Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one.
Emergency Ends – First, the Biden Administration announced that it would be allowing the Public Health Emergency (PHE) declaration to lapse this coming May. In a separate (and pointless) development, the U.S. House of Representatives voted to end the declaration – theater-legislation given that the initiative would never be passed into law and the policy decision was already made. The PHE, initiated during the prior Administration and extended repeatedly by the current Administration, put into place a number of policy initiatives in relation to the COVID-19 response, most significantly initiatives that enhanced the ability freer access for people to get vaccines, medicines and testing. With the end of the PHE declaration, access for individuals will shift away from government support and rely on a person’s insured status (either public or private) and any state policies in effect.
- Impact on EUAs? One aspect largely missed in the media reporting on the PHE conclusion is in regard to whether or not the action has an impact on the Emergency Use Authorization (EUA) status conferred by FDA on a number of vaccines, diagnostic tests, and medicines during the COVID emergency. However, the PHE that will end on May 11 is distinct from the separate from the mechanism that allows FDA to issue EUAs for medical products. Therefore the status of those medical products that have EUAs will not be affected by the ending of the PHE, declared under the auspices of the Public Health Service Act. The emergency declaration that confers the ability of FDA to issue EUAs is a separate regulatory mechanism and is part of the Federal Food and Drug Cosmetic Act. FDA has stated in an updated FAQ on the topic that any change that would impact EUAs would first be published in the Federal Register with ample time provided for transition of products from EUA status.
Face-to-Face Meetings – On a separate note, it was reported this week that FDA will be engineering an eventual return to in-person meetings with industry. FDA has provided an update on the website regarding Face-to-Face (FTF) meetings with staff transitioning in 2023 to return, at least part of the time, to the FDA campus.
- Impact on AdComms? While it is almost impossible to think of that absolutely HUGE campus empty all this time, the return naturally raises the important question as to how this change will impact industry, with specific attention to FDA Advisory Committee meetings. In a prior post, it was noted (without making a causative connection) that since meetings went virtual, they have also gone more negative, with a higher rate of “no votes” than in prior years. In the communication regarding the transition, FDA has stated that they will be re-fitting conference rooms with some fancy new equipment – face/conversation tracking cameras and boom forming microphones for example – and the agency will have in-person participation likely limited to those with speaking roles, while others will be relegated to a virtual presence. Hence, a hybrid meeting. Because the number of rooms will be limited, but growing over time, these types of meetings will seemingly start out few and expand as re-fitted facilities come on line. The agency is targeting smaller industry meetings for this effort. Sadly, no mention yet of FTF AdComms.
It would appear that we are emerging, in some respects, glacially from the COVID era. As noted in the previous posting, FDA is talking less about the pandemic than before. And while it is good to have this in the rear view mirror, it is worth noting that daily mortality is still high, people are still hospitalized at a high rate, and many people are still getting sick with it for the first time. We are moving on, but the pandemic is still very much with us.cdc emergency use authorization house of representatives pandemic covid-19 testing fda mortality
Tesla rival Polestar reveals lineup of its new electric vehicles
The Sweden-based electric vehicle maker completes key testing before launching production of its new SUV.
Tesla's Model Y crossover, the best-selling vehicle globally, is the standard that electric vehicle makers strive to compete with. The Austin, Texas, automaker sold about 267,200 Model Y vehicles in the first three months of the year and continued leading the pack well into the second quarter.
It's no wonder that the Model Y is leading all vehicles in sales as it retails for about $39,390 after tax credits and estimated gas savings. Ford (F) - Get Free Report hopes to compete with the Model Y about a year from now when it rolls out the new Ford Explorer SUV that is expected to start at $49,150.
Plenty of competition in electric SUV space
Mercedes-Benz (MBG) however, has a Tesla rival model with its EQB all-electric compact sports utility vehicle with an estimated 245 mile range on a charge with 70.5 kWh battery capacity, 0-60 mph acceleration in 8 seconds and the lowest price of its EVs at a $52,750 manufacturers suggested retail price.
Tesla's Model X SUV has a starting price of about $88,490, while the Model X full-size SUV starts at $98,490 with a range of 348 miles. BMW's (BMWYY) - Get Free Report xDrive50 SUV has a starting price of about $87,000, a range up to 311 miles and accelerates 0-60 miles per hour in 4.4 seconds.
Polestar (PSNY) - Get Free Report plans to have a lineup of five EVs by 2026. The latest model that will begin production in the first quarter of 2024 is the Polestar 3 electric SUV, which is completing its development. The vehicle just finished two weeks of testing in extreme hot weather of up to 122 degrees in the desert of the United Arab Emirates to fine tune its climate system. The testing was completed in urban cities and the deserts around Dubai and Abu Dhabi.
