr. Chan.
PhaseBio got a $90 million investment from SF J Pharma for development expenses through the end of 2021 and up to an additional $30 million based on PhaseBio meeting specific, pre-defined clinical milestones for their ticagelor removing drug PB2452.
https://www.benzinga.com/general/biotech/20/01/15105863/phasebio-rallies-on-funding-agreement-for-early-stage-anticoagulant-reversal-agent
So basically we have a potential competitor in the removal of Ticagrelor. However here is where it gets interesting in the comments.
Dr. Chan stated that "with Ticagrelor going off patent, it's believed by 2024, the cost differential between Ticagrelor and clopidogrel should also decrease significantly. Because of that the ability to be used with Ticagrelor is a major advantage for us."
…. Translation: More Ticagrelor use -> more Cytosorb use
Dr. Chan then states "it's a biologic that is that - well, I think, at the end of the day, is not very cost competitive with our product, given that it is a biologic and that it will expire on the shelf, and will have to be repurchase at high cost by the hospital. And so we'll see how the dynamics work out." and "for cardiac surgery, we believe that our product which is easily installed into the cardiopulmonary bypass machine, and has a relatively reasonable and cost effective cost, as we've demonstrated in a study that came out last year, showing that even taking into consideration the cost of the device that use of the device per patient would save hospitals a projected $5,000. We believe that CytoSorb would actually be a very easy therapy to be able to use for this application in cardiac surgery patients. And so we'll see how that turns out"
The analyst then remarks: "AstraZeneca for example, while PhaseBio is still in clinical trial, …..has a small window left to be able to recapitalize before generics start coming into the market. Just from where I'm standing, make a lot of sense for them to work with you to help with their adoption."
Dr. Chan's response: "Well, I think that the goal of a lot of pharmaceutical manufacturers is to maximize the revenue opportunity further for their drugs, particularly ones that are very key to their pipeline. And so the ability to dominate a market or the potential to dominate a market should be very attractive and to be able to eliminate competitors from that market. So that's all I can say at this time. "
So in summary you have a compelling case of one of the largest pharma companies AstraZeneca with a drug that is generating for them over $1B annually with a 2-3 window left for sales before generics start whittling that down. In order to maximize sales they need to offset those risks from bleeding events and extra costs when used during cardiac surgery. So partnering with CTSO makes sense in this light. And in light of the $120M in funding that PhaseBio received you can see how big a deal this is and why Dr. Chan seems to think this is also the company's ticket finally into the U.S.
Thoughts?
Agree hemo, once they publish some individual cases there will be hospitals from the different countries where the filter is approved and registered, calling their distributors to start placing orders.
This is a gift to those distributors in countries were the filter is already registered who have done nothing in terms of sales.
If this gets worse over the next few months, then that study in China when it is published will be a watershed event that for sure will trigger sales in other countries.
There is also a spill over effect from all this in that hospitals will probably want to keep a stock of the filters on hand for future pandemics like this.
Wake up call distributors!
Probably a 7 out of 10 for me - if it wasn't for the coronavirus prospects which have just come on the scene this would have been a 5 out of 10 for me. I was very disappointed at the Hemodefend update where the IDE is now expected to be submitted / approved by Q4 2020, with the trial to start soon after. So you are looking at mid-2021 in what could have been a mid-2020 FDA approval for Hemodefend which was the company's best shot at getting something approved here in the US. It wasn't too surprising that they want to out-license Hemodefend to a partner but before they can even attract one they need to get this IDE approved and the trial underway with a data readout. The REFRESH II update was also another disappointment where they are hoping to restart the trial this summer and even if they do it would be a miracle for them to complete the enrollment by the end of 2021 so you are looking at 2022 for this potential approval. So the two biggest strategic efforts the company had underway for a pathway to FDA approval are continuing to struggle. It doesn't help not having a CMO in place, which by the way they said is still a few months away, even though they have a few potential candidates. So I assume Dr. Chan is still operating in both CEO and CMO roles.
The silver lining in the call is that the company is getting a lot more exposure from this coronavirus epidemic and has some potential opportunities should they get some contracts with the US government task force and from China Medical Systems and seems to be getting some return on investment direct sales force expansion.
REMOVE actual recruitment ended up being 288 patients or 38 more than the target enrollment of 250. The company has stated that the data readout from this trial is still on track for mid-year. If the top-line results are positive and statistically significant, there could be an impact on the share price, but this will have no impact on the price this week. Other factors potentially could however, updates on FDA and BARDA discussions, coronavirus patient treatments, or most impactful guidance regarding Q1.
Official study registered today in Chinese Clinical Trial Registry
Found this posted today on the Chinese equivalent of the clinicaltrials.gov site. This study will be needed to publish the rationale for using Cytosorb to treat COVID-19 and as a prerequisite to possibility for future commercial collaboration in China with China Medical Systems. It was approved by the Ethics Committee on 2020-02-28 in Beijing. China Medical Systems is funding it. It's a single arm study with 28 day mortality as the primary outcome with a study size of 19 patients. For additional details see below and the link to the study. Let me know if the link does not work for you.
