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Wonderful summary.The scene is being set for Brilacidin to enter every treatment regimen for not only Covid19, but many other viral disorders.
The lack of an effective antiviral treatment for Covid 19 may soon be over. With the poor results for other Covid19 antiviral treatments Brilacidin will move to the front of the line with postive Phase 2 results.
GLTA Farrell
I agree I have noted a change in trading over the last week.
I expect more strength as we move closer to the trial end and subsequent review.
GLTA,
Farrell
IPIX is not on the restricted trading list. Buying and selling IPIX is not limited by TD Ameritrade.
The list of restricted stocks:
https://www.tdameritrade.com/retail-en_us/resources/pdf/cesecuritylist.pdf
GLTA,
Farrell
I have received a similar email from TD Ameritrade. Fortunately IPIX is not on the exclusion "{Caveat Emptor"}list:
"The U.S. Securities and Exchange Commission ("SEC) recently approved amendments to rules regarding investor protections when trading in Over the Counter ("OTC") securities. One potential impact of these rule changes is that when current information regarding issuers' financials is not available, and/or quotations are also unavailable, such securities may be designated as Caveat Emptor ("buyer beware"). These changes have the potential to create conditions where the security is difficult to sell or trade.
Effective May 25, 2021, TD Ameritrade will restrict orders in Caveat Emptor-designated securities to liquidation only. Only closing orders will be accepted after this time and existing orders to open new positions will be canceled..."
GLTA,
Farrell
Section 1.17 and 1.66 seems to secure IPIX rights to any manipulation of the final product. My interpretation is IPIX's rights {including the royality} are secure as long as the final compound contains patented Brilacidin.
1.17 “Compound” means IPI’s proprietary molecule known as Brilacidin in the chemical structure set forth in Exhibit B, including any back-up compounds and analogues (including, prodrugs, metabolites, complexes, degradants, impurities, mixtures and other combinations) their salts, solvates, hydrates, stereoisomers, crystalline and amorphous forms, owned or Controlled by IPI as of the Effective Date or during the Term.
1.66 “Product” means any pharmaceutical product using the Formulation containing the Compound (alone or in combinations with other active pharmaceutical ingredients) in the Indication.
Section 8 covers IPIX's responsibilities to maintain and enforce its patents for Brilacidin in Alfa Sigmas territory. As long as the patents are current the 6% royality applies regardless of how Alpha Sigma compounds the Brilacidn preparation.
Nothing in the document implies Alpha Sigma's royalty to IPIX will reduced for any compound that contains patented Brilacidin.
"They've apparently developed their own compound that USES Brilacidin. Might that not lower the royalty to 2%? "
GLTA Farrell
My intuition tells me Alpha Sigma want to get their trail under way because the Brilacidin oral medication trial for ulcerative colitis is projected to start soon. They could be concerned the oral formulation will work so well the rectal preparation will be superfluous.
Glta,Farrell
Why would you think Brilacidin's safety would be an issue in this trial when it has not been a significant problem in any previous trial?
Imagine your mom presents to the hospital with an oxygen level of 88; respirations 28 a minute. Her doctor just told you her Covid swab was positive. He stated a new medicine was approved for Covid 19 which has been shown to reduce mortality and complications, but it may cause transient tingling and BP elevations?
What would you do?
Genuinely keen to hear!!!
GLTA,Farrell
That's your opinion. My opinion is an antiviral which is active against Covid,even to a mild degree, will be an important part of any treatment regimen for Covid 19.Currently none of the antivirals studied against Covid19 have shown reproducible results in lowering the mortality or complications of Covid19.
It appears we will know the results of the Phase 2 trial sooner than we thought.
Then of course the risk of being long is reduced by the potential of Brilacidin being a pan viral agent, a unique treatment for inflammatory bowel disease as well as a means of reducing the pain and irritation suffered by patients receiving cis platinum and radiation for head and neck cancer.
All of the above are reasons I bought more shares yesterday.
Glta,
Farrell
First glance of 10q is terrific. Progress on IBD and Covid19 affirms the reasons I continue to invest in IPIX.
I bought shares yesterday.
