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WHO warns pandemic speeding; worst to come
"Although many countries have made some progress, globally, the pandemic is actually speeding up," WHO chief Tedros Adhanom Ghebreyesus said during a virtual news conference.
The virus has infected more than 10.1 million people around the world and killed at least 502,634 people, according to data compiled by Johns Hopkins University.
"The single most important intervention is ... tracing and quarantine contacts," he said. "Six months since the virus started, it could be like a broken record to say exactly the same thing, but the same thing works. Test, test, isolate, quarantine cases."
“.....this is not even close to being over."
https://www.cnbc.com/amp/2020/06/29/who-warns-coronavirus-pandemic-is-speeding-up-as-countries-ease-lockdown-rules.html
This coronavirus mutation has taken over the world. Scientists are trying to understand why. “But the location was significant, because the switch occurred in the part of the genome that codes for the all-important “spike protein” — the protruding structure that gives the coronavirus its crownlike profile and allows it to enter human cells the way a burglar picks a lock.”
https://www.washingtonpost.com/science/2020/06/29/coronavirus-mutation-science/
We are a technologically disruptive company that has the most accurate and multi adaptive rapid test for COVID-19 and a wide array of additional infectious viruses, antigens and pathogens.
Over 500,000 people have been killed by Covid-19. https://www.cnn.com/2020/06/29/world/coronavirus-death-toll-cases-intl/index.html
READ: Using a Glucose Meter to Quantitatively Detect Disease Biomarkers Through a Universal Nanozyme Integrated Lateral Fluidic Sensing Platform
https://pubmed.ncbi.nlm.nih.gov/30544082/
READ: “Anyone and everyone can therefore be tested anywhere and everywhere to allow them immediately to act to seek professional help, which is especially essential during the COVID pandemic.
In this talk, we describe a novel design that combines the traditional POC lateral flow strip tests and electrochemical impedance sensor....
....POCT have been made during the past few years. For instance, the development of miniaturized biosensing devices with integration of functional materials, artificial intelligent, and internet of things, has been considered the most critical component of POCT for mass public testing; due to the increased test accuracy, fast response, precision, and easier connection and management of data.”
http://phantomsfoundation.com/ONLINE/Biosensors2020/Abstracts/Biosensors2020_Li.pdf
Bull flag on one day/one minute chart.
ALL WASTED TIME AND WASTED RESOURCES:
Fauci says task force 'seriously considering' new testing strategy
https://www.cnn.com/2020/06/26/politics/anthony-fauci-testing-coronavirus-task-force/index.html
U.S. Sets Daily Record For New COVID-19 Cases
https://www.npr.org/sections/coronavirus-live-updates/2020/06/26/883799638/u-s-sets-daily-record-for-new-covid-19-cases
Very serious stuff.
https://pdfpiw.uspto.gov/.piw?docid=09395321&PageNum=2&IDKey=F1C96D4CF9F1&HomeUrl=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2%2526Sect2=HITOFF%2526p=1%2526u=%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r=1%2526f=G%2526l=50%2526co1=AND%2526d=PTXT%2526s1=%252522THE%252BBIO%252BCO,%252BLTD%252522%2526OS=%2526RS=
https://pdfpiw.uspto.gov/.piw?docid=09395321&PageNum=3&IDKey=F1C96D4CF9F1&HomeUrl=http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2%2526Sect2=HITOFF%2526p=1%2526u=%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r=1%2526f=G%2526l=50%2526co1=AND%2526d=PTXT%2526s1=%252522THE%252BBIO%252BCO,%252BLTD%252522%2526OS=%2526RS=
Coronavirus vaccine will not be a cure-all, virologist warns
https://www.cnbc.com/2020/06/26/coronavirus-vaccine-will-not-be-a-cure-all-virologist-warns.html
Public health experts are increasingly frustrated with America's lack of leadership on coronavirushttps://www.cnn.com/2020/06/26/us/public-health-politics-coronavirus/index.html
Texas pauses reopening as hospitals inundated with 'explosion' of COVID-19 cases
The governor of Texas hit the brakes on reopening his state Thursday as hospitals were inundated with “an explosion” of new COVID-19 cases and officials warned there might not be enough beds available.
“The last thing we want to do as a state is go backwards and close down businesses," Gov. Greg Abbott said in a statement. "This temporary pause will help our state corral the spread until we can safely enter the next phase of opening our state for business."
https://www.nbcnews.com/news/us-news/texas-governor-pauses-state-s-reopening-due-spike-new-covid-n1232118
Texas pauses reopening plan and elective surgeries as coronavirus cases and hospitalizations rise
https://www.cnbc.com/2020/06/25/texas-gov-abbott-pauses-states-reopening-plan-as-coronavirus-cases-hospitalizations-rise.html
A rush to reopen caused the spike in new coronavirus infections, health expert argues
A spike this week in U.S. cases of the novel coronavirus was caused by a rush to reopen the nation’s economy without proper safety measures in place, Ashish Jha, director of the Harvard Global Health Institute, said Thursday on the “Today” show.