Cytosorb Adsorption Therapy Combined with Standard Therapy for New Coronary Virus Pneumonia (COVID-19) in Adult Severe Patients
Registration Number: ChiCTR2000030475
Last updated:
Date of Last Refreshed on: 2020-03-03
Date of Registration: 2020-03-03
Registration number status:Pre-registration
Registration title: Cytosorb Adsorption Therapy Combined with Standard Therapy for New Coronary Virus Pneumonia (COVID-19) in Adult Severe Patients
Public title: Cytosorb in Treating Critically Ill Hospitalized Adult Patients with novel coronavirus pneumonia (COVID-19)
Official scientific name of the research topic: An open study to evaluate the efficacy and safety of Cytosorb adsorption combined with standard therapy in the treatment of critically ill patients with new type of coronavirus pneumonia (COVID-19)
Scientific title: The Effect and Safety of cytokine removal therapy in Treating Critically Ill Hospitalized Adult Patients with novel coronavirus pneumonia (COVID-19) adult patients: a Prospective Open-label Study
Primary sponsor: Department of Nephrology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
More details can be found at: https://translate.google.com/translate?hl=en&sl=zh-CN&u=http://www.chictr.org.cn/showproj.aspx%3Fproj%3D50452&prev=search
(translated from Chinese)
Excellent news today! If this study which was published today is indicative of the REMOVE trial results in Germany, which should be released around mid-year, this could bode well for the company's prospects here in the US for this indication. Positive results from REMOVE would have important implications in the U.S. where infective endocarditis is rampant due to the opiate crisis and use of dirty needles. It's possible that once armed with positive REMOVE data, CTSO could apply for Breakthrough Device Designation (replaced the previous Expedited Access Pathway or EAP designation) for the infective endocarditis indication allowing CTSO to pursue additional supporting clinical data in the US after its approval for use.
https://www.prnewswire.com/news-releases/cytosorbents-highlights-recent-publication-using-cytosorb-during-cardiac-surgery-for-infective-endocarditits-301014190.html
Bertha will be sorely missed by a lot of people on this board including myself. I will always remember him for his upbeat outlook for this company. He never wavered in his belief that this product would one day become the standard of care in hospitals all over the world. Thanks for letting us know Andy.
FDA Emergency Use Authorization for in vitro diagnostics
Saturday morning the FDA released sweeping new guidelines speeding up hospitals' ability to test for the virus. Now we just need this for the treatment of the critically ill.
https://www.fda.gov/media/135010/download
Virus has now come to NJ
While much of the focus so far has been on the West coast, local media outlets reported on Saturday that a suspected coronavirus patient has been isolated at Bayshore Medical Center in Holmdel, New Jersey, as the hospital awaits the results of a test, which could take a few days: https://bit.ly/2vvhyOn
If I am not mistaken, Bayshore Medical I thought was one of the recruiting hospitals in a previous clinical trial, but I went back to REFRESH and others and could not find it. In any event, this is right in the company's backyard in NJ (only 30+ minutes away)
https://bit.ly/3ahz7Ak
Additional insights regarding Dr. Chan's BARDA comments
CG @YMB "From Chan's Bloomberg Radio Interview: He stated CTSO has been in discussions with BARDA = Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services established in 2006 in order "to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza (PI) and emerging infectious diseases (EID)." If discussions go well, BARDA could be a strong advocate with the FDA to push for approval in a potentially expedited manner (e.g., Breakthrough Device Designation). Hopefully, we'll hear more about CTSO's conversations with BARDA next week. BARDA's home page: https://www.phe.gov/about/barda/Pages/default.aspx"
Italian health authorities just confirmed three more deaths in Lombardy, bringing the national death toll to 21, while the number of confirmed cases rises by nearly 200 to 821. Italy now has the third-largest death toll, behind only Iran and mainland China. Aferetica is the company's distributor in Italy and is top notched. I would expect they have already been in contact with hospitals in Lombardy and other regions
https://www.aferetica.com/en/possible-use-of-cytosorb-in-patients-affected-by-covid-19/
You are welcome. Just trying to pour a little gas on the fire before the weekend :) I think next week could be one of the more important and pivotal weeks for the company in recent history.
ECMO-TEAM (Technology of Extracorporeal Assist Meeting) at the University Hospital of Zurich in Switzerland today
CG reminded everyone that today, the company is sponsoring a hands-on workshop (along with Fresenius and Terumo) at the ECMO-TEAM (Technology of Extracorporeal Assist Meeting) at the University Hospital of Zurich in Switzerland today (2/28) and tomorrow (2/29): Fortunately, the size is capped at 250, so it's under the 1000 threshold for public gathering bans that Switzerland just imposed through March 15th. Here are the first two 30-minute workshops in "Hands-on Workshops Module A": (1) Corona Virus Update; and (2) Cytosorb on ECMO. As you may recall, ECMO is one of the techniques to help CV patients when their lungs fail or become compromised because of the resulting pneumonia or acute respiratory distress syndrome (ARDS).
It will be interesting to see what information they have concerning the virus update.
https://cytosorb-therapy.com/wp-content/uploads/2020/02/070220-technology-of-extracorporeal-assist-meeting-ecmo-team-programm.pdf
Needless to say the company is moving to get all things in place to begin treatments. I would venture to say that there could be a report of a first treatment as early as at the Cowen Healthcare conference on Monday, or during the earnings call next Thursday.
Top Coronavirus Stocks backed by Scientific Evidence
Cytosorbents under "3. Stopping Lung Damage"
https://insiderfinancial.com/top-coronavirus-stocks-backed-by-scientific-evidence/179657/
We have two shots on goal next week with the Cowen Healthcare conference on Monday and earnings on Thursday. My guess is that a lot more information will be forthcoming next week, not just as it relates to the coronavirus but also updates on a lot of other fronts (e.g. Hemodefend, REFRESH II, REMOVE, direct sales in Germany, etc.). Let's hope that the hysteria out there in the market will subside and we will have an environment in which some news on these fronts will have more of an impact on the stock price.
2nd published case report of CAR-T CRS treatment
I believe this is the second case published. The first was in the press release dated February 5 and was published in the journal, Critical Care Explorations, a publication of the Society of Critical Care Medicine, of a 14-year old boy with refractory acute lymphoblastic leukemia. I ran across this one today in the Journal of Critical Care which was dated February 19, 2020. It was of a 65?years old male who developed grade 4 CRS with refractory shock after CAR-T application.
https://www.sciencedirect.com/science/article/abs/pii/S0883944119318313
What was interesting is at the end of the article they said that the Extracorporeal Cytokine Adsorption as Additive Treatment of CAR-T Associated Cytokine Release Syndrome (CRS) (CYTORELEASE)trial which is being run out of Hannover in Germany is recruiting, yet on the ClinicalTrials web site it shows they have not started recruiting yet - maybe the web site has not yet been updated to reflect this.