Busy all day today. Will deep dissect 10 Q later
GLTA Farrell
Terrific post. Its good to return to reality.
Good luck,
Farrell
"...make the Brilacidin a most potent drug against SARS-CoV-2 than the known antiviral drugs."
Quite a quote and in a prestigious journal, no less.
Thanks for posting\,
Farrell
"Bio-computational designed Brilacidin is a synthetic non-peptide defensin mimic drug that destabilises the viral membrane by its amphipathic & hydrophobic nature, and its immunomodulatory property influence the expression of IL-1ß, IL-6, TNF-a cytokines, and cAMP& PDE4/PDE3 pathways which are associated with bronchodilator and anti-inflammatory effects of COVID-19 disease. The smaller size, more effective antimicrobial activity, bioavailability, low enzymatic degradation and toxicity, natural and low-cost production make the Brilacidin a most potent drug against SARS-CoV-2 than the known antiviral drugs."
Good thought. The first thing that came to my mind was a statistical blip due to differences in SOC at different hospitals, but who knows.
GLTA,
Farrell
If you had been paying attention you would realize all the antiviral being tested for moderate to severely ill Covid19 patients have failed to reduce mortality or complications of Covid 19. These medications include Remdesivir, Favipiravir, Molunpiravir,Regeneron's and Lilly's monoclonal antibodies and others.
Now many of these medications are being tested in the mild Covid patients to see if they reduce the chance of progression to moderate or severe disease.
Will the Pfizer pill for Covid19 be effective when other IV protease inhibitors, lopinavir and ritonavir, have completely failed?
Brilacidin is being tested for the as a Covid 19 antiviral for the moderate to severe disease patients. If it is successful it will have virtually no competition. Most moderately to severely ill patients ideally should have a antiviral as a part of their therapeutic regimen.
As you should know Brilacidin has advantages over all the antivirals studied to date. It is the only virucidal antiviral. It begins killing Covid in the serum, extracellular space and inside the cells on contact. Its is active immediately where many of the other drugs such as Remdesivir have to be converted to an active form inside the cells. It is the only well documented anti-inflammatory antiviral. Brilacidin may possess a triple antiviral mechanism of action. It shreds the viral capsid, prevents viral cellular attachment and may be active against the main protease to prevent viral reproduction. It is a broad spectrum antibiotic with activity against most Gram positive bacteria including MRSA as well as some gram negative bacteria which will reduce the chance of secondary infections such as pneumonia and septicemia in these ill patients.
It should be obvious that the vaccines are never going to be 100% effective, Covid mutates frquently reducing the effectiveness of the vaccines and millions of individuals will never take the vaccines.
It is also obvious Covid19 with its deaths and side effects is not going away even with vaccines and preventative treatments.
Unfortunately a market for an effective Covid19 antiviral is going to be needed because death and morbidity from Covid is going to be with us .
GLTA Farrell
The best known protease inhibitors for Covid19 are Lopinavir and Ritonavir they failed a well done clinical trial for Covid19. Most approved protease inhibitors are used for AIDS.
"In patients admitted to hospital with COVID-19, lopinavir–ritonavir was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death. These findings do not support the use of lopinavir–ritonavir for treatment of patients admitted to hospital with COVID-19."
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32013-4/fulltext
GLTA Farrell
I agree. I look for more help if the Phase2 trial produces positive results.
Grants, partnership offers, expedited trials, EUA or at least expanded compassionate use. I hope we can do something for India soon.
Just a few weeks away.
GLTA,Farrell
News 50% enrollment achieved.
GLTA,Farrell
Thanks for posting. I missed that nugget in the 10q.
Of course more benefits for the BOD means more responsibility and time.
What could that mean?
GLTA,
Farrell
So far the "India connection" brings up more questions than answers.
I could speculate all day , but if you know something now is the time to come clean.
Help us out.
GLTA,Farrell
Many individuals across the country are concerned about the side effects of the vaccines and the economic effects of mitigation. Are you stating Michigan is more concerned than other states? My guess is vaccine rates in Michigan will be in the middle of the other states in vaccine rates. We will see if any one can dig out up to date
state statistics.