State health departments reported 38,115 new infections on Wednesday, the highest single-day caseload in the United States since the pandemic began. Texas, Florida and California reported the most cases, with more than 5,000 each.
https://www.washingtonpost.com/nation/2020/06/25/coronavirus-live-updates-us/
U.S. hits highest single day of new coronavirus cases with more than 45,500, breaking April record
https://www.nbcnews.com/news/amp/ncna1232065
At least 17 high school students test positive for coronavirus after a trip to Myrtle Beach
CNN)At least 17 Ohio high school students tested positive for coronavirus after a recent trip to Myrtle Beach, when they returned to a county that had previously reduced infection rates to zero.
Robert Sproul, Deputy Health Commissioner of the Belmont County Health Department, tells CNN that nearly 100 students from the Ohio Valley traveled to the South Carolina town and returned the weekend of June 13. The trip was not a school sanctioned event.
As of Tuesday afternoon, the Belmont Health Department confirmed the 17 positive cases as well as two contact positives -- people who were exposed to the students that went on the trip and tested positive. Sproul expects that number to increase as more people who went on the trip and the individuals they were exposed to get tested for the virus.
https://www.cnn.com/2020/06/23/us/ohio-students-myrtle-beach-coronavirus-trnd/index.html
SYSTEMS AND METHODS FOR ELECTROCHEMICAL HEMATOCRIT DETERMINATION BY ALTERNATE CURRENT IMPEDANCE PHASE ANGLE DETERMINATIONS
http://www.freepatentsonline.com/y2016/0146750.html
From Friday there’s been more than 371,559 cases of the coronavirus in New York, including 205,834 in New York City. More than 29,438 people with COVID-19 have died in the state, including people with probable, but not confirmed, cases of the virus.
Nationwide, over 1.7 million cases of COVID-19 have been confirmed across all 50 states, Washington, D.C., and three U.S. territories. More than 101,635 Americans have lost their lives to the virus. COVID-19 has killed more than 361,249 worldwide — and far more in the U.S. than in any other country. Roughly one out of every eight people killed by the disease in the world lived in the tri-state area.
https://nymag.com/intelligencer/amp/article/new-york-coronavirus-cases-updates.html
French defy lockdown with Festival of Music
https://www.bbc.com/news/world-europe-53138300
South Korea confirms second wave of infections
https://www.bbc.com/news/world-asia-53135626
South Korea confirms second wave of infections
WHO chief says COVID-19 pandemic still accelerating: Live updates
The WHO reported a record increase in global coronavirus cases as the total rose by 183,020 in a 24-hour period. The biggest increase was from the Americas, with more than 116,000 new cases.
https://www.aljazeera.com/news/2020/06/coronavirus-deaths-120000-live-updates-200621231628063.html
The world saw the largest daily increases yet in coronavirus cases over the weekend, though infections slowed in China and South Korea, suggesting progress in stemming their newest outbreaks. Despite clear progress in containing the virus in some regions, especially those that saw early outbreaks, the number of new cases has soared globally in recent days.
In Brazil, the United States, Iraq and India, many hospitals are scrambling to cope.
https://www.cbsnews.com/news/coronavirus-world-health-organization-biggest-one-day-cases/
TIME FOR BLAST OFF.
Patents: “Tae-young Lee” - - THIS PERSON IS AN ELECTRONICS GENIUS, FROM SAMSUNG AND PRODUCING FOR, “THE BIO.”
https://patents.google.com/patent/CN105069156A/en
For now, though, most people have not been infected and remain susceptible. And the highly transmissible disease has surged in recent weeks, even in countries that initially succeeded in suppressing it. Left alone, experts say, it will simply keep burning through the world’s population.
“This virus is here to stay,” said Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago. “The question is, how do we live with it safely?”
Combating endemic diseases requires long-range thinking, sustained effort and international coordination. Stamping out the virus could take decades — if it happens at all. Such efforts take time, money and, most of all, political will.
Americans have only started to wrap their heads around the idea, polls show. U.S. leaders and residents keep searching for a magic bullet to bring the pandemic to an abrupt end: Drugs that show even a hint of progress in the petri dish have sparked shortages. The White House continues to suggest summer’s heat will smother the virus or that it will mysteriously vanish. A vaccine — while crucial to our response — is not likely to eradicate the disease, experts say. Challenges to vaccination are already becoming clear, including limited supply, anti-vaccine opposition and significant logistical roadblocks.