Extracorporeal cytokine removal in severe CAR-T cell associated cytokine release syndrome
Abstract
Purpose
Life-threatening complications of CD-19 Chimeric antigen receptor - T (CAR-T) cells such as the cytokine release syndrome (CRS)) have been reported. Treatment is limited to IL-6 blockade and steroids although global removal of elevated soluble inflammatory factors might be more effective.
Methods
Clinical course of a CRS patient treated with extracorporeal cytokine adsorption (Cytosorb®). A panel of 48 cytokines, chemokines and endothelial markers has been analyzed longitudinally. Ex vivo stimulation of endothelial cells to visualize (immunocytochemistry) and quantify (ECIS, TER) endothelial barrier effects.
Results
Following CAR-T cell application a 65?years old male developed grade 4 CRS with refractory shock (3 vasopressors) and severe capillary leakage (+37?L/24?h resuscitation). Treatment included IL-6 blockade, methylprednisolone and additionally Cytosorb hemoperfusion. While multiple soluble inflammatory factors were elevated and most of them decreased by more than 50% following Cytosorb, markers of endothelial injury increased steadily (e.g. Angpt-2/Angpt-1) leading to profound endothelial activation and leakage in ex vivo assays.
Conclusion
This is the first reported use of cytokine adsorption for CRS showing efficacy in absorption of various cytokines but not endothelial growth factors. A randomized controlled trial to evaluate additional Cytosorb treatment in CRS is currently recruiting at our institution (NCT04048434).
https://clinicaltrials.gov/ct2/show/NCT04048434
It's unbelievable what the expectations are around this coronavirus. People need to realize that it was only 6 days ago they announced this arrangement with CMS. Give them time to get the filters, documentation and other supporting components shipped and the people and personnel in place to train them on how to perform these first few cases. Also in order to properly record all of the data they need to report on so that the rest of the world can see what impact the filter has. Remember they haven't treated a patient with COVID-19 yet so getting this right the first time is extremely important for the future of the CMS relationship and expedited pathway in China. Oh, and by the way if you are one of the impatient ones, feel free to volunteer to transport the devices over there and plug them in yourself.
CytoSorbents Enters Agreement with China Medical System Holdings Limited to Bring CytoSorb to Mainland China to Treat Critically-ill Patients with COVID-19 Coronavirus Infection
"CytoSorbents will donate initial CytoSorb devices and provide product, training, and support to CMS to introduce CytoSorb initially into four hospitals in the Wuhan, China area. The therapy will be evaluated in severe COVID-19 coronavirus patients with a systemic inflammatory response who are being treated with either continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO). During the initial term of the agreement, CytoSorbents and CMS will explore the possibility for future commercial collaboration in China. "
I found this post on a U.S. Chinese message board this morning. This individual I don't believe is a medical professional, yet he seems to have a good knowledge of the virus and what was interesting was he was aware of Cytosorb. It's long but worth the read.
"I've been up studying COVID-19 for the past few weeks for a substantial portion of every day, and I've come to a few very disturbing conclusions about the virus.
It may have the potential to cause antibody-dependent enhancement of disease, like Dengue flavivirus. SARS had the same capability, and due to the genetic similarities between SARS-CoV and SARS-CoV-2, ADE can't be ruled out.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3019510/
Taken together, our data suggested that SARS-CoV is able to enter human immune cells via an antibody-mediated pathway and immunological consequences of such infection are under investigation (productive replication, cytokines secretion profile and cell death etc). Our data raise reasonable concerns regarding the use of SARS-CoV vaccine in humans and pave the way to further studies focusing on the role of immune-mediated infection phenomenon during SARS pathogenesis.
https://jvi.asm.org/content/jvi/early/2019/12/05/JVI.02015-19.full.pdf
Our results showed 37 that mAb binds to the virus -surface spike, allowing it to undergo conformational changes 38 and become prone to proteolytic activation. Meanwhile, mAb binds to cell-surface IgG 39 Fc receptor, guiding viral entry through canonical viral-receptor-dependent pathways. 40 Our data suggest that the antibody/Fc-receptor complex functionally mimics viral 41 receptor in mediating viral entry. Moreover, we characterized mAb dosages in viral42 receptor-dependent, antibody-dependent, and both-receptors-dependent entry pathways, 43 delineating guidelines on mAb usages in treating viral infections. Our study reveals a 44 novel molecular mechanism for antibody-enhanced viral entry and can guide future 45 vaccination and antiviral strategies.
I keep hearing rumors about individuals "relapsing" with the disease and getting sicker and sicker with pneumonia before expiring. It may be a clue that the virus is actually hijacking immune cells by using weak or improper antibody response to hitch a ride into immune cells. Normally, with Dengue, that only happens if someone gets infected with a different strain. With COVID-19, it may be the case that it's doing this with the same strain, causing people to become reinfected and severely ill as a consequence. I confess that I don't understand how that could be possible, or what the exact mechanism behind this could be. It may be that I'm misreading this and misunderstanding the science behind it. I keep hearing reports of people having "weak antibodies" and not becoming properly immune, and if ADE is actually the culprit here, the consequences could be severe.
https://www.usatoday.com/story/news/nation/2020/02/19/coronavirus-after-2000-deaths-can-you-get-virus-again/4804905002/
This would be terrible news if true, because it would mean that herd immunity would be difficult to develop, allowing the virus to be transmitted with impunity. It would also mean that China's plan to ease quarantine restrictions and send people back to work before their economy collapses would be doomed from the outset. People would start getting sick again almost immediately. It would be a disaster. It already is a disaster.
