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Sunday, November 22, 2020

Chinese Flu: Things Are Moving At Warp Speed -- November 22, 2020

Yesterday, we got word that the FDA has approved Regeneron's two-multiclonal-antibody cocktail for treatment for those diagnosed (and symptomatic) with Covid-19.

Now, tonight, it is being reported that the first Covid-19 vaccine may be available for health workers as early as December 12, 2020.

Futures across the three major indices are up modestly. If all this news is "digested" tomorrow and all things being equal, it could be an interesting day on Wall Street. Good luck to all.

Disclaimer: this is not an investment site.  Do not make any investment, financial, job, career, travel, or relationship decisions based on what you read here or think you may have read here. 

By the way, with regard to the vaccine the conversation has changed. No longer are we talking about IF, and even the question of WHEN is starting to be "so yesterday." We are now seeing CEOs of the various vaccine companies telling us WHY their vaccine is better. Truly amazing how fast things seem to be moving.

Re-posting:

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Regeneron

Re-Gen-a-Ron -- accent on second syllable.

Re-Gen-i-Ron -- accent on second syllable.

I don't know if that's correct but that's how I remember it.

Chinese flu news: FDA authorized emergency use of antibody treatment given to President Trump. Timing was interesting. 

Approved after the election. The "deep state" is starting to change the narrative. Keep approving more treatment regimens; release the vaccines; and the new administration can "follow the science" and not mandate a return to more draconian measures. The new administration has to flatten the curve within three months, prevent a third wave, and declare an end to the pandemic within twelve months if they hope to make gains in the mid-term elections. Link here for the Regeneron story; the comments are most interesting, as  usual. 

The Regeneron solution is a "cocktail" of  two monoclonal antibodies, which, of course, to 99.99% of the lay public, means nothing...."monoclonal what ...":

  • REGN10933: casirivimab
  • REGN10987: imdevimab

Regeneron is traded on NASDAQ (REGN). 

Background for monoclonal antibodies:

The development of monoclonal antibodies by Georges Köhler and César Milstein, in their attempt to understand the mechanisms by which cells of the human immune system are capable of producing so diverse a repertoire of antibodies, was recognized in the award of the Nobel Prize for Physiology or Medicine in 1984, shared with Niels Jerne. 
In the last two decades such antibodies have been used to treat a wide range of conditions, including malignancies and autoimmune disorders. 
New techniques for synthesizing monoclonal antibodies now make it possible to use transgenic mice to generate antibodies similar to human antibodies. 
A virus infection, due to Ebola virus, has been treated in successful experiments using either humanized antibodies generated from mice or antibodies obtained from convalescent human patients. 
This suggests the possibility of treating COVID-19 with monoclonal antibodies directed against structural elements of the virus. Fusion of coronaviruses with human cells requires “docking” of specialized glycoproteins, “spikes”, which protrude from the viral surface and interact with specific molecules on the surface of host cells. 
The virus binds, through the spike protein’s receptor binding domain, to a membrane bound enzyme, ACE-2, and its entry into the cell is activated by a transmembrane serine protease, TMPRSS2. The spike protein, whose sequence differs greatly from one type of coronavirus to another, presents a target for therapy by antiviral antibodies.

That article goes on to explain the number of genomes identified and kept in the company's "library" of genomes and why the company decided to go with two antibodies in the cocktail. Brilliant. Absolutely brilliant. 

The FDA press release here, released yesterday, Saturday, November 21, 2020. 

Today, the U.S. Food and Drug Administration issued an emergency use authorization for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. 
This includes those who are 65 years of age or older or who have certain chronic medical conditions
In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated. Casirivimab and imdevimab must be administered together by intravenous (IV) infusion.

There is more that could be written but time to move on. 

From my perspective: under an Obama administration, The New York Times Sunday edition headline: Cure For Covid-19 Approved. National Nightmare Is Over. Index case, 74-year-old male with significant co-morbidities, symptomatic for Covid-19; less than 72 hours in the hospital after being treated with this regimen.

We won't see that headline until January 21, 2020. 

By the way, if this works, one can expect mini-step-up Covid-19 units -- not ICUs -- in which once patients have been examined, tested, and given presumptive diagnosis of Covid-19, will immediately be given the intravenous cocktail, admitted to a 72-hour step-up unit and treated there. Most will be discharged after 72 hours; some will be released sooner and treated as outpatients; some will require transfer to ICU. Here in north Texas there are a lot of under-used stand-alone emergency rooms, perfect for 72-hour-step-up-treatment. But the Medicare and insurance reimbursement must be "substantial" for this to happen.

All things being equal, the market should do very, very well. In some regards, a proven treatment regimen is better than a rushed vaccine.

The letter in PDF format can be found at this link. This is a screen shot of the first page of many pages:

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