Meanwhile, some states are rushing headlong into reopening their economies. Even those moving more cautiously haven’t developed tools to measure what’s working and what isn’t — a crucial feature for any prolonged scientific experiment.
People also keep talking of returning to normal, said Natalie Dean, a disease biostatistician at the University of Florida. But a future with an enduring coronavirus means that normal no longer exists. “As we find different ways to adapt and discover what works, that’s how we’re going to start reclaiming parts of our society and life,” she said.
https://www.washingtonpost.com/health/2020/05/27/coronavirus-endemic/
U.S. tops 2.25 million cases, leading the world in the pandemic.
As the U.S. topped 2.25 million known cases of Covid-19 over the weekend and deaths quickly approached 120,000, a top infectious disease expert compared the outbreak to a "forest fire."
"I'm actually of the mind right now, I think this is more like a forest fire. I don't think that this is going to slow down," said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at University of Minnesota, during an appearance on NBC News' "Meet the Press."
Dr. Osterholm said that in the early spring, he and a team of researchers were looking at different scenarios for the novel coronavirus, and how it compared to the typical cycle of the influenza virus. But on Sunday, he said that the influenza analogy no longer appears applicable.
"I don't think that this is going to slow down. I'm not sure that the influenza analogy applies anymore. I think that wherever there is wood to burn, this fire is going to burn. And right now we have a lot of susceptible people. And so, I think right now I don't see this slowing down through the summer or end of the fall. I don't think we're going to see one, two and three waves."
He also criticized the lack of a coherent national strategy to quash the outbreak.
While most states are already undergoing some type of reopening and former hot spots such as New York and Massachusetts are seeing an overall trend toward slowing outbreaks, other states, such as Arizona, have seen worrying spikes in cases, leading tech giant Apple (AAPL) - Get Report to close some stores again over the virus risks.
Nationwide, within one week from last Sunday, the U.S. saw its total known infection rate increase by more than 150,000 cases, according to the Johns Hopkins disease-tracking map.
Globally, around 8.8 million people have been diagnosed with the virus.
Brazil, which has more than a million known cases, and Russia, which has about about a half million known cases, are the world's other sites of large outbreaks. The crisis in Europe, meanwhile, especially in Italy and Spain, appears to be getting a rest.
Much of Asia, where the pandemic begin, has also seen its Covid-19 spread nearly halt. After implementing strict quarantines and lockdowns, China has officially stayed below 90,000 total cases, despite its vast population -- and some concerns of new cases and signs of coronavirus contamination at food markets. Singapore has keep its count below 43,000 and Japan -- which has been criticized as too lax over the virus spread -- has an official count at below 18,000. While some have questioned Japan's total count, a recent antibody testing initiative by SoftBank reportedly found a "positive rate" of 0.43% after giving out 44,066 coronavirus antibody tests to company employees and families and 500 medical institutions in Japan.
https://www.thestreet.com/latest-news/coronavirus-outbreak-compared-to-forest-fire
Top epidemiologist warns forest fire of C-19 cases. New York Times.
Eight states on Saturday reported their highest single-day case counts since the pandemic began, and daily new infections nationwide exceeded 30,000 on both Friday and Saturday. The country has not seen daily totals that high in more than seven weeks. https://www.washingtonpost.com/nation/2020/06/21/coronavirus-live-updates-us/
Covid-19 unmasks ..... world needs better & more equitable health system
Ironically, the fight against the coronavirus has required us all to don masks — and yet, it has taken the coronavirus, at a tragic and exorbitant human cost, to actually unmask and unmuzzle too many uncomfortable truths about a global health system that desperately needs investments and improvements to equitably care for all the patients who rely on it.
https://www.cnn.com/2020/06/20/opinions/covid-19-unmasks-what-cancer-patients-have-long-known/index.html
Tampa Bay Buccaneers report coronavirus cases at training center
The team said it would continue operations at its facility in Tampa, Florida.
https://www.nbcnews.com/news/us-news/tampa-bay-buccaneers-report-coronavirus-cases-training-center-n1231653
The Centers for Disease Control and Prevention (CDC) laboratories have supported the COVID- 19 response, including development of a diagnostic assay that was issued an Emergency Use Authorization (EUA) on February 4, 2020.4 Since authorizing CDC’s EUA, FDA has been actively working with other SARS-CoV-2 diagnostic test developers to help accelerate development programs and respond to requests for in vitro diagnostic EUAs.5 However, the severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity for the virus than is currently available.6
The EUA authorities allow FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures initiatives (MCMs) needed during certain public health emergencies. Under section 564 of the FD&C Act, the FDA Commissioner may authorize the use of unapproved medical products, or unapproved uses of approved medical products, in certain emergency circumstances, after the HHS Secretary has made a declaration of emergency or threat justifying authorization of emergency use, to diagnose, treat, or prevent serious or life- threatening disease or conditions caused by CBRN threat agents when certain criteria are met.