I hear that Chinese doctors are using serum antibodies from recovered patients to cure critically sick people, with considerable success. This is another clue. Some people may possess the right characteristics to produce potent antibodies that are effective against the virus, while others may not. However, these phenomena have not been fully investigated or confirmed with SARS-CoV-2, yet, so all of this is just my own speculation coupled with what we already know about SARS-CoV. It would have to be studied experimentally.
It may also be causing immune sensitization and cytokine storms, leading to a great deal of tissue damage. Some case studies of patients seem to indicate a highly overactive cytokine response that caused excess inflammation and basically obliterated a patient's alveoli.
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30076-X/fulltext
Peripheral blood was prepared for flow cytometric analysis. We found that the counts of peripheral CD4 and CD8 T cells were substantially reduced, while their status was hyperactivated, as evidenced by the high proportions of HLA-DR (CD4 3·47%) and CD38 (CD8 39·4%) double-positive fractions (appendix p 3). Moreover, there was an increased concentration of highly proinflammatory CCR4+CCR6+ Th17 in CD4 T cells (appendix p 3). Additionally, CD8 T cells were found to harbour high concentrations of cytotoxic granules, in which 31·6% cells were perforin positive, 64·2% cells were granulysin positive, and 30·5% cells were granulysin and perforin double-positive (appendix p 3). Our results imply that overactivation of T cells, manifested by increase of Th17 and high cytotoxicity of CD8 T cells, accounts for, in part, the severe immune injury in this patient.
Lastly, and most disturbingly, the way the virus binds to ACE2 receptors may allow it to severely dysregulate the angiotensin-renin system of the body, potentially causing cardiopulmonary damage by directly affecting blood pressure. This is another thing that SARS-CoV does, which SARS-CoV-2 is most likely doing as well, given that it also binds to ACE2 receptors with a high degree of affinity in order to enter cells.
https://www.futuremedicine.com/doi/10.2217/fvl.10.4
Viruses critically depend on host cell-encoded proteins and corresponding mechanisms to ensure their survival and replicative success. As a consequence, many host cell proteins are important contributors to the complex process of viral pathogenesis [15]. Cell surface components that are exploited as primary receptors to mediate viral entry represent the most obvious host cell proteins involved in establishment of a viral infection. Following target cell entry, several viruses are known to induce downmodulation of receptor expression. As a result, natural physiologic functions of these host cell components may be seriously impaired, with accompanying pathogenic consequences for infected cells, organ or individual. Paradoxically, viruses strongly benefit from downregulation of receptor expression [16], since it leads to controlled and productive infectious processes. Receptor downmodulation prevents infection of cells in which viral replication is already progressing [17], and is often needed to ensure efficient release of viral particles [18]. A number of viruses are known to induce cellular receptor modulation, including HIV, measles virus, influenza C virus and human herpes virus type 6 [19–22], as well as CoVs. Two integral proteases of the renin–angiotensin system (RAS), a major physiologic regulator of the cardiovascular system, facilitate cellular entry of several HCoVs: angiotensin-converting enzyme (ACE)2 and neutral aminopeptidase (aminopeptidase N [APN]) [23–26]. Here, we will discuss the interaction of SARS-CoV, HCoV-NL63 and HCoV-229E with renin–angiotensin proteases during their cellular entry, and the pathogenic consequences of HCoV-induced RAS dysregulation by receptor downmodulation at the primary site of infection.
There are other papers emerging that seem to confirm this also applies to COVID-19:
https://www.ncbi.nlm.nih.gov/pubmed/32061198
The novel coronavirus 2019 (COVID-19) infected patients by binding human ACE2, leading to severe pneumonia and highly mortality rate in patients. At present, there is no definite and effective treatment for COVID-19. ACE2 plays an important role in the RAS, and the imbalance between ACE/Ang II/AT1R pathway and ACE2/Ang (1-7)/Mas receptor pathway in the RAS system will lead to multi-system inflammation.
Many SARS vaccines have been tested over the past 17 years, but most of them were failures. They provoked T-helper immunopathology, excess cytokine release, and organ damage. They sensitized the lab animals' immune systems, causing an over-exuberant immune response that damaged lung tissues.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0035421
An early concern for application of a SARS-CoV vaccine was the experience with other coronavirus infections which induced enhanced disease and immunopathology in animals when challenged with infectious virus [31], a concern reinforced by the report that animals given an alum adjuvanted SARS vaccine and subsequently challenged with SARS-CoV exhibited an immunopathologic lung reaction reminiscent of that described for respiratory syncytial virus (RSV) in infants and in animal models given RSV vaccine and challenged naturally (infants) or artificially (animals) with RSV [32], [33]. We and others described a similar immunopathologic reaction in mice vaccinated with a SARS-CoV vaccine and subsequently challenged with SARS-CoV [18], [20], [21], [28]. It has been proposed that the nucleocapsid protein of SARS-CoV is the antigen to which the immunopathologic reaction is directed [18], [21]. Thus, concern for proceeding to humans with candidate SARS-CoV vaccines emerged from these various observations.
My fear is that they may attempt to fast-track a vaccine, only to find that it fails in trials over and over again due to cytokine sensitization and/or ADE, leading to poor clinical outcomes and forcing them to go back to the drawing board.
If that were to happen, and if sustained outbreaks were to occur in various places across the globe with no vaccine to counter them, the loss of life would be unbelievable.
Without a vaccine, what do we have to fight this? Well, this is what I'm looking at right now:
Remdesivir & Chloroquine. Inhibit RNA replication of the virus. Remdesivir seems to have potent activity against SARS-CoV-2 replication, but this has not been experimentally confirmed with good sample sizes and controls.
CytoSorb. An adsorbent material consisting of special polymer pellets with tiny pores to trap excess cytokines. Filters blood extracorporeally.
Losartan and Telmisartan. Angiotensin blockers to try and keep the virus away from ACE2 receptors.