Glta, Farrell
I believe Brilacidin will be given for Covid under the FDA expanded compassionate use plan if the phase 2 is only mildly positive. Early in the epidemic last spring Remdesivir was given to many patients who failed standard treatments under the same program.
Glta,
Farrell
Good point. Michigan was one of the most restrictive states for mitigation and closings. Now they are suffering a recurrence of Covid now that the variants/mutations are spreading.
Glta Farrell
Brilacidin for Oral Mucositis
"Summary of Topline Results from the Placebo-Controlled Phase 2 Trial
· Brilacidin met primary endpoint of reduced incidence of severe OM experienced by patients during radiation therapy.
· Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
· Incidence of severe OM in Per Protocol (PP) Population: Brilacidin 36.8%, Placebo 60.0%.
· Trial results support continued and expedited development of Brilacidin-OM."
"None of the SAEs were classified by the Investigator as related to Brilacidin."
http://www.ipharminc.com/press-release/2017/12/11/innovation-pharmaceuticals-reports-positive-topline-results-from-phase-2-placebo-controlled-trial-of-brilacidin-for-the-prevention-of-oral-mucositis-in-head-and-neck-cancer-patients
Comparative graph of Brilacidin for oral mucositis:
http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositis-at-a-glance-comparative-data-presentation-with-other-investigational-om-drugs
Many of the reported SAEs and AEs are a result of 1 Oral Mucositis 2 Radiation 3 Chemotherapy and 4 the head and neck cancer 5 the patients underlying medical disorders
Some of the reported AE an SAE's in both the treated and placebo group include Radiation skin damage, White cell decrease, febrile neutropenia, catheter site cellulitis, atrial fib, embolism and a variety of oral complaints consistent with oral mucositis.
When you review the AE and SAE's critically few can be blamed on the Brilacidin Sachets.
These are extremely ill patients receiving toxic chemotherapy and radiation which results in debilitating ulceration and irritation of the oral cavity which makes it difficult to eat or swallow to the point where they can not maintain their hydration,weight or continue their treatments. Many require gastric tubes for survival.
GLTA,
Farrell
The Sputnik vaccine is still generating controversy. Link below summarizes some of the concerns which may prove to be minor. Apparently it is the same viral vector technology used by Johnson and Johnson and AstraZenica which both have had there share of concern.
https://www.dw.com/en/is-sputnik-v-vaccine-safe/a-57219314
GLTA, Farrell
"capacity to produce... tons"
It is interesting the Chinese are interested in the manufacture of Brilacidin. The Chinese are probably already making Brilacidin in bulk,and this company wants to get in on the production of a chemical intermediary for the rest of the world which recognizes patent rights.
Thanks for posting... a very intriguing find
"We have our own industry park and our capabilities include rapid initial scale-up and custom synthesis with the capacity to produce up to tons. We supply 4,6-Pyrimidine dicarboxylic acid (CAS NO. 16490-02-1) with high quality which is an intermediate for Brilacidin."
Good luck,Farrell
The 4,6-Pyrimidine dicarboxylic acid is an intermediate compound used in the production of Brilacidin.step c below
c) adding the compound of Formula II and pyrimidine-4,6-dicarboxylic acid in presence of N-(3-dimethylaminopropyl)-N'-ethylcarbodiirnide hydrochloride pyridine to form a compound of Formula III
The biochemists in the group may find it easier to follow process of assembly with the graphs listed in the link to the patent. Preceding this in the patent is a detailed outline of the immunologic properties of Brilacidin which has not been published.
