Doubling Down On These China's COVID-19 Bio-Tech Disrupters 

Mesoblast (Nasdaq: MESO) said the FDA issued a complete response letter at 7:25 PM 10/1/2020 to its BLA for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease. The FDA has sought the company to conduct at least one additional study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD.

Mesoblast said it will urgently request a Type A meeting with the FDA, which could be held within 30 days, to discuss a potential accelerated approval, with a post-approval condition for an additional study as I had confirmed by being on the Conference call on October 1, 2020, at 7:45 PM ET.

The FDA also identified a need for a further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity, the company said, but further stated, "their Emergency Use Authorization's for remestemce-L for SR-aGVHD and current phase II/III trials for patients suffering from the more critical China COVID-19 Virus Strains. We know now, the incredible combinations in that treating physicians on the frontlines now have another critical disrupter in the compassionate use status and right to use as President Trump enacted within his own battle as we pray he will come out of this wicked killer China virus, as he possibly contracted over 5-7 days ago.

We see MESO price targets compared to their Fair-Price between $38-$45 dollars a share with H.K. Wainwright confirming their BUY with PT $19 from their current trading price at between $12.60 to $12.81 at 10:12 AM 10/5/2020. We added already an additional 25,000 shares when Mesoblast LTD traded down as low as $10.20 a share with our dollar cost average at $13.65 a share for a total position at 48,575 shares held with the same thought as the story of "     "

That grim news may be why the markets were down 0.7% last Friday but opened Monday with money coming off the sidelines. The stocks of vaccine pure plays -- like Moderna (MRNA), up to .78 at 10:29 AM BioNTech (BNTX), UP .75, and Novavax (NVAX) up to $4.75 -- rose. (REGN) up to $34.65 Monday morning 10/5/2020 that we added 500 shares at $543.65 Friday 10/2/2020 from Jim Cramer's recommendations from CNBC Mad-Money gave two thumbs up on getting in all any pullbacks. 

Treatments for infected people like Trumps are far better now than in the spring. Gilead Sciences (GILD) has an authorized treatment in Remdesivir deliver, which it sells under the brand name Veklury, and its stock was up fractionally, at $63.68 on 10/05/2020.

On Thursday, the company announced that it had ramped up production of the antiviral and could supply enough Veklury for all of the hospitalized COVID patients authorized to take it. Starting yesterday, the company took over the distribution of the drug from a federal emergency program. Three clinical trials showed that the Gilead drug speeds the recovery of those hospitalized with COVID.

We see Regeneron Pharmaceuticals (REGN) from last week reported preliminary results from a trial of an infusion of two antibodies. The antibody cocktail sharply reduced virus levels in test subjects, who were nonhospitalized COVID patients like the president. It was only a Phase 1 trial, but Regeneron executives expressed hope that authorities would allow the use of the treatment while the company finishes other, more robust studies.

With COVID vaccine trials expected to yield results in the next month or two, many investors have reduced their expectations for the sales of treatments like those from Gilead and Regeneron. But Friday, we read out of Bernstein analyst Ronny Gal, he argued that Regeneron could still find a $3 billion market for antibody treatments in 2021 while vaccines work their way into the population. We also feel the need again for the still approved for EUA's as actively conducting Phase I/II/III trials given the status as being Block-Buster Disrupters; like (MESO) remestemce-L and (CAPR) CAP-1002 in the Severe ICU or pre-ICU COVID patient battling to stay alive and stay off being intubated getting off being intubated with the use Accelerate Diagnostics (AXDX) Accelerate said in April that it would market, commercialize and support BioCheck Inc.'s MS-FAST immunoassay analyzer and SARS-CoV-2 tests.

EVERYONE NEEDS TO GET TO KNOW:

Accelerate Diagnostics Announces New FDA Clearance for Accelerate PhenoTest® Improvements

TUCSON, Ariz., Sept. 16, 2020,/PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX) today announced that the Company has received U.S. Food and Drug Administration (FDA) clearance for a new suite of product enhancements to the Accelerate Pheno® system, which improves performance and expands the system's antimicrobial susceptibility testing (AST) menu for bloodstream infections.

The system targets the S1 protein. Accelerate said, "the S1 protein has the fewest similarities to other coronaviruses, which allows for a lower probability of false positives due to cross-reactivity."