Vasodilators & Vasopressors to help regulate blood pressure in case of ACE2 dysregulation.
There isn’t enough. There isn’t enough of any of this medication to deal with the number of infected we would have in a pandemic scenario. CytoSorb and similar extracorporeal blood therapies are extremely rare boutique therapies that are only available to a number of critically ill patients numbering in the hundreds worldwide.
I am so afraid right now, you have no idea. I am experiencing unmanageable levels of distress from having delved into this. I only hope that this compiled information is useful to someone. "
I saw this as well and downloaded the published study from SCRIBD
https://www.scribd.com/document/448385523/s-2213260020300795#download
This is very significant in that it is the first published study of the mortality of patients with SARS-CoV-2 pneumonia in Wuhan, China. Now the world gets to see the REAL numbers.
Since the Wuhan coronavirus first appeared late last year, researchers have been studying it, though for the first month or so, only Chinese scientists had access to the data. But now that China has shared its data with the world, research has been appearing more quickly, with more opportunities for peer review. According to a study published in the Lancet on Friday, patients who are especially vulnerable to severe COVID-19 infections - a group that includes the very old, very young and those with co-occurring conditions - die at a higher rate from COVID-19 than they did from SARS and MERS.
A study of 52 critically ill adults at Wuhan Jin Yin-tan hospital found that 61.5% of patients requiring hospitalization and intense monitoring ended up becoming "non-survivors", to borrow some of the researchers' terminology. The researchers concluded that COVID-19 - or SARS-CoV-2, as they call it - is more lethal for vulnerable patients than SARS or MERS was.
The study was based on 710 patients who were diagnosed with COVID-19 and out of these 201 ended up with pneumonia and out of these 52 were admitted to the ICU in critical condition (these are the patients that Cytosorb is targeting) - so almost 8% of those getting the virus end up in the ICU. Of these 32 (61·5%) patients had died at 28 days, and the median duration from ICU admission to death was 7 days !!!
This is much higher than people originally thought. Most patients had organ function damage, including 35 (67%) with ARDS, 15 (29%) with acute kidney injury, 12 (23%) with cardiac injury, 15 (29%) with liver dysfunction, and one (2%) with pneumothorax (table 2). Hospital-acquired infection was noted in seven (13·5%) patients, including one (2%) patient who had pulmonary and blood stream infection of carbapenem-resistant Klebsiella pneumoniae. Cytosorbents has published case studies for patients having all of these conditions and were successfully treated.
Raptor, something that was being discussed on the YMB, was the current production capacity of $80M+/-.
Someone pointed out that "at around 7000 filters/month, supporting $7M revenue, this is the proposed upper limit of production. But there is still the "old" production facility which is used to produce Hemodefend and all other product lines. Could be switched to the CytoSorb standard filter easily - could contribute additional capacity. Would not be surprised to see a PR concerning production ramp-up measure in near future."
If there were to be some positive cases demonstrating the effectiveness of the filter, whether in China or elsewhere, there could be a huge demand that would be difficult to plan for. Combine this with any demonstrable increases in direct sales due to the increased headcount in Europe, and the potential that Fresenius could place some large initial orders for Mexico and South Korea if the product registration goes through this year, and you have a production forecast that would be difficult to manage to.
Interesting to see how quickly things could turn on all fronts.
I am really hoping for some more good news and momentum going into this next earnings call for I see it to be one of the most important calls the company has had in a long while.
Ex vivo lung perfusion
Cytosorbents partnered with their distributor Aferetica in Italy back in 2017 to develop their Perlife system which is used for ex-vivo organ perfusion using Cytosorb's adsorption technologies to cleanse and recondition harvested solid organs such as the kidneys, livers and other internal organs: https://www.aferetica.com/en/therapeutical-solutions/perlife-tm/
Aferetica also developed PerLungs which is used for ex vivo reconditioning of donor lungs prior to transplantation : https://www.aferetica.com/en/therapeutical-solutions/perlungs/
In this month's Journal of Thoracic and Cardiovascular Surgery they published a study of ex vivo lung perfusion (EVLP) using Cytosorb, applied to donor lungs outside of the body before transplantation that improves organ quality and makes lungs that were previously unsuitable safe for transplant.
https://www.sciencedirect.com/science/article/abs/pii/S0022522320304724
This study doesn't mention specifically the Aferetica kit but nonetheless its good to see that the device is getting more published studies about the device use in this area. Lung transplantation is the only life–saving therapy for patients with certain types of end–stage lung disease; however the procedure has limited availability because not all donor lungs are safe for transplantation. This shortage of donor lungs results in the death of 20 percent of lung transplant candidates awaiting transplant.
Less than two weeks until the next earnings report
Things I am expecting to hear:
• Investments in direct sales force - they added 50 new headcount to their sales team in the past 6 months in their direct sales territories, mainly Germany. Are they seeing significant results from this investment. From the last call they project that each salesperson will average $2-3m in sales per year. Remember, they are selling over $1m a year to just one hospital in Germany and this was before they made these investments.
• REFRESH 2 trial here in the U.S. (cardiac surgery) - what's the plan for resuming the trial and the execution plan for it, assuming all of the data analysis was completed for the DMC.
• REMOVE trial in Germany (infective endocarditis) - Outcomes for the study are expected to be reported in mid-2020, but are they able to say whether the top-line results achieve their primary endpoint. The results from this trial will be another large driver of sales in Germany in addition to the label expansions received for bilirubin and Ticagrelor removal
• Updates on product registration in Mexico and South Korea - if the product registrations go through this year, expect Fresenius to place large initial stocking orders for these countries as they were not legally able to transfer their European inventory to these countries.
I don't list an update on Hemodefend IDE filing with the FDA because I am holding out hope that the company doesn't want to go another conference call with more reasons why this IDE has not been filed. I am holding out hope that we will hear news of this next week.