GLTA,
Farrell
https://patents.google.com/patent/WO2016133733A1/en
DETAILED DESCRIPTION OF THE INVENTION
The starting materials, which are required to prepare the compound brilacidin and the pharmaceutically acceptable salts thereof, are commercially available in bulk. The compound brilacidin and the salts are prepared by
a) reacting (R)-(-)-N-Boc-3-pyrrolidinol with 2-chloro-5-(trifluoromethyl)-l ,3- dinitrobenzene in the presence of potassium ter-butoxide to form a compound having Formula I
Figure imgf000012_0001
I;
b) reacting the compound of Formula I with an alcohol and a transition metal catalyst in the presence of hydrogen to form a com ound of Formula II
Figure imgf000012_0002
?;
c) adding the compound of Formula II and pyrimidine-4,6-dicarboxylic acid in presence of N-(3-dimethylaminopropyl)-N'-ethylcarbodiirnide hydrochloride pyridine to form a compound of Formula III
Figure imgf000012_0003
in;
d) reacting the compound of Formula III with 5-(carbobenzoxyamino)valeric acid to form a compound of Formula IV
Figure imgf000012_0004
e) reducing the resultant compound of formula IV in the presence of an alcohol, a transition metal catalyst, and hydrogen to afford formula V
Figure imgf000013_0001
V;
f) reacting the resultant compound of V with di-N-Boc pyrazole in the presence of base to provide compound of formula VI ;
Figure imgf000013_0002
VI; and
deprotecting the compound of Formula VI using acid to produce PMX-30063 (brilacidin); and, if desired, preparing a pharmaceutically acceptable salt.
Brilacidin's competition is continuing to fade. An antiviral against Covid 19 is a needed part of any treatment regimen.
Brilacidin may prove to be the best hope for moderate to severe Covid19.
Hopefully we can receive some help to push this trial through.
GLTA Farrell
Ridgeback and Merck halt molnupiravir trial for Covid 19 hospitalized patients.
In addition to announcing the withdrawal of its vaccine and CD24Fc, Merck has also announced Ridgeback and Merck are halting Covid 19 trials for hospitalized patients with oral molnupiravir.
"Early study results on hospitalized patients found that the treatment is unlikely to reduce hospitalization stays and deaths, the companies said Thursday.
Merck said testing found that the drug, called molnupiravir, inhibits replication of the virus. But the trial of people who weren’t hospitalized was too small to show that the drug reduced clinical symptoms during their early treatment, Merck said.
Another surprise Merck announcement today reverses previous optimistic reports of molnupiravirs results for Covid19.
Brilacidin's competitors are dropping like flies.
Farrell
https://www.wsj.com/articles/merck-partner-halt-covid-19-treatment-trial-for-hospitalized-patients-11618483561
You never know, maybe Merck has had a heart to heart talk with Leo about Brilacidin and decided to send up the white flag.
Wouldn't that be something!
Farrell
It is a stunning turn. Merck after spending over 425 million dollars to acquire CD24Fc, it was pressing the FDA for approval a few weeks ago.
https://www.merck.com/news/merck-to-acquire-oncoimmune/
Its initial FDA application was met with skepticism as the FDA ask for more information to answer questions regarding its apparent outstanding initial FDA trials.
https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back
Merck had even reach an agreement with the FDA to manufacture the drug.
https://www.merck.com/news/merck-announces-supply-agreement-with-u-s-government-for-initial-doses-of-investigational-biological-therapy-for-the-treatment-of-patients-with-severe-and-critical-covid-19/
Now they have withdrawn the drug. Wow how quickly things turn.
http://wearegeneralnews.com/merck-ends-development-of-covid-drug-it-acquired-from-oncoimmune/
GLTA Frrell
It is really not a fair question:
"There was no suggestion at all in the October release announcement of a "planned interim analysis" that the review to be conducted would be limited to safety or that it would be for the purpose of determining whether the initial dosage regimen could be extended. None. So I thought it a fair question."
You know as well as anyone the October PR was before the FDA review. The FDA guided the protocol for the phase 2 Brilacidin study fo Covid19.
Pretending the company some how misguided shareholders is misleading... at best.
Good day,
Farrell
Linked below is a whistle blower lawsuit which claims the CDC, NIAID, and Dr Fauci illegally exchanged data with the Wuhan lab and others including Moderna.
