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NextCure hires Celgene vet as CMO; José Vega leaves Merck to become Moderna’s chief safety officer

NextCure has found its new CMO after the previous executive resigned last August.
Han Myint, a biopharma and academia veteran of more than 20 years, joined the company Thursday after serving as CMO at NexImmune for a little over a year. Myint had overseen

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NextCure has found its new CMO after the previous executive resigned last August.

Han Myint, a biopharma and academia veteran of more than 20 years, joined the company Thursday after serving as CMO at NexImmune for a little over a year. Myint had overseen the company’s Phase I/II trial for a cell therapy in acute myeloid leukemia before hopping over to NextCure.

“Han’s strong industry track record is highlighted by his involvement in the development of multiple U.S. Food and Drug approved products,” CEO Michael Richman said in a statement.

At NextCure, Myint will turn his attention toward the company’s two lead programs: NC318, an immunotherapy targeting Siglec-15, and NC410, a recombinant LAIR-2 fusion protein designed to block immune suppression mediated by the immune modulator LAIR-1.

Before joining NexImmune, Myint had a senior role at Celgene, serving as VP of global medical affairs and the myeloid diseases lead for more than six years. He helped shepherd through a number of FDA-approved products during his time there, NextCure said.

Myint had previously worked at the University of Colorado-Denver between 2005 and 2012 as a professor and as the director of hematological malignancies and stem cell transplant program, building the program out.

NextCure’s former CMO Kevin Heller resigned after being named executive VP of R&D at Jasper Therapeutics last year. — Max Gelman


José Vega

Stéphane Bancel is filling out Moderna’s executive team further after the rollout of their mRNA Covid-19 vaccine, bringing in José Vega from Merck to be chief safety officer. Reporting to CMO Tal Zaks, Vega had previously been chief safety officer at Merck Research Laboratories since 2013 in what was actually his second stint with the Big Pharma — from 1997-2003, he was a director first in clinical pharmacology and then in clinical metabolism. For the 10 years in between, Vega occupied multiple roles at Amgen, the last five as VP, global safety before his Merck return.

David Lawrence

→ Just when he thought he was out, they pull him back in: David Lawrence had originally planned to retire at the end of 2020 as CFO of French vaccine biotech Valneva, but he has been re-appointed acting CFO “potentially until mid-2021,” according to a release this week. Lawrence announced his retirement in September at Valneva, which is claiming to develop the only Lyme disease vaccine in the industry and has inked a $308 million deal with Pfizer to commercialize it. In other Valneva developments, Perry Celentano — who brings experience from such pharma giants as Merck and Novartis — has joined the fray as interim COO.

→ Following this week’s surprise news that bluebird bio will divide into two companies — one for oncology, one for rare diseases — CEO Nick Leschly will take the helm on the oncology side while Sanofi Genzyme vet and Leschly’s head of Europe Andrew Obenshain will take over at bluebird bio. Leschly latches on to bluebird as executive chair, while Daniel Lynch has been chosen as chair of the new oncology company. Ramy Ibrahim, who’s been CMO at the Parker Institute for Cancer Immunotherapy, has been elected to the board of directors to add some heft in the oncology space.

Frank Neumann

→ Right when bluebird bio is undergoing this new oncology endeavor, Leschly ends up losing his head of clinical oncology research. Frank Neumann has been tapped as CMO for Brian Stuglik out at Verastem Oncology. Before his tenure at bluebird, Neumann devoted five years to Takeda, leading clinical development across their cell therapy spectrum in his final year there. He was Takeda’s global clinical lead for Iclusig (ponatinib) and medical team lead for Ninlaro (ixazomib).

Simon Pimstone

→ British Columbia neurology outfit Xenon Pharmaceuticals is getting way out in front of a change at the top, announcing that CEO Simon Pimstone will step aside and Ian Mortimer will officially take over as president and CEO at Xenon’s shareholders meeting in June. Mortimer has been CFO along with his role as president since 2018 and initially came on board back in 2013. Xenon and Neurocrine took up a collaboration to develop epilepsy drugs in December 2019, with Xenon collecting $50 million upfront.

