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Wednesday, November 13, 2024

CDC Planned Quarantine Camps Nationwide

 by Jeffrey Tucker via The Brownstone Institute,

No matter how bad you think Covid policies were, they were intended to be worse. 

Consider the vaccine passports alone. Six cities were locked down to include only the vaccinated in public indoor places. They were New York City, Boston, Chicago, New Orleans, Washington, D.C., and Seattle. The plan was to enforce this with a vaccine passport. It broke. Once the news leaked that the shot didn’t stop infection or transmission, the planners lost public support and the scheme collapsed. 

It was undoubtedly planned to be permanent and nationwide if not worldwide. Instead, the scheme had to be dialed back. 

Features of the CDC’s edicts did incredible damage. It imposed the rent moratorium. It decreed the ridiculous “six feet of distance” and mask mandates. It forced Plexiglas as the interface for commercial transactions. It implied that mail-in balloting must be the norm, which probably flipped the election. It delayed the reopening as long as possible. It was sadistic. 

Even with all that, worse was planned. On July 26, 2020, with the George Floyd riots having finally settled down, the CDC issued a plan for establishing nationwide quarantine camps. People were to be isolated, given only food and some cleaning supplies. They would be banned from participating in any religious services. The plan included contingencies for preventing suicide. There were no provisions made for any legal appeals or even the right to legal counsel. 

The plan’s authors were unnamed but included 26 footnotes. It was completely official. The document was only removed on about March 26, 2023. During the entire intervening time, the plan survived on the CDC’s public site with little to no public notice or controversy. 

It was called “Interim Operational Considerations for Implementing the Shielding Approach to Prevent COVID-19 Infections in Humanitarian Settings.” 

“This document presents considerations from the perspective of the U.S. Centers for Disease Control & Prevention (CDC) for implementing the shielding approach in humanitarian settings as outlined in guidance documents focused on camps, displaced populations and low-resource settings. This approach has never been documented and has raised questions and concerns among humanitarian partners who support response activities in these settings. The purpose of this document is to highlight potential implementation challenges of the shielding approach from CDC’s perspective and guide thinking around implementation in the absence of empirical data. Considerations are based on current evidence known about the transmission and severity of coronavirus disease 2019 (COVID-19) and may need to be revised as more information becomes available.”

By absence of empirical data, the meaning is: nothing like this has ever been tried. The point of the document was to map out how it could be possible and alert authorities to possible pitfalls to be avoided. 

The meaning of “shielding” is “to reduce the number of severe Covid-19 cases by limiting contact between individuals at higher risk of developing severe disease (‘high-risk’) and the general population (‘low-risk’). High-risk individuals would be temporarily relocated to safe or ‘green zones’ established at the household, neighborhood, camp/sector, or community level depending on the context and setting. They would have minimal contact with family members and other low-risk residents.”

In other words, this is what used to be concentration camps. 

Who are these people who would be rounded up? They are “older adults and people of any age who have serious underlying medical conditions.” Who determines this? Public health authorities. The purpose? The CDC explains: “physically separating high-risk individuals from the general population” allows authorities “to prioritize the use of the limited available resources.” 

This sounds a lot like condemning people to death in the name of protecting them. 

The model establishes three levels.

First is the household level.

Here high-risk people are“physically isolated from other household members.” That alone is objectionable. Elders need people to take care of them. They need love and to be surrounded by family. The CDC should never imagine that it would intervene in households to force old people into separate places. 

The model jumps from households to the “neighborhood level.

Here we have the same approach: forced separation of those deemed vulnerable. 

From there, the model jumps again to the “camp/sector level.”

Here it is different. “A group of shelters such as schools, community buildings within a camp/sector (max 50 high-risk individuals per single green zone) where high-risk individuals are physically isolated together. One entry point is used for exchange of food, supplies, etc. A meeting area is used for residents and visitors to interact while practicing physical distancing (2 meters). No movement into or outside the green zone.”

Yes, you read that correctly. The CDC is here proposing concentration camps for the sick or anyone they deem to be in danger of medically significant consequences of infection. 

Further: “to minimize external contact, each green zone should include able-bodied high-risk individuals capable of caring for residents who have disabilities or are less mobile. Otherwise, designate low-risk individuals for these tasks, preferably who have recovered from confirmed COVID-19 and are assumed to be immune.”

The plan says in passing, contradicting thousands of years of experience, “Currently, we do not know if prior infection confers immunity.” Therefore the only solution is to minimize all exposure throughout the whole population. Getting sick is criminalized. 