In addition, this guidance describes a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostic tests to laboratories for specimen testing after validation, while an EUA is being prepared for submission to FDA. This policy remains unchanged from the second publication of this guidance on March 16, 2020, though some process updates and clarification have been made as discussed further below.
As outlined in the May 4, 2020 update, FDA does not intend to object as described below where commercial manufacturers develop and distribute their serology tests after validation, for a limited period of time, while an EUA is being prepared for submission to FDA. Appendices with templates for such submissions have been added to facilitate and streamline the EUA process.
The policy for serological tests developed and used by laboratories that are certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing has not changed from the March 16, 2020 guidance, though FDA continues to encourage such laboratories to submit EUAs for their laboratory developed tests.
In the context of a public health emergency involving pandemic infectious disease, it is critically important that tests are validated because false results not only can negatively impact the individual patient but also can have broad public health impact. In this guidance, FDA provides recommendations regarding validation of COVID-19 tests based on the available information. FDA encourages test developers to discuss any alternative technological approaches to validating their test with FDA.
C. Commercial Manufacturer Development and Distribution of Diagnostic Tests Prior to EUA Submission
In light of the increasing numbers of COVID-19 cases throughout the country and the urgent need to expand the nation’s capacity for COVID-19 testing during the public health emergency, FDA does not intend to object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time, where the test has been validated and while the manufacturer is preparing its EUA request, where the manufacturer gives notification of validation to FDA as described below, and where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users.
FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test that has already been validated. Soon after receiving the EUA request, FDA will perform a preliminary review to identify if there are any problems with the performance data. If a problem is identified, FDA intends to work with the manufacturer to address the problem (e.g., through labeling or bench testing). If the problem is significant and cannot be addressed in a timely manner, and the manufacturer has already distributed the device, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test.
1. Validation
All clinical tests should be validated prior to use. In the context of a public health emergency, it is critically important that tests are validated because false results can negatively impact not only the individual patient but also can have broad public health impact. FDA has provided recommendations regarding testing that should be performed to ensure analytical and clinical validity in section V below. FDA encourages manufacturers to discuss any alternative technological approaches to validating their test with FDA through CDRH-EUA- Templates@FDA.HHS.GOV.
4. EUA Request
FDA has made available, through download from our website, templates that test kit manufacturers may choose to use to facilitate the preparation, submission, and authorization of EUAs for molecular and antigen diagnostics.14 Manufacturers can use alternative approaches. Manufacturers who intend to use alternative approaches should consider seeking FDA’s feedback or recommendations to help them through the pre-EUA and EUA process. FDA encourages manufacturers to discuss any alternative technological approaches to validating their test with FDA through CDRH-EUA-Templates@FDA.HHS.GOV.
Soon after receiving the EUA request, FDA intends to perform a preliminary review to identify if there are any problems with the performance data. If a problem is identified, FDA intends to work with the manufacturer to address the problem (e.g., through labeling or bench testing). If any problems are significant and cannot be addressed in a timely manner, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test, which should include a notification concerning corrected test reports indicating prior test results may not be accurate. In such circumstances, FDA intends to remove the manufacturer/test from the website listing of notifications.
https://www.fda.gov/media/135659/download
SEC IMPLICATED ITSELF WITH THE FOLLOWING SUMMATION, BELOW.
1. DECN announces that it is jumping into screening and testing for COVID-19 using the same technology first implemented in its diabetes test kit;
FACT
2. DECN makes first year product forecast of 420 million kit;
FACT
3. DECN announces that its “Swift Kit” will be offered to commercial labs and religious groups as 12 month forecast is raised to 525 million kits;
FACT
4. DECN announces FDA guidance allows for near immediate distribution of kits prior to Emergency Waiver Grants;
ABSOLUTE FACT: “In addition, this guidance describes a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostic tests to laboratories for specimen testing after validation, while an EUA is being prepared for submission to FDA. This policy remains unchanged from the second publication of this guidance on March 16, 2020, though some process updates and clarification have been made as discussed further below.
As outlined in the May 4, 2020 update, FDA does not intend to object as described below where commercial manufacturers develop and distribute their serology tests after validation, for a limited period of time, while an EUA is being prepared for submission to FDA. Appendices with templates for such submissions have been added to facilitate and streamline the EUA process.
https://www.fda.gov/media/135659/download
5. DECN announces that it received a “Pre-EUA Acknowledgement Letter.”
I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct.
FACT.
Dated: May 20, 2020
___________________________________ Carlisle Perkins, Senior Counsel
Securities & Exchange Commission Division of Enforcement
https://www.sec.gov/litigation/apdocuments/3-19788-event-2020-06-17-petitioner-brief-in-support.pdf