The suit outlines in great detail the irregularities in the relationship between Wuhan, North Carolina, NIAID and Dr Fauci
https://f.hubspotusercontent10.net/hubfs/8079569/The%20FauciCOVID-19%20Dossier.pdf
https://www.linkedin.com/pulse/evidence-towards-antitrust-lawsuit-against-cdc-fauci-et-lehrman/
Another report from 2016 of the North Carolina lab producing a virus similar to COVID 19 with the heads of the Wuhan Lab ( Zhengli-Li Shi} and Noth Carolina lab (Ralph Baric} as co authors.
https://www.nature.com/articles/nm.3985
" Using the SARS-CoV reverse genetics system2, we generated and characterized a chimeric virus expressing the spike of bat coronavirus SHC014 in a mouse-adapted SARS-CoV backbone. The results indicate that group 2b viruses encoding the SHC014 spike in a wild-type backbone can efficiently use multiple orthologs of the SARS receptor human angiotensin converting enzyme II (ACE2), replicate efficiently in primary human airway cells and achieve in vitro titers equivalent to epidemic strains of SARS-CoV. Additionally, in vivo experiments demonstrate replication of the chimeric virus in mouse lung with notable pathogenesis."
Farrell
Dr Ralph Baric is a professor at the University of North Carolina. He has been described as a leading expert in coronavirus research.
https://sph.unc.edu/adv_profile/ralph-s-baric-phd/
He has been criticized for performing "gain of function" experiments on cornavirus where the viral genome is manipulated to add additional "function".
https://www.wral.com/coronavirus/controversial-virus-research-seen-both-as-groundbreaking-reckless/19098107/
https://www.nature.com/news/engineered-bat-virus-stirs-debate-over-risky-research-%201.18787
https://www.the-scientist.com/news-opinion/lab-made-coronavirus-triggers-debate-34502
Below is a report of some of his research describing the gain in function by genetic manipulation of Coronvirus and attempts to study vaccines against the lab created viruses.
https://www.med.unc.edu/orfeome/wp-content/uploads/sites/609/2018/03/a-sars-like-cluster-of-circulating-bat-coronaviruses-shows-potential-for-human-emergence.pdf
"We report the in vitro reconstruction and biological character-ization, using reverse genetics and synthetic-genome design, of aninfectious clone of BtCoV HKU5 (icBtCoV HKU5) containing theectodomain from the SARS spike (S) protein (BtCoV HKU5-SE).We show that BtCoV HKU5-SE replicated efficiently and demon-strate that a small molecule inhibitor targeting 3CLpro effectivelyinhibited BtCoV HKU5-SE and MERS-CoV replication in cellculture. In addition, we report that BtCoV HKU5-SE replicated tohigh titers in both young and aged mice but did not cause life-threatening disease. Virus replication and disease were dependenton the presence of the mouse angiotensin-converting enzyme 2(ACE2) receptor, and immunohistochemistry staining demon-strated the presence of viral antigen in epithelial cells lining thesmall airways and alveoli."
The risky research was stopped temporarily in 2014:
https://www.npr.org/sections/health-shots/2014/11/07/361219361/how-a-tilt-toward-safety-stopped-a-scientists-virus-research
The NIH may have provided funding for the Wuhan lab:
https://thediplomat.com/2020/05/why-would-the-us-have-funded-the-controversial-wuhan-lab/
There is speculation that cooperation between the North Carolina labs and the Wuhan labs led to the final development of Covid 19.
The government denies these claims and others that Dr Fauci assisted the cooperation between the American and Chinese labs.They also state the Covid19 virus occurred naturally without genetic manipulation.
https://www.statesman.com/story/news/politics/politifact/2021/02/09/covid-dr-anthony-fauci-did-not-fund-research-tied-creation/4450338001/
GLTA,Farrell
Please sticky at top. Post of the month if not the year.Thanks for posting.
Good luck to all,
Farrell
Aarthi Narayanan1 was the lead researcher and author for the first Brilacidin publication in, Viruses.
Dr Narayanan should be well known to her peers as she has dozens of publications related to viral research including several for Covid19 and Alpha viruses. My guess is she would be invited to make the Brilacidin presentation at the conference.
https://scholar.google.com/scholar?start=30&q=%22Aarthi+Narayanan%22&hl=en&as_sdt=0,18
Your negativity is unwarranted. The presentation will publicize Brilacidin to some of the leading virologists in the world at a time where viral research has been the focus of the scientific, government and medical communities.