These camps require a “dedicated staff” to “monitor each green zone. Monitoring includes both adherence to protocols and potential adverse effects or outcomes due to isolation and stigma. It may be necessary to assign someone within the green zone, if feasible, to minimize movement in/out of green zones.”

The people housed in these camps need to have good explanations of why they are denied even basic religious freedom. The report explains:

“Proactive planning ahead of time, including strong community engagement and risk communication is needed to better understand the issues and concerns of restricting individuals from participating in communal practices because they are being shielded. Failure to do so could lead to both interpersonal and communal violence.”

Further, there must be some mechanisms to prohibit suicide:

Additional stress and worry are common during any epidemic and may be more pronounced with COVID-19 due to the novelty of the disease and increased fear of infection, increased childcare responsibilities due to school closures, and loss of livelihoods. Thus, in addition to the risk of stigmatization and feeling of isolation, this shielding approach may have an important psychological impact and may lead to significant emotional distress, exacerbate existing mental illness or contribute to anxiety, depression, helplessness, grief, substance abuse, or thoughts of suicide among those who are separated or have been left behind. Shielded individuals with concurrent severe mental health conditions should not be left alone. There must be a caregiver allocated to them to prevent further protection risks such as neglect and abuse.

The biggest risk, the document explains, is as follows: “While the shielding approach is not meant to be coercive, it may appear forced or be misunderstood in humanitarian settings.”

(It should go without saying but this “shielding” approach suggested here has nothing to do with focused protection of the Great Barrington Declaration. Focused protection specifically says: “schools and universities should be open for in-person teaching. Extracurricular activities, such as sports, should be resumed. Young low-risk adults should work normally, rather than from home. Restaurants and other businesses should open. Arts, music, sport and other cultural activities should resume. People who are more at risk may participate if they wish, while society as a whole enjoys the protection conferred upon the vulnerable by those who have built up herd immunity.”)

In four years of research, and encountering truly shocking documents and evidence of what happened in the Covid years, this one certainly ranks up at the top of the list of totalitarian schemes for pathogenic control prior to vaccination. It is quite simply mind-blowing that such a scheme could ever be contemplated. 

Who wrote it? What kind of deep institutional pathology exists that enabled this to be contemplated? The CDC has 10,600 full-time employees and contractors and a budget of $11.5 billion. In light of this report, and everything else that has gone on there for four years, both numbers should be zero. 

https://www.zerohedge.com/covid-19/cdc-planned-quarantine-camps-nationwide

Amazon to Roll Out New Option for Items $20 or Less Amid Competition From Temu, Shein

 Amazon.com is launching an new section to its app and website focused on items that cost $20 or less as the internet retailer looks to fend off rising competition from low-cost platforms Temu and Shein.

Amazon said the offering, dubbed Amazon Haul, is being introduced in beta Wednesday and will be available to customers in the U.S. Items purchased through Amazon Haul are backed by Amazon's A-to-z guarantee, which covers buyers for purchases in its store that are sold by the company or a selling partner.

The Seattle company said all items would be priced at $20 or less with the majority around $10 or under. Purchases over $3 would be eligible for free returns within 15 days of delivery, a slight difference from its return policy under an Amazon Prime membership.

"Amazon Haul aims to help make shopping for fashion, home, lifestyle, electronics, and other products even more fun, easy, and affordable," said Dharmesh Mehta, Amazon's vice president of Worldwide Selling Partner Services. He added that the service would be refined as customers provide feedback.

The offering hews closely to a report from The Wall Street Journal in June that said the company planned to launch a service on shipping cheap fashion wear, household goods and other products directly from warehouses in China.

Amazon's foray into a service focused on cheaper goods will help as it competes against bargain app Temu, owned by China's PDD Holdings, and fast-fashion retailer Shein. Quick deliveries and easy returns have been a staple of Amazon's strategy, while Temu and Shein have drawn customers with low prices.

https://www.morningstar.com/news/dow-jones/2024111310520/amazon-to-roll-out-new-option-for-items-20-or-less-amid-competition-from-temu-shein

5 Reasons Biogen’s Shares Have Dropped 36% in 2024

 

A slow launch for Alzheimer’s medicine Leqembi, a lackluster pipeline and a challenging drug launch environment are just a few of the factors that have sent Biogen’s shares down this year.

Although it launched the first disease-modifying Alzheimer’s drug ever, Biogen’s shares have not reflected the monumental scientific achievement over the past year. The stock has fallen by more than one-third since hitting a high of $267 in early January, reflecting investors’ worries over the company’s future. The stock opened at $171 on Tuesday.