Any news next week of coronavirus patients from China who have been successfully stabilized using the filter, will also provide a significant boost to the share price going into the earnings call.
Things finally seem to be turning in the company's favor.
Posted today in NS Medical Devices
US firm CytoSorbents says its blood purification filter could cure critically-ill coronavirus patients
By Dan Robinson 20 Feb 2020
https://www.nsmedicaldevices.com/news/cytosorbents-coronavirus/
How CytoSorbents will help treat coronavirus
Working alongside Hong Kong-based China Medical System Holdings Limited (CMS), it will then seek to commercialise the treatment should the duo succeed in obtaining regulatory clearance under a fast-track review process introduced in response to the outbreak of the 2019 novel coronavirus – which is code-named Covid-19 and carries flu-like symptoms.
CytoSorbents will also provide product training and support for its blood purification technology, which has been used in more than 80,000 global treatments.
It will be used alongside both continuous renal replacement therapy – which replaces the normal blood-filtering function of the kidneys – and the respiratory support technique known as extracorporeal membrane oxygenation for severely ill patients.
CytoSorbents vice-president of business development Chris Cramer said: “We are excited to collaborate with CMS to bring CytoSorb to the patients and physicians in China that are dealing with this devastating Covid-19 coronavirus pandemic.
“To date, this infection has killed approximately two to three out of every 100 patients it infects, mainly by causing severe lung injury in acute respiratory distress syndrome (ARDS), shock and multi-organ failure.
“Though CytoSorb has not yet been used to specifically treat patients infected with the Covid-19 coronavirus, it has been used to help treat shock, ARDS, multi-organ failure, and other complications of cytokine storm and excessive, deadly inflammation in thousands of patients with both bacterial and viral infection – and sepsis – across the world.”
Why CytoSorbents believes its treatment will help severely ill coronavirus patients
A study by Chaolin Huang et al in medical journal The Lancet found that the most seriously ill coronavirus patients admitted to intensive care units showed significantly higher levels of inflammatory cytokines compared to those who weren’t admitted.
Known as a cytokine storm, this syndrome describes an overproduction of immune cells and their activating compounds, or cytokines, which can both sicken and kill patients infected with certain strains of flu virus.
Like in previous pandemics including SARS and MERS, cytokine storm can trigger a viral sepsis in coronavirus infection, leading to pneumonia, ARDS, shock, multi-organ failure, respiratory failure and potentially death.
Other recent studies have shown how extracorporeal blood purification therapy can be effective in coronavirus.
The technique involves passing blood through a device – such as a sorbent, a material that absorbs or adsorbs liquids or gases – to remove toxins or waste products, primarily for renal failure patients.
CytoSorbents, which trades on the Nasdaq Stock Market in New York City, says this provides the rationale to potentially use CytoSorb, the first specifically-approved extracorporeal cytokine adsorber in the European Union, in this setting.
The filter is attached to a hospital’s existing blood-pumping equipment and uses a cylindrical cartridge of tiny polymer beads to remove toxins from a patient’s circulatory system – thus helping reduce inflammation.
This can alleviate the cytokine storm and avoid its life-threatening complications, as well as help with stabilising circulation and increasing the chance of recovery.
It has been sold in 58 countries worldwide and used in more than 800 clinical departments.
Role of China Medical System Holdings in bringing CytoSorb to China
CMS, which trades on the Hong Kong Stock Exchange, claims to be a “well-established, innovation-driven specialty pharma with a focus on sales and marketing in China and Asia”. It recorded a turnover of 5.43bn Chinese yuan ($773m) in 2018.
With a focus on research and development of innovative drugs, it aims to find products and services for China’s “unmet medical needs”.
General manager of global investment and operations Dr Huaizheng Peng said: “CMS looks forward to working with CytoSorbents to bring its innovative CytoSorb blood purification therapy to the forefront of the response to the Covid-19 pandemic.
“We do so with a sense of social responsibility to help those stricken at the epicentre of the outbreak, just one of the many areas in China that we serve.
“We believe that CytoSorb may provide physicians with a powerful new approach to help patients who are suffering from severe coronavirus infection.”
The product would have had to been sold to the hospital through the company's distributor Chong Lap (H.K.) Co. Ltd., however Cytosorbents or Cytosorb is not listed anywhere on their web site.
https://www.chonglap.com/company/company-profile
Chong Lap (H.K.) Co. Ltd. was brought on as a distributor in 2018, and from what I have read, medical device registration in Hong Kong is not an extraordinarily long process as some of the other countries are (e.g. Russia). Here are the steps they would have had to go through:
Hong Kong Approval Process for Medical Devices
Medical devices in Hong Kong are regulated by the Medical Device Control Office (MDCO).Though the decision to register devices in Hong Kong is voluntary, both private and government hospitals generally prefer the MDCO listing number to show that the device is approved. Manufacturers who intend to sell to hospitals are encouraged to register..
Typically the classification of your device matches classification in the European Union (EU). See how long it takes (on average) to obtain device approval in Hong Kong. Download the chart using the short form below. The Medical Device Control Office (MDCO) medical device approval process explained...
Registration of medical devices in Hong Kong is overseen by the Medical Device Control Office (MDCO). The process is currently voluntary,* but is intended as a phase-in of mandatory registration. The MDCO has set up the Medical Device Administrative Control System (MDACS) to facilitate the transition.**
Classify your device or IVD according to Classification Rules for Medical Devices. Typically the classification of your device matches classification in the European Union (EU). Foreign manufacturers will be able to leverage their prior authorizations in Australia, Canada, the EU, Japan, or the USA. Class I devices have no registration process and cannot be registered (even voluntarily). You may import Class I devices immediately. All instructions below will reference the process for Classes II, III and IV devices.
Step 1- Appoint a local company to act as your Local Responsible Person (LRP). The LRP will be responsible for coordinating your application and submission, as well as post-market vigilance activities.