The press will cover this conference with great interest for any reports of possible therapeutic treatments for Covid19.
The presentation is an acknowledgement of Brilacidin's activity against Covid19 and it is a big deal.
GLTA,
Farrell
I agree, but I doubt Remdesivir will be part of the protocol. My guess is we will see a step wise protocol in the patients with significant but early pulmonary involvement.Hopefully Brilacidin will prove to be the antiviral of choice with Dexamethasone and anti coagulants added as the disease progresses.
So far the many other anti-inflammatories and antivirals seem to be only weakly effective, but they may prove to be effective in subsets of the very ill patients. eg leronlimab, tocilizumab etc
Merck and Oncoimmune's GVH drug, CD24Fc, had impressive results , but the FDA is requiring additional testing. Dexamethasone is going to be difficult to replace.
The treatment regimen needs an effective antiviral. A combination of antivirals with different complementary mechanisms of action may be necessary, but Brilacidin is the only virucidal, anti-capsid drug being studied and it may have 2 other antiviral MOA's plus the anti-inflammatory and antibiotic properties.
We should know more soon as the Phase 2 Brilacidin study is reported.
https://www.fiercebiotech.com/biotech/fda-tells-merck-told-to-show-more-data-for-its-oncoimmune-covid-drug-as-eua-pushed-back
GLTA, Farrell
Variants continue to spread in the US accounting for 27% of new cases. New variant outbreaks now in Michigan and Florida.
Brilacidin seems to be needed now more than ever.
GLTA,
Farrell
From the NYT 4/3
https://www.nytimes.com/2021/04/03/health/coronavirus-variants-vaccines.html?action=click&module=RelatedLinks&pgtype=Article&action=click&module=RelatedLinks&pgtype=Article
"Even as vaccines were authorized late last year, illuminating a path to the pandemic’s end, variants were trouncing Britain, South Africa and Brazil. New variants have continued to pop up — in California one week, in New York and Oregon the next. As they take root, these new versions of the coronavirus threaten to postpone an end to the pandemic.
At the moment, most vaccines appear to be effective against the variants. But public health officials are deeply worried that future iterations of the virus may be more resistant to the immune response, requiring Americans to queue up for regular rounds of booster shots or even new vaccines..."
"“We don’t have evolution on our side,” said Devi Sridhar, a professor of public health at the University of Edinburgh in Scotland. “This pathogen seems to always be changing in a way that makes it harder for us to suppress.”
"Health officials acknowledge an urgent need to track these new viruses as they crawl across the United States. Already, B.1.1.7, the highly contagious variant that walloped Britain and is wreaking havoc in continental Europe, is rising exponentially in the United States.
Limited genetic testing has turned up more than 12,500 cases, many in Florida and Michigan. As of March 13, the variant accounted for about 27 percent of new cases nationwide, up from just 1 percent in early February."
“We didn’t quite anticipate how quickly it was going to occur.”
"A variant is of concern only if it is more contagious, causes more severe disease, or blunts the immune response. The variants identified in Britain, South Africa, Brazil and California all fit the criteria.
B.1.1.7, the first to come to widespread attention, is about 60 percent more contagious and 67 percent more deadly than the original form of the virus, according to the most recent estimates.
The variant is no different from the original in how it spreads, but infected people seem to carry more of the virus and for longer, said Katrina Lythgoe, an evolutionary biologist at the University of Oxford. “You’re more infectious for more days,” she said.
So contagious is B.1.1.7 that Britain succeeded in driving down infections only after nearly three months of strict stay-at-home orders, plus an aggressive vaccination program. Even so, cases fell much more slowly than they did during a similar lockdown in March and April."
Poland’s rate of daily new cases has quintupled since mid-February, forcing the closure of most public venues. Germany’s has doubled, triggering a ban on nighttime gatherings in Berlin.
In France, where B.1.1.7 is causing three-quarters of new infections, some hospitals have had to move coronavirus patients to Belgium to free up beds. Roughly as many people are dying each day from Covid-19 in Europe as were this time a year ago.