→ Oncology, inflammation and infectious disease biotech Tiziana Life Sciences has poached Neil Graham from Regeneron, making him CMO. Graham had spent the last 10 years on Len Schleifer’s team as VP of strategic program direction, immunology and inflammation, having a hand in developing Dupixent and leading product development of Kevzara. Before his Regeneron tenure, he was SVP, program and portfolio management for Vertex.

Louis Pascarella

Louis Pascarella is taking control as CEO of Gurnet Point Capital-owned Innocoll, succeeding Rich Fante, who came on board as chief commercial officer in 2015 and rose to the top spot in March 2019. A Janssen marketing vet, Pascarella makes the move to Innocoll after three years as an exec at Novo Nordisk, culminating in his time leading US commercial operations.

James Frates

→ We now know where James Frates has landed after his time was up at Alkermes, and it’s at Amylyx as their new CFO. Joining a company focused on ALS among other neurodegenerative diseases is personal for Frates, whose late cousin Pete Frates was instrumental behind the ALS Ice Bucket Challenge. Frates had been the CFO at Alkermes since 1998 before being replaced by Iain Brown last week.

Rita Jain

→ Ex-Akebia Therapeutics CMO Rita Jain is taking on the same role at Immunovant, the autoimmune disease-focused company in Vivek Ramaswamy’s stable of Vants that boasted positive proof-of-concept data last March in its thyroid eye disease study. Before her two years at Akebia, Jain was AbbVie’s VP of men’s and women’s health and metabolic development, as well as VP, pharmaceutical development for Abbott Laboratories.

→ Backed by Frazier Healthcare Partners with one of the first IPOs of 2020, California dermatology biotech Arcutis Biotherapeutics has pegged Matthew Moore to be CBO. Moore was with Forest Laboratories, then Actavis, then Allergan after the 2015 Actavis merger, serving as Allergan’s VP, corporate business development the last four years.

Abid Ansari

→ Here’s a follow-up on Abid Ansari’s next move after deciding to step away from Precision BioSciences a month ago: He’s now the CFO at Artios Pharma, the cancer-focused biotech out of the UK backed by Pfizer and Novartis. Ansari, who had been CFO at Precision BioSciences since 2016, was involved in deal finance and portfolio management with GSK from 2011-16. And before joining the Big Pharma, he spent five years at MedImmune.

→ It didn’t take long for Bryan Laffitte to earn a promotion at San Diego RNA-focused biotech DTx Pharma. Just this past July, Laffitte took on the role of VP, biology; now he’s been bumped up to CSO. The ex-VP of biology at Inception Therapeutics, Laffitte was director of regenerative medicine for the Genomics Institute of the Novartis Research Foundation.

Eric Mosbrooker

→ Autism-focused Cognoa out of Palo Alto has brought on Eric Mosbrooker as COO. Before his move to Cognoa, which received a breakthrough designation from the FDA for its digital autism diagnostic, Mosbrooker was chief commercial officer at a beleaguered Audentes that just weeks ago saw the FDA lift a hold on its gene therapy AT132. Mosbrooker is also a Jazz Pharmaceuticals and Horizon Therapeutics alum.

→ Foster City, CA-based Mirum, which scooped up two of Shire’s liver disease drugs after launching in November 2018, has made Alexey Kutahov general manager of EMEA (Europe, Middle East and Africa). Kutahov recently left Sarepta — hitting turbulence both with the FDA and with their data revealed last week for their Duchenne muscular dystrophy gene therapy — as their general manager of Europe. He has also been head of market access innovation at Amgen and head of central European market access at Novartis.

Jared Freedberg

→ It’s a tumultuous time at Intercept following last year’s NASH rejection at the FDA and departing CEO Mark Pruzanski’s salty words for the agency. This week the biotech has selected a new general counsel and secretary in 15-year Covance vet Jared Freedberg. He comes off two years as general counsel and secretary at Immunomedics, and prior to that, he was Mallinckrodt’s general counsel, specialty generics operating division and VP, business development and licensing.