While Leqembi is making some headway, the launch has been slow and competition has entered by way of Eli Lilly’s Kisunla. Biogen has a few tricks up its sleeve for future pipeline options, particularly much-discussed Alzheimer’s follow-up BIIB080, but overall, investors are taking a cautious approach.

“Biogen remains a contrarian stock as investors are skeptical on Alzheimer’s and the pipeline,” Stifel’s analysts wrote in the aftermath of Biogen’s third quarter earnings call on October 30.

But many analysts including Stifel are recommending that now is a good time to buy Biogen’s stock, urging investors to look at the “big picture.”

Below, we take a look at five major drags on Biogen’s share price.

Leqembi Headwinds

While the world has been eagerly awaiting a new option for Alzheimer’s, Leqembi revenue has continued to be lower than expected as Biogen works to sustain the product’s launch. The drug brought in $67 million for the third quarter, including $39 million in the U.S.

The company told investors that it’s not a matter of demand, but healthcare systems simply haven’t adapted. Patients are not receiving the PET scans needed to begin treatment and the infusion time can be burdernsome.

Biogen is expecting sales to continue growing quarter-over-quarter and is trying to move the needle faster with plans for a subcutaneous formulation, while wider use of blood-based diagnostics could help alleviate the need for the invasive PET scans. The company also just boosted its sales force into the market, with new boots on the ground starting September 1.

While Leqembi is making sales, it’s still costing Biogen and partner Eisai a pretty penny to support the launch. Expenses related to the drug were $242.3 million for the partners—a number that eclipses global sales.

The drug is still not approved in Europe after regulators there rejected it. It’s expected to be re-examined next year.

Looking even further into the future, Biogen is testing Leqembi in a Phase III trial called AHEAD 3-45 to prevent or delay Alzheimer’s in patients who are preclinical or asymptomatic. Enrollment finished up in October with 1,400 patients. That could significantly expand the patient population.

Biogen also now has Eli Lilly to contend with after its rival Alzheimer’s drug Kisunla was approved earlier this year. But William Blair analysts suggested that the entry of a second amyloid-busting medicine could actually be a net benefit. Leqembi could differentiate because of its reduced incidences of amyloid-related imaging abnormalities (ARIA), a key safety concern that can suggest bleeding in the brain.

“From a stock perspective, we acknowledge the launch will continue to be a ‘show me’ story and tough to get ahead of (the same could be said for the stock); however, given Biogen’s valuation, we continue to see upside from growth in the Alzheimer’s franchise,” William Blair wrote.

Pipeline

Analysts have been mostly unimpressed by Biogen’s early pipeline, pushing for more business development to bring additional assets into the queue.

But Jefferies noted a few recent glimmers of hope from felzartamab, a drug acquired in the HI-Bio transaction, in the chronic kidney disease IgA nephropathy (IgAN). The company presented Phase II data at the end of October confirming stable kidney function and sustained treatment effects more than 18 months after the final dose. Biogen will expand felzartamab into Phase III trials in IgAN, antibody-mediated kidney transplant rejection and primary membranous nephropathy next year.

UCB-partnered dapirolizumab pegol is also moving into a second Phase III test after achieving the main goal of a late stage trial in systemic lupus erythematosus (SLE). The drug demonstrated clinical improvement in patients with moderate to severe disease in the Phase III trial PHOENYCS GO. The clinical program will now expand with the second study to address patients with unmet needs in SLE.

“While both are positive developments in the big picture, data is far away and both have low expectations but could surprise to the upside if positive,” Jefferies wrote of felzartamab and dapirolizumab pegol.

Biogen also has a deep Alzheimer’s pipeline, particularly BIIB080, which is tackling tau pathology in a Phase II trial. Enrollment is completed but data is not expected until 2026.

William Blair noted that executives have pegged the pipeline as having potential for $14 billion in peak revenue.

Launching Into the Unknown

It’s not just Alzheimer’s where Biogen is paving new ground. Truist Securities noted that new products Qalsody for ALS, Skyclarys in Friedreich’s ataxia (FA) and Zurzuvae in postpartum depression are all Biogen drugs with recent approvals in indications where there’s little precedent.

“Biogen is building a market in each case where there wasn’t previously existing infrastructure,” Truist wrote. That’s a tough haul for any company, even one the size of Biogen.

But if anyone can do it, it’s Biogen. BMO Capital Markets said, “Biogen has developed significant prowess in commercially executing on its rare disease portfolio.” This includes Spinraza for spinal muscular atrophy and Skyclarys for FA, and to a lesser extent Qalsody for ALS. Biogen is likely to reap the benefits of these programs eventually, but investors need to be patient, anaylsts warned.