MUCH COVID-19 HOPEFUL TREATMENT THERAPEUTICS

We believe that Regeneron could charge $2,000 per treatment. Of a $3 billion market in 2021, we think the company can get $1.1 billion, with the others like many higher and more accepted Exosome COVID-19 Vaccines such as Capricor's (CAPR) VLP and mRNA out of John Hopkins world-renowned Dr. Gould heading these Exosome vaccines into trials in the very near future are huge Disrupters as reported by Capricor.presentation last Thursday 10/1/2020.  We feel again, this all imparts due to the efforts made when the fight President Trump has pushed from first learning the China Plague, has continued his Administration's Policies within unprecedented PROJECT-WARP-SPEED initiatives pushed as Trump's war waged on China's COVID Virus.

The product developed by Pfizer (PFE) and BioNTech is the first vaccine trial expected to yield results. The companies say they expect conclusive results by the end of October. Pfizer stock was up to .38 on Monday 10/05/2020.

The companies designed a trial that could give the study's monitoring committee an earlier peek at the data than the trials of rivals like Moderna. Pfizer CEO Albert Bourla circulated a letter to the company's employees this week, reassuring them -- and the public -- that his hopes for early results and government authorization were driven by medical needs, not November's election.

COVID vaccines should be evaluated on an independent scientific basis, CEO Bouria said, not politics.

We feel Moderna (MRNA), Novavax (NVAX), AstraZeneca (AZN), Inovio (INO), including we feel Johnson and Johnson (JNJ), Eli Lilly (LLY) sharing the rest. After next year, we think there will still be a $500-million-a-year or more in the market for China's COVID Plague with any future Biological Time Bombs that may be released upon a world now mobilized within antibody treatments and cutting edge vaccine development abilities.

Capricor Therapeutics Inc (Nasdaq: CAPR) is scheduled to present at the WMS Congress, novel data from its Phase 2 HOPE-2 clinical trial of lead asset CAP-1002, in boys and young men with Duchenne muscular dystrophy. (Was on Thursday 10/1/2020 in the afternoon). The news out of this presentation was incredible, including their efforts in the Exsome vaccine platform never created until now out of John Hopkins brain trusts of Dr. Stephen Gould. 

We are remaining prayerful and hopeful and feel the FDA will reward Capricor Therapeutics with many positive drug approvals as we have recognized already their many successes to date. Furthermore, these efforts have been under PROJECT-WARP-SPEED by President Trump himself and not by any Democratic candidate that has become the face for the Democrats as former vice-president Joseph Biden's as nor we have stated, many times prior, as our LEFT-WING MEDIA and fake news outlets seemingly to date, them being absent in only pushing a NEGATIVE CAMPAIGN polarizing MUCH FEAR within China COVID-19 ONGOING plague. I haven't seen them pushing all these incredible COVID-19 Treatment Weapons as I just listed. It still seems the Democratic Parties Platform is still ONE BASED ON A CULTURE OF DEATH and not that of EVERY LIFE MATTERS; FROM THE WOMB TO THE TOMB.

We will clearly state for the record, that Vice-president Joe Biden has had NO-PLAN offered AT THE MOST RECENT DEBATE or has he posted to date, either on the DNC website or any other we can find, actually helping rebuild from our entire country put on lockdown in March by President Trump. It's believed if a Biden Presidency results from November 3rd, Biden would have to continue PRESIDENT TRUMP'S TRUE PROJECT-WARP-SPEED, but Biden would move to close off the economy once again, though truly closing down our entire ECONOMY starting in 2021 most likely again, with untold consequences.

The economic disaster is cataclysmic if we see a Democratic Presidency or Republican losses for seats within the U.S. Congress and those seats up for election in the Senate. All of these quite scary, and only a vote away on November 3rd, if one casts theirs for Joe Biden instead of the re-election of President Donald J. Trump for another 4 years. A Biden Presidency again would be causing our country in entering the GREATEST DEPRESSION EVER SINCE 1929. 