“The Polestar 3 development and testing program is progressing well, and I expect production to start in Q1 2024. Polestar 3 is at the start of its journey and customers can now visit our retail locations around the world to see its great proportions and sit in its exclusive and innovative interior,” Polestar CEO Thomas Ingenlath said in a statement.
Polestar plans 4 new electric vehicles
Polestar 3, which will compete with Tesla's Model X, Model Y, BMW's iX xDrive50 and Mercedes-Benz, has a starting manufacturer's suggested retail price of $83,000, a range up to 300 miles and a charging time of 30 minutes. The company has further plans for the Polestar 4, an SUV coupé that will launch in phases in late 2023 and 2024, as well as a Polestar 5 electric four-door GT and a Polestar 6 electric roadster that the company says "are coming soon."
The Swedish automaker's lone all-electric model on the market today is the Polestar 2 fastback, which has a manufacturer's suggested retail price of $49,900, a range up to 320 miles and a charging time of 28 minutes. The vehicle accelerates from 0-60 miles per hour in 4.1 seconds. Polestar 2 was unveiled in 2019 and delivered in Europe in July 2020 and the U.S. in December 2020.
Polestar 1, the company's first vehicle, was a plug-in hybrid that went into production in 2019 and was discontinued in late 2021, according to the Polestar website.
The Gothenburg, Sweden, company was established in 1996 and was sold to Geely affiliate Volvo in 2015.
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Our Society Is Melting Down Even Faster Than Most People Thought That It Would
Our Society Is Melting Down Even Faster Than Most People Thought That It Would
Authored by Michael Snyder via The End of The American Dream…
It can be difficult to believe that the wild scenes that we are witnessing on the streets of America are actually real. Earlier this week, I wrote an article entitled “What Life Is Really Like In America’s Hellish Inner Cities”. I wrote that article before the widespread looting that just erupted in Philadelphia. Just when I think that conditions in our core urban areas have reached a low point, they seem to find a way to get even worse. Unfortunately, this is just the beginning of this crisis. As economic conditions continue to deteriorate, countless numbers of people will become very desperate. And when countless numbers of people become very desperate, our society will descend into a permanent state of chaos.
On Tuesday night, dozens of young people went on a rampage in the city of Philadelphia.
It is being reported that “stores in several areas of Philadelphia” were hit…
Dozens of people faced criminal charges Wednesday after a night of social media-fueled mayhem in which groups of thieves, apparently working together, smashed their way into stores in several areas of Philadelphia, stuffing plastic bags with merchandise and fleeing, authorities said.
A total of 52 arrests have been made so far, police said Wednesday.
Burglary, theft and other counts have been filed so far against at least 30 people, all but three of them adults, according to Jane Roh, spokesperson for the Philadelphia district attorney’s office.
The largest group consisted of approximately 100 young people, and there was violence when the police finally confronted that group outside of a Lululemon store…
Police in the city said that a large group of around 100 juveniles kept moving from store to store and looting them.
Videos shared on social media show officers attempting to grab thieves, some of whom are wearing Halloween masks, as they run riot through a Lululemon store.
One officer manages to hit one of the looters with a punch after tackling them to the ground.
Many on social media seem to be quite entertained by videos of the looting, but the truth is that this footage should break all of our hearts.
Everything in Center City Philadelphia is free with promo code: “the Big Guy 2024.”— Charles R Downs (@TheCharlesDowns) September 27, 2023
"Everybody keep yo phone out!"— Andy Ngô ????️???? (@MrAndyNgo) September 27, 2023
Seeking another George Floyd moment, #BLM protesters tell one another to start recording after Philadelphia Police arrived to make arrests at the downtown mass looting. Video uploaded by @OSiiNT:pic.twitter.com/oEyKU3Mhwk
Our society is literally coming apart at the seams all around us.
I had warned my readers that total retail theft would exceed 100 billion dollars this year, but now it is being reported that total retail theft already broke that threshold in 2022…
Last year, total losses tied to theft amounted to $112.1 billion, according to data from the 2023 National Retail Security Survey. That is up from $93.9 billion in losses in 2021 and $90.8 billion in 2020.
Retailers within metros including Los Angeles, San Francisco and Oakland as well as Houston, New York and Seattle were hit the hardest last year.
So if last year’s number was 112 billion, what will the final number be for 2023?
Major retail chains all over America are shutting down stores due to rampant theft.
Target Corp. will shutter nine stores across four states on Oct. 21 because of theft and threats to safety, the company announced Tuesday, the latest — and loudest —example of a retailer exiting urban locations because of crime.