Step 2- Obtain proof of marketing authorization from from Australia, Canada, Europe, Japan or the USA. Most companies supply a copy of their CE certificate or US FDA 510(k) letter as proof of compliance.
Step 3- Prepare MDACS application (Form MD-C2&3&4 for medical devices; Form MD-IVD for IVDs). Required documents include: CE Certificate or 510(k) letter, proof of Quality Management System compliance (e.g., ISO 13485 certificate), labelling*** and Instructions for Use (IFU),**** post-market procedures, international test reports and clinical data (if applicable), and Essential Principles Checklist (and a Performance Evaluation Report for IVDs). Documents should be provided in English or Chinese, or must be accompanied by an English or Chinese translation..
Step 4- Appoint an authorized importer located in Hong Kong.
Step 5- Your LRP submits the application to the MDCO.
Step 6- MDCO reviews application and may request additional documentation or clarification. LRP must provide any responses to MDCO inquiries in a timely manner.
Step 7- Upon approval, device is assigned a Hong Kong Medical Device number, and listed in MDCO database. Approval is valid for 5 years. LRP must submit application for continuation of the listing to the MDCO at least 3 months prior to expiration.
Step 8- You may now begin marketing your device in Hong Kong.
* Though the decision to register devices in Hong Kong is voluntary, registered devices are given preference in public tenders. Manufacturers who intend to sell to hospitals are encouraged to register.
** The voluntary registration process is intended to alleviate some of the expected rush of applications when the process becomes mandatory. There are no official fees during the voluntary registration process and the registrations will be honored when registrations are required..
*** Labeling and IFU must be submitted in English; however, if your device is to be used by consumers, copies must also be submitted in Chinese.
**** Device labeling must also comply with local requirements as set forth in COP-01 (Code of Practice for Local Responsible Persons) and TR-005 (Additional Medical Device Labeling Requirements).
This is a simplified overview of the process. The Hong Kong MDCO will likely audit your submission and request more documents, which will add time to your approval.
Remember the company put out a press release back in January before this became as widespread as it currently is.
https://finance.yahoo.com/news/cytosorb-wuhan-coronavirus-cytokine-storm-120100937.html
Ever since the Ebola crisis in 2014 and including the SARS outbreak in 2016 the company's strategy for outreach has included reaching out to many different organizations including the World Health Organization, the FDA, the CDC as well as government agencies such as USAMRIID and even non profit organizations and hospitals. These agencies as well as the NIH are aware of the therapy, so it's not the company's fault.
Each of these agencies has a different mission and focus, but what would bring them together in this country is this 319 process:
https://www.cdc.gov/flu/pandemic-resources/planning-preparedness/regulations-laws-during-pandemic.htm
"The HHS Secretary may, under section 319 of the PHS ActExternal determine that a disease or disorder presents a public health emergency; or that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists. Following a section 319 declaration, the Secretary can take many actions during an influenza pandemic, including making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder..."
"Section 564 of the FD&C Act (FDA), authorizes the HHS Secretary to declare an emergency justifying the emergency use authorization (EUA)External of medical countermeasures (MCMs) during public health emergencies. When an EUA is declared, the FDA Commissioner can allow either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear (CBRN) agent. For example, during the 2009 H1N1 influenza pandemic, the FDA approved the emergency use of antivirals for certain patients and health care settingsExternal."
WHO report out of Thailand today reports a 30-year-old man on extracorporeal membrane oxygenation (ECMO), also known as extracorporeal life support, which is a technique of providing prolonged cardiac and respiratory support to a person whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion.
https://reliefweb.int/report/thailand/coronavirus-disease-2019-covid-19-who-thailand-situation-report-15-february-2020
The CytoSorb Therapeutic ECMO™ Kit combines the market leading CytoSorb blood purification cartridge - the only specifically approved extracorporeal cytokine adsorber in the European Union - with an innovative, patent-pending tubing connector set that allows the easy integration of CytoSorb into the blood circuit of most commercial ECMO machines.
https://www.prnewswire.com/news-releases/cytosorbents-introduces-the-cytosorb-therapeutic-ecmo-kit-at-the-2017-european-society-of-intensive-care-medicine-congress-300525708.html
Raptor, you and me both. It's not out of the realm of possibility, but until China asks for assistance from CDC and WHO for assistance, no company is going to be able provide prevention or treatment options to them. It's sad to see their citizens suffering because of the government.
Meanwhile let's hope that this article gets more eyes on it in our country and other parts of the world: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153725534
'It's Coming': CDC Director Warns Coronavirus To Become Widespread Throughout United States, 'Probably Beyond 2020'
https://www.zerohedge.com/health/its-coming-cdc-director-warns-coronavirus-become-widespread-throughout-united-states
Add one more unlikely black swan event: Coronavirus
I saw this posted today and even if this guy is partly correct, this thing is still not contained and is expanding.
In Shocking Admission, WHO Advisor Says Coronavirus May Infect Over 5 Billion People
https://www.bloomberg.com/news/articles/2020-02-13/coronavirus-could-infect-two-thirds-of-globe-researcher-says
"In yet another sign of the World Health Organization's about-face on the coronavirus outbreak, a top epidemiologist and advisor to the organization said Thursday that if the virus isn't contained soon, it could infect 60% of the global population - or more than 5 billion people - echoing projections made by a Hong Kong scientist who was once labeled an alarmist despite his pioneering work in the fight against SARS.
According to Bloomberg, that's what WHO advisor Ira Longini said after finishing a study of the virus's transmissibility. His estimates suggest that the virus could one day infect billions of people, far more than the ~60,000 or so cases as of earlier on Thursday.
If the virus truly has a mortality rate of 2% (around the low end of current estimates), at this rate, it would kill more than 100 million.