We have only seen the running elites within the Democratic Party since all of them were running for the highest office as President of the United States, never have been part of the solution against China's SARs-CoV2 first came to our American shores, back in most likely December 2019, and HIDDEN by China's Communistic Party, and trying in projecting themselves as progressive Socialistic Society or better yet, known as Senator Bernie Sanders and the DNC Candidate Joe Biden face of the democratic parties radical Socialism platform that BIDEN HAS GONE SO FAR LEFT he always appears out of it.   

The Spread of China's COVID-Plague Throughout The West-Wing of the United States  

The number of confirmed U.S. cases of the coronavirus that causes COVID-19 rose to over 7.4 million on Sunday and now includes President Donald Trump and first lady Melania and at least ten or more others in their circle, with more people expected to test positive from a Rose Garden event last weekend and others over the past week. 

Both of those factors increase the risk for people diagnosed with the disease. According to the Centers for Disease Control and Prevention: Having obesity increases the risk of severe illness (https://www.cdc.gov/obesity/data/obesity- and-COVID-19.html) from COVID-19, and may triple the risk of hospitalization. The path of the unpredictable virus is related to immune function, and reduces lung capacity and reserve and can make ventilation more difficult. As the body- mass index increases, the risk of fatality from COVID-19 increases, it added.

"People in their 60s or 70s are, in general, at higher risk for severe illness than people in their 50s," the federal agency said. However, the president isn't in the highest-risk age group: "The greatest risk for severe illness from COVID-19 is among those aged 85 or older. There are also other factors that can increase your risk for severe illness, such as having underlying medical conditions," the CDC said. "As you get older, your risk of being hospitalized for COVID-19 increases."

Still, doctors have only been treating China's COVID-19 Plague for about nine months at the most. The standard of care is still evolving as we have kept our readers up to the most current treatments being used from around the world, The definitions of mild and moderate disease and the criteria that make people eligible for unapproved treatments range widely again throughout the world's war against this china plague. Dr. Stephen Hayes, M.D., and his effect has been a rapid learning curve treating all age groups who have become positive with symptoms from SARsCoV2. Dr. Hayes stated to me, "that recent reports from Trump’s physician, that the President’s oxygen levels dropped twice or more since contracting this deadly pandemic, would qualify him as a moderately ill patient and therefore make him eligible to be treated with both Remdesivir and Dexamethasone with the additional use of Vitamin-D, Zinc, Melatonin, Famotidine Pepcid, Supplemental Oxygen when needed, and Asprin."

“At some point in time, President Trump's dropped his oxygen levels below 94% and he was put on oxygen,” Dr. Hayes says. “You don’t need to be on oxygen, [you] just need to reach that point. And once it’s reached, he is a candidate for the EUA by the FDA as well as the EU authorities for Remdesivir and dexamethasone. Trump has kissed that goal post, and once you hit that goal post that’s all you need to do. If I were his physician I would say he needs to be on them. You don’t wait for the patient to remain with low oxygen levels.”

In a Sunday press conference, Conley said that Trump is not currently on supplemental oxygen, but stated Monday morning, Trump had been put on supplemental oxygen late Sunday evening for only a while, in that we now can gather Trump has had three episodes during which his oxygen saturation levels dipped, after which the team had decided to continue his dexamethasone. Conley also intimated that the President’s lung images were “typical” of what doctors would expect in a COVID-19 patient. However, he did not answer questions about what the images showed—such as whether there was evidence of pneumonia. “We don’t know if he has pneumonia, but his doctor said the findings were typical of what we might expect, so that means it wasn’t totally normal,” says Dr. Hayes. “We don’t know for sure.”

While Trump may have been prescribed dexamethasone as a preventive measure, it has potential side effects, which is why most doctors are judicious about using it. While studies show it can help lower mortality among COVID-19 patients by anywhere from a fifth (for those requiring supplemental oxygen) to a third (for those on ventilators) compared to those not receiving it, it also inhibits the immune system and can make people more vulnerable to bacterial infections.

From an article piece out of TIME author Alice Park, as she wrote “Steroids are immune-suppressing, so you run the risk of predisposing someone to secondary infections,” says Dr. Bryan McVerry, an associate professor of medicine at the University of Pittsburgh who recently published a study on corticosteroids in COVID-19 patients. “The data certainly does not support the use of corticosteroids at that stage of illness. What we are hearing from reports is that the President seems to be a milder case so I’m not sure I would necessarily use dexamethasone. But I’m not there, and it’s hard to speculate about that and the doctors taking care of him are good doctors so I trust they are weighing the evidence in their decision making.”