Target said it made the “difficult decision” to close the stores — which include locations in the Harlem neighborhood of New York City, Seattle, Portland and the San Francisco Bay area — after the Minneapolis-based company determined that theft-preventive measures had proved ineffective. The company said it had tried adding more security, including third-party guards, and using deterrents such as locking up merchandise.
“We cannot continue operating these stores because theft and organized retail crime are threatening the safety of our team and guests and contributing to unsustainable business performance,” the company said.
But nine stores is just a drop in the bucket compared to what other retailers are doing.
For example, it is being reported that Rite Aid will close approximately 500 stores…
One of the largest U.S. drugstores chains Rite Aid is set to close around 500 stores nationwide as it negotiates a plan to file for Chapter 11 bankruptcy.
The Wall Street Journal reported that the firm, which is the third largest in the country, is looking to close branches and either sell or let creditors take over their remaining operations.
And CVS is in the process of closing a total of 900 stores by 2024…
Drugstore chain CVS is set to close hundreds of stores across the US as it undergoes a major reform to adjust to the needs of modern online shoppers.
The retail giant is coming to the end of a policy launched in 2021 which will see 300 stores closed each year – meaning 900 will have shuttered by 2024.
In the announcement, which has hit headlines again recently amid rampant shoplifting at the store, bosses they said that they were undergoing a new ‘retail footprint strategy.’
Drugstores used to be all over the place in our core urban areas.
But now our inner cities are littered with scores of boarded up establishments with “space available” signs on them.
This is what the future of America looks like, and it isn’t good.
Once upon a time, we could be proud of the shiny new cities that we had built from coast to coast.
Those cities were safe and they were clean.
But now our major cities have degenerated into crime-ridden hellholes that are absolutely filthy. In New York City, the millions of rats that live there are constantly making headlines…
This is the moment a group of horrified New Yorkers is forced to hop over scores of vermin scurrying across their path from bins outside a pizzeria.
Footage shows a few rats brazenly scurry across the pavement before scores of them emerge from an overflowing bin.
Taryn Brady, 29, who was with a group of friends when she filmed the rat encounter, said she was left in ‘fear and disgust’ after she and her friends had to hop over the rodents running towards them.
This is our country now.
I know that I keep saying that, but it is such an important point.
We don’t have the same nation that previous generations passed down to us.
Over the past 50 to 60 years, we have literally ruined America.
From the White House all the way down to the kids that are looting retailers in our major cities, we have become a laughingstock to the rest of the world.
And if we don’t find a way to turn things around, our story is going to have an absolutely tragic ending.
* * *
Fauci And The CIA: A New Explanation Emerges
Fauci And The CIA: A New Explanation Emerges
Authored by Jeffrey A. Tucker via Brownstone Institute,
Jeremy Farrar’s book from August 2021…
Jeremy Farrar’s book from August 2021 is relatively more candid than most accounts of the initial decision to lock down in the US and UK. “It’s hard to come off nocturnal calls about the possibility of a lab leak and go back to bed,” he wrote of the clandestine phone calls he was getting from January 27-31, 2020. They had already alerted the FBI and MI5.
“I’d never had trouble sleeping before, something that comes from spending a career working as a doctor in critical care and medicine. But the situation with this new virus and the dark question marks over its origins felt emotionally overwhelming. None of us knew what was going to happen but things had already escalated into an international emergency. On top of that, just a few of us – Eddie [Holmes], Kristian [Anderson], Tony [Fauci] and I – were now privy to sensitive information that, if proved to be true, might set off a whole series of events that would be far bigger than any of us. It felt as if a storm was gathering, of forces beyond anything I had experienced and over which none of us had any control.”
At that point in the trajectory of events, intelligence services on both sides of the Atlantic had been put on notice. Anthony Fauci also received confirmation that money from the National Institutes of Health had been channeled to the offending lab in Wuhan, which meant that his career was on the line. Working at a furious pace, the famed “Proximal Origin” paper was produced in record time. It concluded that there was no lab leak.
In a remarkable series of revelations this week, we’ve learned that the CIA was involved in trying to make payments to those authors (thank you whistleblower), plus it appears that Fauci made visits to the CIA’s headquarters, most likely around the same time.
Suddenly we get some possible clarity in what has otherwise been a very blurry picture. The anomaly that has heretofore cried out for explanation is how it is that Fauci changed his mind so dramatically and precisely on the merit of lockdowns for the virus. One day he was counseling calm because this was flu-like, and the next day he was drumming up awareness of the coming lockdown. That day was February 27, 2020, the same day that the New York Times joined with alarmist propaganda from its lead virus reporter Donald G. McNeil.