“Revenues in 3Q24 highlighted how growth from these assets is not likely to be overnight and additional business development may be required to drive more robust topline expansion,” BMO Capital Markets wrote.

Spinraza sales dropped $67 million to $381 million for the third quarter, which Biogen attributed to the loss of an annual tender in Russia. The drug has also suffered due to competition from Novartis’ gene therapy Zolgensma. Biogen is hoping that Spinraza can return to growth, potentially in combination with Zolgensma. Other emerging competitors include Genentech’s oral treatment Evrysdi.

“There’s a lot of patients that are returning back to SPINRAZA once they’ve switched away to a competitor, and they realize that maybe the efficacy isn’t there,” said Biogen’s Alisha Alaimo, head and president of North America.

Multiple Sclerosis Franchise

Though the company was long known for its multiple sclerosis franchise, this portion of the business has been in decline for several quarters as Biogen heads for a steep patent cliff. The portfolio declined 9% to $1.05 billion in the third quarter because of “competitive dynamics,” according to CFO Mike McDonnell. A patent for Tecfidera is set to expire in February 2028. Tysabri has seen biosimilar entrants in Europe; the same has not happened yet in the U.S., but competition is coming for these patents soon.

While this issue is not new, Biogen may need to take some major business development steps to overcome it. “While management is not a fan of buying revenue to fuel growth, this may become a more compelling option as the MS franchise continues to erode,” BMO wrote.

Deal or No Deal

With all this uncertainty, Jefferies said that investors want to see more deal activity to secure the business into the future, even though Biogen has been plenty acquisitive. It picked up Reata Pharmaceuticals for $7.3 billion in September 2023 and HI-Bio for $1.15 billion in July.

“Biogen continues to have multiple assets which could drive growth in the future (Spinraza, Skyclarys, etc.), but investors may just need to be more patient to see this robust growth, or wait for more transformative [business development] — a possibility management appears to be more and more comfortable with every quarter,” BMO Capital Markets wrote.

Biogen has said it has about $8 billion to $10 billion to spend on partnerships or acquisitions to supplement growth. CEO Chris Viehbacher has said the company is “long in neurology and neuroscience,” suggesting that deals may fall out of those traditional areas of focus. He’s also satisfied with Biogen’s immunology work, especially considering the buyout of HI-Bio for $1.15 billion earlier this year. But there remains plenty of business development opportunity in that space.

Viehbacher suggested rare disease as an area where Biogen has the ability to do more while avoiding saturated Big Pharma indications like atopic dermatitis or rheumatoid arthritis.

https://www.biospace.com/business/5-reasons-biogens-shares-have-dropped-36-in-2024

Kezar’s Autoimmune Drug Hit With Second FDA Clinical Hold in as Many Months

 

Following patient deaths in a lupus trial that led to the termination of that program, Kezar’s autoimmune candidate zetomipzomib faces a partial clinical hold barring four trial participants from continuing treatment in the open-label portion of the trial, though the trial itself will continue as planned.

Kezar Life Sciences can’t catch a break this fall with its autoimmune candidate zetomipzomib. Just over a month after the FDA issued a clinical hold on zetomipzomib in lupus, the agency has placed a partial hold on a mid-stage trial of the drug in autoimmune hepatitis, Kezar said Tuesday in its Q3 business update.

Last month, Kezar made the decision to discontinue the lupus program after four patient deaths occurred during the Phase IIb PALIZADE trial. Now, a partial clinical hold will block the remaining four patients in the double-blind treatment period (DBTP) of the Phase IIa PORTOLA trial in autoimmune hepatitis from continuing treatment with zetomipzomib by moving on to the open-label extension portion of the trial. The FDA is allowing enrolled participants to complete the 24-week DBTP and for those currently enrolled in the open-label extension to continue treatment.

“This additional precaution was added to ensure any potential placebo patients still in the DBTP not be initiated on zetomipzomib, despite the IDMC recommending the PORTOLA trial proceed as planned and no reported adverse events of interest or deaths as seen in the PALIZADE trial,” William Blair analysts wrote in an investor note Wednesday. No Grade 4 or 5 serious adverse events have been observed in PORTOLA, according to Kezar.

Kezar plans to report topline data from the PORTOLA trial in the first half of 2025. The William Blair analysts emphasized the importance of this readout. “Following discontinuation of the PALIZADE study during the quarter, there is clearly significant dependence on positive results from the PORTOLA study in the first half of 2025 to spur a reversal in share price,” they wrote.