Dr. Hayes contends that the drop in Trump’s oxygen saturation levels alone could qualify him as having severe disease. “[His doctors] said at some point in time it dropped below 94%, and the moment it drops below 94% you have severe disease,” he says. “They never used those words but in reality, he had severe disease. Everything then fits.”

It may be a matter of semantics, or a more crucial matter of clarifying the still-fuzzy timeline of when the President first felt symptoms and when he was diagnosed, which neither Conley nor anyone else from the White House has done. If Trump has been battling COVID-19 for longer than several days, the treatment course fits more closely with that of most virus patients today as my reflections as a Forensic Analyst quantitates. If he has only been infected for a few days, then his treatment strategy would seem more aggressive and pre-emptive than the typical regimen—and considerably riskier. As I have learned from Dr. Hayes that very few if any, COVID-19 patients have been tested with monoclonal antibodies and then given remdesivir—most of the Remdesivir data we have were collected before researchers began testing the newer antibody therapy. And similarly, only a small percentage of the patients in the U.K. dexamethasone study received remdesivir, so it’s unclear whether or how the drugs might interact or affect patient outcomes.

“What is unprecedented is that no one has received remdesivir after getting monoclonal antibodies as an outpatient,” said Dr. Hayes. “Anyone who was on a prior trial of remdesivir would not have gotten antibodies beforehand.”

Whether the decisions to start the President on three unapproved therapies for COVID-19 prove risky or prescient will depend on his response over the next few days—and on how sick Trump really was when these decisions were made. Given that Conley admitted Sunday that he previously evaded questions on Trump’s need for supplemental oxygen because he “didn’t want to give any information that might steer the course of the illness in another direction,” that may never become clear. “How long has he really had symptoms? We don’t know, and we will probably never know,” said Dr. Steaphen Hayes.

What is the president's level of obesity?

The president does have something on his side in his regard: He is in the lowest-risk category in terms of obesity, according to the latest data on his weight and publicly available information on his height. Trump has a BMI of 30.1 based on a height of 6 foot, 3 inches, and a weight of 243 pounds, as written in a memo from Dr. Conley last year. That gives him a BMI of 30.1 and puts him into the lowest of three stages of obesity, according to the CDC's official definition.

BMI

BMI calculates weight, muscle, fat, and bone in relation to height and gender. A BMI of 25 to 29.9 is considered overweight and those with a BMI of 30 or more are considered obese; morbidly obese people have a BMI of 44.9 or more. " Patients who received invasive mechanical ventilation were more likely to be male, to have obesity," according to this study (https://www.nejm.org/doi/full/10.1056/NEJMc2010419) in the New England Journal of Medicine.

Age is another risk factor. Research on COVID-related fatalities shows the majority of those people are over 70. Genes in the body that appear to be a major factor giving SARS-CoV-2, the virus that causes COVID-19, access to the heart cells become more active with age, according to research published in August in the Journal of Molecular and Cellular Cardiology. The coronavirus spike protein binds to certain enzymes and proteins in the heart that are more common as we age.

Inflammation in older people can be more intense, causing organ damage, according to Johns Hopkins University. "Lung tissue becomes less elastic over time, making respiratory diseases like COVID-19 a particular concern for older people. The CDC added, "Eight out of 10 COVID-19-related deaths reported in the United States have been among adults aged 65 years and older." However, the risk of dying from COVID-19 increases more for those who are 85 and older.

It takes significantly longer to recover from the disease for older people, studies show (https:// www.ncbi.nlm.nih.gov/pmc/articles/PMC7229949/), but the virus can be pernicious in how it impacts people, and what symptoms -- if any -- continue to linger. For instance, the U.K.'s Prince Charles, 71, made a full recovery from the virus. Most people recover within a few weeks, Mayo Clinic researchers recently wrote some-COVID-19-patients-suffer-lung-and-heart-damage-but-there's-encouraging-news-for-these-long-haulers-2020-09-07), "but some people -- even those who had mild versions of the disease -- continue to experience symptoms after their initial recovery."

Why are older people more at risk? 