→ Israel-based MeMed has named Troy Boutelle as VP of commercial, North America and general manager, US. Boutelle’s previous experience includes roles at Eurofins-Viracor and Thermo Fisher Scientific.

→ France’s Transgene has promoted Gaëlle Stadtler to the position of director of human resources. Stadtler joined the company as head of human resources and internal communications in 2018. Prior to that, Stadtler served in roles at L&L Products and Mars Inc.

→ UK-based Axol Bioscience has made the additions of Ross Wheatcroft as global strategic accounts manager and Kimberly LaPointe as global head of product management to its leadership team. Wheatcroft hails from Abcam, where he was commercial development manager, while LaPointe comes from BBI Solutions. 

→ As the dust settles on minority investor WaterMill’s successful activist attack and ouster of chairman Scott Tarriff, Ziopharm Oncology has found Tarriff’s replacement: James Huang. A member of the board since July, Huang is a driving force behind GenScript, Legend Biotech and Zai Lab and has been managing partner at Kleiner Perkins Caufield & Byers (KPCB) China since 2011. Additionally, Vineti co-founder Heidi Hagen has been chosen as Ziopharm’s lead independent director.

Tamar Thompson

→ As CSO Art Levin described his “dream” scenario working on antibody oligonucleotide conjugates this week at JP Morgan, La Jolla, CA-based Avidity Biosciences is mixing in some board news too with the departures of Todd Brady and Michael Martin and the additions of Tamar Thompson and Jean Kim to the board of directors. Thompson, a Bristol Myers Squibb alum, is Alexion’s VP, US government affairs and policy, while Kim was a partner at Deerfield Management from 2006-20. Elsewhere, Kura Oncology CEO Troy Wilson is moving from Avidity’s executive chairman to chairman.

Ryan Watts’ crew at Denali has made Kallyope CEO Nancy Thornberry a member of the board of directors. Before leading Kallyope, Thornberry ended a long career at Merck in 2013 as SVP and franchise head, diabetes and endocrinology.

David Pyott

→ Ex-Allergan chairman and CEO David Pyott has been given a seat at the board of director of South San Francisco fibrosis biotech Pliant Therapeutics, which hauled in an IPO that ended up totaling nearly $166 million back in June. Pyott, who ran Allergan from 1998-2015, is a board member at Alnylam and BioMarin.

Chris Nowers-led natural killer cell therapy shop ONK Therapeutics, which scored an $8 million financing round in October, has named longtime Novartis exec Hugh O’Dowd chairman. O’Dowd is coming off a four-year tenure as president and CEO of Neon Therapeutics.

Tom Wiggans

→ Ex-Dermira CEO Tom Wiggans has been elected executive chairman of Boston-based androgenetic alopecia biotech Follica. Wiggans, who is also on the boards of Annexon Biosciences and Forma Therapeutics, will be joined on Follica’s board by Michael Davin, the CEO of Cynosure from 2003-17.

→ Belgian CAR-T player Celyad Oncology has paved the way for Marina Udier to be on their board of directors. The CEO of Nouscom since last Feburary, Udier started as the Swiss biotech’s COO in 2016.

Kate Walsh

Boston Medical Center Health System president and CEO Kate Walsh is stepping in as a board member of Cambridge, MA-based CRISPR base editing player Beam Therapeutics. Walsh is formerly COO of Brigham and Women’s Hospital.

Anne Prener

→ Following its Series D funding with an $85 million IPO, fibrosis biotech Galecto has welcomed Anne Prener to the board of directors. The former Freeline Therapeutics CEO and Novo Nordisk alum is president and CEO of Imbria Pharmaceuticals.

Modulus Oncology has tapped Tim Edwards as chairman of its board of directors. Edwards currently serves as executive chair of Karus Therapeutics, non-executive chair of Storm Therapeutics and director of AstonauTX Limited. Edwards has previously served at InnovateUK and Enara Bio among others.

Teon Therapeutics has pulled in Glen Giovannetti to its board of directors. Giovannetti joins the board after his retirement from EY (Ernst & Young), formerly serving as global biotechnology and life sciences leader.