For too long, government officials disregarded the threat. “Case plateaus can hide the emergence of new variants,” said Carl Pearson, a research fellow at the London School of Hygiene and Tropical Medicine. “And the higher those plateaus are, the worse the problem is.”
In the United States, coronavirus infections began a rapid decline in January, soon prompting many state leaders to reopen businesses and ease restrictions. But scientists repeatedly warned that the drop would not last. After the rate bottomed out at about 55,000 cases and 1,500 deaths per day in mid-March, some states — notably Michigan — began seeing an uptick.
Since then, the national numbers have steadily risen. As of Saturday, the daily count was up to nearly 69,000, and the weekly average was 19 percent higher than the figure two weeks earlier.
Even when cases were falling, researchers questioned the notion that vaccinations were the reason. Millions of Americans are immunized every day, but even now only 31 percent have received a single dose of a vaccine, and just 17 percent of the population have full protection, leaving a vast majority susceptible.
“The fact is that we’re still in a position now where we don’t have enough vaccinated people,” said Kristian Andersen, a virologist at the Scripps Research in San Diego. “And if we, like Texas, say we’re done with Covid-19, B.1.1.7 will come in and remind us that we are not right. I have no doubt about it.”
“I still don’t think we’re out of the woods,” Dr. Cobey said, referring to the country at large. “If we don’t have another wave this spring, then I’m going to be really, really worried about the fall.”
"While most vaccines are effective against B.1.1.7, researchers are increasingly concerned about other variants that contain a mutation called E484K. (Scientists often refer to it, appropriately, as “Eek.”)
This mutation has evolved independently in many variants worldwide, suggesting that it offers the virus a powerful survival advantage.
In laboratory studies, the Pfizer-BioNTech and Moderna vaccines seem to be slightly less effective against B.1.351, the variant identified in South Africa. That variant contains the Eek mutation, which seems to enable the virus to partly sidestep the body’s immune response. The vaccines made by Johnson & Johnson, AstraZeneca and Novavax were even less potent against B.1.351.
“I think for the next year or two, E484K will be the most concerning” mutation, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Research Center in Seattle.
The mutation slightly alters the so-called spike protein sitting on the surface of the coronavirus, making it just a bit harder for antibodies to latch on and destroy the invader.
The good news is that the virus seems to have just a few survival tricks in its bag, and that makes it easier for scientists to find and block those defenses. “I’m feeling pretty good about the fact that there aren’t that many choices,” said Michel Nussenzweig, an immunologist at Rockefeller University in New York.
The Eek mutation seems to be the virus’s primary defense against the immune system. Researchers in South Africa recently reported that a new vaccine directed against B.1.351 ought to fend off all other variants, as well.
Pfizer, BioNTech and Moderna already are testing newly designed booster shots against B.1.351 that should work against any variants known to blunt the immune response.
Instead of a new vaccine against variants, however, it may be just as effective for Americans to receive a third dose of the Pfizer-BioNtech or Moderna vaccines in six months to a year, said Dr. Anthony S. Fauci, head of the National Institute of Allergy and Infectious disease."
Thanks for posting. My guess is a PR will be coming soon. Perhaps an interim report and update.
GLTA,
Farrell
Great video which I will share with my friends.
GLTA,
Farrell
Thanks for putting the SRO designation in context.
Here is more. Evidently the FDA expects IPIX may have pharmaceutical sales, a regulated product, or operations in fields regulated by the FDA.
"HHS Supplemental Standards of Ethical Conduct formally defines SRO as “an organization for which the sales of products regulated by the Food and Drug Administration (FDA) constitute ten percent or more of annual gross sales in the organization's previous fiscal year; where an organization does not have a record of sales of FDA-regulated products, it will be deemed to be significantly regulated if its operations are predominately in fields regulated by FDA, or if its research, development, or other business activities are reasonably expected to result in the development of products that are regulated by FDA." See 5 C.F.R. § 5501.101(c)(2)."
Another step along the path. The FDA ia aware of Brilacidin for Covid19 and is watching its clinical trial and development.
GLTA,
Farrell
https://www.fda.gov/about-fda/ethics/significantly-regulated-organizations-sros