Of course, if the virus manages to spread so widely, it will unequivocally prove that China's draconian quarantines weren't effective enough, and that the government effectively set itself up for failure when it hesitated to try and contain the outbreak after it first emerged in Wuhan late last year."
On or before the next earnings call, the stock should have at least a temporary increase in price if they (A) announce finally that the HemoDefend IDE has been submitted and approved. This removes a lot of uncertainty and finally puts a stake in the ground for the trial to actually get started, (B) provide an update on an execution plan and any revisions to the REFRESH 2 trial and a timeline for resuming, or (C) provide an indication as to whether the REMOVE trial achieved their primary endpoint and if the over-enrollment is complete, which would provide a indication of a positive readout sometime in the next several months. There is always the possibility of a black swan event such as a CAR-T partnership announcement that could be a significant catalyst, but I would temper my expectations for such.
In short there is really no identifiable catalyst until some of these major trials get further along, or if something new comes out of the next earnings call.
From YMB (hofno): "Sepsis is a common cause for cerebral dysfunction - because in a septic shock situation the brain may lose its ability to maintain the physiologically needed blood pressure range by auto-regulation. Regaining control on the blood pressure in hemodynamically unstable patients may prevent therefore negative cerebral effects in sepsis/septic shock."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515688/
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination (SepsAR3)
New trial initiated in Germany:
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination (SepsAR3)
Brief Summary:
The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.
https://clinicaltrials.gov/ct2/show/NCT04259567
Sponsored by Johannes Gutenberg University Mainz
New alternative to antidotes for novel oralanticoagulants and ticagrelor in the case of severe bleeding
Just published (Feb 11, 2020)
Patrick M. Honore, Christina David, Rachid Attou, Sebastien Redant, Andrea Gallerani & David De Bels
Critical Care volume 24, Article number: 48 (2020) Cite this article
The original article was published in Critical Care 2019 23:206
"Kuramatsu et al. reviewed current therapies for reversal of new oral anticoagulants (NOACs) and anti-platelet agents in patients with acute intracerebral hemorrhage [1]. In their comments on “Unspecific reversal approaches,” we believe that the authors have overlooked another new way to reverse this anticoagulation, especially with NOACs such as rivaroxaban and dabigatran and the new antiplatelet drug, ticagrelor [2]. In the case of severe intoxication with these NOACs or new anti-platelet agents, there is a promising new therapy based upon the use of the CytoSorb device [2]. CytoSorb can very efficiently remove NOACS and anti-platelets agents in order to restore normal coagulation and platelet function and to stop bleeding wherever it is occurring [2]. In their study, Angheloiu et al. were able to remove 99% of ticagrelor from human blood in less than 4?h when using CytoSorb [2]. They concluded that CytoSorb can remove representative molecules from two classes of agents—antiplatelet and anticoagulant—and in the future could complement the use of a newly developed specific monoclonal antibody reversal agent for ticagrelor, which is still in the pre-clinical phase and not yet available at the bedside [3]. In other experimental work by Koertge et al. [4], it was found that more than 91% of rivaroxaban could be removed from the blood during 1?h of use of CytoSorb [4]. This new therapy could perhaps complement the use of the antidote andexanet alfa [1], particularly if the antidote is not immediately available [4]. Lastly, Hassan et al. reported the intra-operative use of CytoSorb adsorption of ticagrelor and rivaroxaban in emergency open-heart surgery [5]. They concluded that this strategy is a safe and effective method to reduce bleeding complications induced by ticagrelor and rivaroxaban in that setting [5]. Studies comparing the two strategies (sorbents versus monoclonal antibodies) are urgently needed."
https://ccforum.biomedcentral.com/track/pdf/10.1186/s13054-020-2760-7
Agree that any news on this front will cause at least a major spike in the stock price. However I think there are several hurdles to getting the filter into hospitals in China.
Our distributor Chong Lap (H.K.) Co. Ltd. is only licensed to distribute CytoSorb in Hong Kong. Hong Kong has its own medical device regulations, separate from mainland China and to my knowledge the product registration which was started in 2018 has not yet been approved for Hong Kong. There is a chance that the Medical Device Control Office (MDCO) in Hong Kong could expedite the product registration or provide an exemption, but to get the filter into the mainland you have to deal with China's equivalent of the FDA which is the Centre for Medical Device Evaluation (CMDE). The CMDE itself has an application process for special examination of innovative medical devices and perhaps again this could warrant an exemption or expedited approval.
More interestingly is the fact that there is a device in China already. Are you familiar with the Jafron HA330-HA cartridge? From my limited reading the clinical experience with the Jafron HA cartridges is mainly limited to China. HA330 is a counterpart to Cytosorb and is a sorbent-based treatment for acute severe inflammatory disease and in particular has shown to be effective against acute respiratory distress syndrome (ARDS). I was wondering whether the Jafron device is being used in hospitals now to treat the nCoV victims. Below are a few links that might be informative.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6355888/
https://www.karger.com/Article/Abstract/505565
http://www.burrillandco.com/pz2d3cfec-cz28c7d2-ha-resin-hemoperfusion-cartridge-product-ha330-ii-for-liver-diseases.html
As we have seen China is a black hole when it comes to factual news, so who knows what they are doing to combat this. What we do know is:
1. 60 million people are currently locked up in their homes in China
2. 50,000 new cases a day (estimated)
3. Infections doubling every 5 days
4. Death rate is still unknown
5. China likely to peak in March
6. Epidemic peak is still a month away
7. It will be very hard to control this epidemic the way SARS was 15-20 years ago
8. Cases are always underestimated
9. Death delays are as long as three weeks
10. We still don't know the full effects
For comparison purposes, the state of California has about 40 million people. Illinois has 13 million. Michigan has 10 million. So imagine everyone in CA, IL, and MI being locked in their houses, unable to leave other than to buy groceries every three days.
Pretty crazy.