Kezar’s shares have been on a rollercoaster ride this year, falling from a high of $10.50 per share in February to a low of $5.20 per share in September. The company was trading at $7.28 per share pre-market Wednesday.

Kezar CEO Chris Kirk said in October that the decision to discontinue the lupus program was difficult as the company had seen a favorable safety profile and clinical activity in an earlier trial called MISSION. “However, a focused development effort in AIH [autoimmune hepatitis] extends our cash runway and provides flexibility as we work to bring zetomipzomib forward as a treatment for patients living with this life-threatening disease,” Kirk said in a statement at the time.

Kezar had $148 million in cash, cash equivalents and marketable securities as of September 30.

https://www.biospace.com/fda/kezars-autoimmune-drug-hit-with-second-fda-clinical-hold-in-as-many-months

Korro update after Q3

 Korro Bio (Nasdaq: KRRO) reported its third quarter 2024 financial results and provided business updates. Significant milestones include the submission of a regulatory filing for the first-in-human clinical study of KRRO-110 for alpha-1 antitrypsin deficiency (AATD), the formation of a Clinical Advisory Board (CAB), and a partnership with Novo Nordisk to develop RNA editing therapies for cardiometabolic diseases. As of September 30, 2024, Korro's cash position was $169.1 million, providing a cash runway into the second half of 2026. R&D expenses increased to $16.0 million from $14.0 million in the same period in 2023, and G&A expenses rose to $7.3 million from $5.1 million. The net loss for the quarter was $21.0 million, compared to $18.5 million in the prior year.

https://www.stocktitan.net/news/KRRO/korro-reports-third-quarter-2024-financial-results-and-provides-fm59xgi13fh7.html

Analysts Slash Their Forecasts On Progyny Following Q3

 Progyny, Inc. 

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 reported worse-than-expected third-quarter sales results and issued FY24 revenue guidance below estimates.

Progyny reported quarterly earnings of 11 cents per share which missed the analyst consensus estimate of 13 cents per share. The company reported quarterly sales of $286.63 million which missed the analyst consensus estimate of $296.88 million.

“The utilization rate in the third quarter was consistent with the expectations we outlined in August. However, the members that began their journey utilized their benefits in a manner inconsistent with long-term patterns, taking longer to progress through their treatment and, therefore, consuming fewer treatments overall, resulting in lower-than-expected revenue and profitability this quarter,” said Pete Anevski, Chief Executive Officer of Progyny. “Even though our recent results relative to expectations have been disappointing to us, the business remains fundamentally very strong, and the success of our most recent selling season further validates our leading position in a large, growing and increasingly impactful market.”

Progyny said it sees FY24 earnings of $1.54 to $1.57 per share on revenue of $1.135 billion to $1.150 billion.

Progyny shares dipped 15.1% to trade at $14.59 on Wednesday.

These analysts made changes to their price targets on Progyny following earnings announcement.

  • Truist Securities analyst Jailendra Singh downgraded Progyny from Buy to Hold and lowered the price target from $26 to $19.
  • Canaccord Genuity analyst Richard Close maintained Progyny with a Hold and lowered the price target from $18 to $17.

Lexeo Update on Cardiac Portfolio After Q3

 Reached alignment with FDA on key elements of registrational development plan for LX2006, including accelerated approval pathway with left-ventricular mass index (LVMI) and frataxin protein expression as co-primary registrational endpoints

Received RMAT designation for LX2006 for the treatment of Friedreich ataxia (FA) cardiomyopathy, potentially enabling expedited development and increased interaction with the FDA

Completed enrollment of LX2006 SUNRISE-FA Phase 1/2 trial, with four participants treated in cohort 3; total of 16 participants dosed with LX2006 to date across SUNRISE-FA and Weill Cornell trials

Completed enrollment of cohort 1 of LX2020 HEROIC-PKP2 Phase 1/2 trial; initial clinical data including safety and biodistribution on track for late Q1 / early Q2 2025

Appointed Tolga Tanguler to Board of Directors, an accomplished biopharmaceutical executive with over 25 years of senior leadership experience

Cash and cash equivalents of $157.0 million expected to provide operational runway into 2027

Lexeo expects to provide an overview of upcoming program milestones at the JP Morgan Healthcare Conference in January 2025. Additional information on program updates is available in the latest corporate presentation on Lexeo’s website.

Upcoming Investor Conferences

  • Stifel 2024 Healthcare Conference: November 19, 2024
  • Jefferies London Healthcare Conference: November 20-21, 2024