Adult patients can respond to coronavirus infection with an over-vigorous adaptive immune response that may promote the inflammation associated with acute respiratory distress syndrome," a type of serious lung damage now associated with severe COVID-19 cases, health professionals say. For instance, doctors and members of the public were spooked by how otherwise strong, healthy people fell victim to the 1918 influenza.

Doctors today attribute that phenomenon to the "cytokine storm" or hypercytokinemia, a process where the immune system in healthy people reacts so strongly as to hurt the body. A hallmark of some viruses: A surge of immune cells and their activating compounds (cytokines) effectively turned the body against itself and led to an inflammation of the lungs and severe respiratory distress, leaving the body vulnerable to secondary bacterial pneumonia.

A study released last month in Science Translational Medicine, an online journal that publishes research at the intersection of science, engineering, and medicine, offered a theory on why older patients' immune systems fare worse. It suggested adult patients respond to coronavirus infection with an over-vigorous, but less effective "adaptive" immune response, whereas children respond with a more effective "innate" immune system.

Coronavirus Update

The Dow Jones Industrial Index, the S&P 500, and the Nasdaq Composite all closed lower Friday in the wake of the president's diagnosis; the Nasdaq was down 2.2% at day's end. Doubts about traction for further fiscal stimulus from Washington may be another factor discouraging investors- Thursday-as-it-closes-in-on-record-ahead-of-jobless-claims-report-2020-09-03) who have been betting on Republicans and Democrats striking a deal to offer additional relief.

As of Sunday, COVID-19 has now killed at least 1,034,865 people worldwide, and 209,749 in the U.S., according to data aggregated by Johns Hopkins University (https://coronavirus.jhu.edu/data/mortality). (https://coronavirus.jhu.edu/data/ mortality) (https://coronavirus.jhu.edu/data/mortality) The U.S. still has the world's highest number of COVID-19 cases (7,412,911) due to active testing protocols set by the current policies being administrated by president Trump's, just ahead of now India (6,549,373) and Brazil (4,906,833). Worldwide, there have been at least (35,011,322) confirmed cases, which mostly do not account for asymptomatic cases.

SUMMARY IN OUR VIEWS

These times we are all experiencing throughout not only the huge implications in the Biological Weapon lobed over across China's borders. Our Country has learned an extensive amount in battling this lethal China COVID-19 virus. It also has learned you can't shut down an entire state or country and still confine stopping the spreading of this China Plague. The huge implications for extensive filings for chapter 11 or just closing the doors completely upon the small, medium, or even larger corporations is in play if we keep pressing for lockdowns in cities like being seen in the state of California and other Democratic-run, cities, counties, or as we have seen entire statewide closures.

Companies like Accelerate Diagnostics (AXDX), Mesoblast LTD, (MESO), Capricor Therapeutics (CAPR), and biopharmaceuticals like Spectrum Pharmaceuticals (SPPI). These companies are only a small example of many hidden gems that are either becoming prime for M&A activity or a surge like a rocketship moving much higher from their current share prices.  I have learned that Republicans and many Americans that believe in a true Culture of Life over a darkened Secular Agnostic Socialism Platform in continued pushing a Culture of Death, in that we still haven't seen the DNC machine actually open up their hidden voices who do have much faith and believe in Pro-Life, and especially keeping God throughout all the equations in our United States as truly united American Soul/Spirit in a Culture of Life, and again, EVERY LIFE-MATTERS; in these hidden forced Minority of Democratic having faith within a true higher power, as many Christians have placed their Faith, Hope, and our Countries many Acts in Charities and our God-fearing Love sent around the world.

These are our economic foundations on the ballot this year. Make Your Vote Heard and really counted but not twice or none existent mailed in Ballots being a true concern this election year. These are the principals since the founding of our great Nation in 1776, I can't become any blunter once again, the Majority voices have a chance as back in 2016 within the Democratic Party affiliation and Vote American Once again to actually turn the proposed DNC platforms placed upon our Ballot voted this November Tuesday 3rd for changing back these silent Minority pushing out the powerful message to the Left-Wing Extreme Elitesd and the message in moving towards a far RIGHT-WING with GOD in GOD WE TRUST our country was founded upon and we feel is being seriously in jeopardy this vote either for Trump or Biden.