On February 26, Fauci was writing: “Do not let the fear of the unknown… distort your evaluation of the risk of the pandemic to you relative to the risks that you face every day… do not yield to unreasonable fear.”
The next day, February 27, Fauci wrote actress Morgan Fairchild – likely the most high-profile influencer he knew from the firmament – that “be prepared to mitigate an outbreak in this country by measures that include social distancing, teleworking, temporary closure of schools, etc.”
To be sure, twenty-plus days had passed between the time Fauci alerted intelligence and when he decided to become the voice for lockdowns. We don’t know the exact date of the meetings with the CIA. But generally until now, most of February 2020 has been a blur in terms of the timeline. Something was going on but we hadn’t known just what.
Let’s distinguish between a proximate and distal cause of the lockdowns.
The proximate cause is the fear of a lab leak and an aping of the Wuhan strategy of keeping everyone in their homes to stop the spread. They might have believed this would work, based on the legend of how SARS-1 was controlled. The CIA had dealings with Wuhan and so did Fauci. They both had an interest in denying the lab leak and stopping the spread. The WHO gave them cover.
The distal reasons are more complicated. What stands out here is the possibility of a quid pro quo. The CIA pays scientists to say there was no lab leak and otherwise instructs its kept media sources (New York Times) to call the lab leak a conspiracy theory of the far right. Every measure would be deployed to keep Fauci off the hot seat for his funding of the Wuhan lab. But this cooperation would need to come at a price. Fauci would need to participate in a real-life version of the germ games (Event 201 and Crimson Contagion).
It would be the biggest role of Fauci’s long career. He would need to throw out his principles and medical knowledge of, for example, natural immunity and standard epidemiology concerning the spread of viruses and mitigation strategies. The old pandemic playbook would need to be shredded in favor of lockdown theory as invented in 2005 and then tried in Wuhan. The WHO could be relied upon to say that this strategy worked.
Fauci would need to be on TV daily to somehow persuade Americans to give up their precious rights and liberties. This would need to go on for a long time, maybe all the way to the election, however implausible this sounds. He would need to push the vaccine for which he had already made a deal with Moderna in late January.
Above all else, he would need to convince Trump to go along. That was the hardest part. They considered Trump’s weaknesses. He was a germaphobe so that’s good. He hated Chinese imports so it was merely a matter of describing the virus this way. But he also has a well-known weakness for deferring to highly competent and articulate professional women. That’s where the highly reliable Deborah Birx comes in: Fauci would be her wingman to convince Trump to green-light the lockdowns.
What does the CIA get out of this? The vast intelligence community would have to be put in charge of the pandemic response as the rule maker, the lead agency. Its outposts such as CISA would handle labor-related issues and use its contacts in social media to curate the public mind. This would allow the intelligence community finally to crack down on information flows that had begun 20 years earlier that they had heretofore failed to manage.
The CIA would hobble and hamstring the US president, whom they hated. And importantly, there was his China problem. He had wrecked relations through his tariff wars. So far as they were concerned, this was treason because he did it all on his own. This man was completely out of control. He needed to be put in his place. To convince the president to destroy the US economy with his own hand would be the ultimate coup de grace for the CIA.
A lockdown would restart trade with China. It did in fact achieve that.
How would Fauci and the CIA convince Trump to lock down and restart trade with China? By exploiting these weaknesses and others too: his vulnerability to flattery, his desire for presidential aggrandizement, and his longing for Xi-like powers over all to turn off and then turn on a whole country. Then they would push Trump to buy the much-needed personal protective equipment from China.
They finally got their way: somewhere between March 10 or possibly as late as March 14, Trump gave the go ahead. The press conference of March 16, especially those magical 70 seconds in which Fauci read the words mandating lockdowns because Birx turned out to be too squeamish, was the great turning point. A few days later, Trump was on the phone with Xi asking for equipment.
In addition, such a lockdown would greatly please the digital tech industry, which would experience a huge boost in demand, plus large corporations like Amazon and WalMart, which would stay open as their competitors were closed. Finally, it would be a massive subsidy to pharma and especially the mRNA platform technology itself, which would enjoy the credit for ending the pandemic.
If this whole scenario is true, it means that all along Fauci was merely playing a role, a front man for much deeper interests and priorities in the CIA-led intelligence community. This broad outline makes sense of why Fauci changed his mind on lockdowns, including the timing of the change. There are still many more details to know, but these new fragments of new information take our understanding in a new and more coherent direction.
Jeffrey A. Tucker is Founder and President of the Brownstone Institute. He is also Senior Economics Columnist for Epoch Times, author of 10 books, including Liberty or Lockdown, and thousands of articles in the scholarly and popular press. He speaks widely on topics of economics, technology, social philosophy, and culture.
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