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Analyst reviews Apple stock price target amid challenges

Here’s what could happen to Apple shares next.

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They said it was bound to happen.

It was Jan. 11, 2024 when software giant Microsoft  (MSFT)  briefly passed Apple  (AAPL)  as the most valuable company in the world.

Microsoft's stock closed 0.5% higher, giving it a market valuation of $2.859 trillion. 

It rose as much as 2% during the session and the company was briefly worth $2.903 trillion. Apple closed 0.3% lower, giving the company a market capitalization of $2.886 trillion. 

"It was inevitable that Microsoft would overtake Apple since Microsoft is growing faster and has more to benefit from the generative AI revolution," D.A. Davidson analyst Gil Luria said at the time, according to Reuters.

The two tech titans have jostled for top spot over the years and Microsoft was ahead at last check, with a market cap of $3.085 trillion, compared with Apple's value of $2.684 trillion.

Analysts noted that Apple had been dealing with weakening demand, including for the iPhone, the company’s main source of revenue. 

Demand in China, a major market, has slumped as the country's economy makes a slow recovery from the pandemic and competition from Huawei.

Sales in China of Apple's iPhone fell by 24% in the first six weeks of 2024 compared with a year earlier, according to research firm Counterpoint, as the company contended with stiff competition from a resurgent Huawei "while getting squeezed in the middle on aggressive pricing from the likes of OPPO, vivo and Xiaomi," said senior Analyst Mengmeng Zhang.

“Although the iPhone 15 is a great device, it has no significant upgrades from the previous version, so consumers feel fine holding on to the older-generation iPhones for now," he said.

A man scrolling through Netflix on an Apple iPad Pro. Photo by Phil Barker/Future Publishing via Getty Images.

Future Publishing/Getty Images

Big plans for China

Counterpoint said that the first six weeks of 2023 saw abnormally high numbers with significant unit sales being deferred from December 2022 due to production issues.

Apple is planning to open its eighth store in Shanghai – and its 47th across China – on March 21.

Related: Tech News Now: OpenAI says Musk contract 'never existed', Xiaomi's EV, and more

The company also plans to expand its research centre in Shanghai to support all of its product lines and open a new lab in southern tech hub Shenzhen later this year, according to the South China Morning Post.

Meanwhile, over in Europe, Apple announced changes to comply with the European Union's Digital Markets Act (DMA), which went into effect last week, Reuters reported on March 12.

Beginning this spring, software developers operating in Europe will be able to distribute apps to EU customers directly from their own websites instead of through the App Store.

"To reflect the DMA’s changes, users in the EU can install apps from alternative app marketplaces in iOS 17.4 and later," Apple said on its website, referring to the software platform that runs iPhones and iPads. 

"Users will be able to download an alternative marketplace app from the marketplace developer’s website," the company said.

Apple has also said it will appeal a $2 billion EU antitrust fine for thwarting competition from Spotify  (SPOT)  and other music streaming rivals via restrictions on the App Store.

The company's shares have suffered amid all this upheaval, but some analysts still see good things in Apple's future.

Bank of America Securities confirmed its positive stance on Apple, maintaining a buy rating with a steady price target of $225, according to Investing.com

The firm's analysis highlighted Apple's pricing strategy evolution since the introduction of the first iPhone in 2007, with initial prices set at $499 for the 4GB model and $599 for the 8GB model.

BofA said that Apple has consistently launched new iPhone models, including the Pro/Pro Max versions, to target the premium market. 

Analyst says Apple selloff 'overdone'

Concurrently, prices for previous models are typically reduced by about $100 with each new release. 

This strategy, coupled with installment plans from Apple and carriers, has contributed to the iPhone's installed base reaching a record 1.2 billion in 2023, the firm said.

More Tech Stocks:

Apple has effectively shifted its sales mix toward higher-value units despite experiencing slower unit sales, BofA said.

This trend is expected to persist and could help mitigate potential unit sales weaknesses, particularly in China. 

BofA also noted Apple's dominance in the high-end market, maintaining a market share of over 90% in the $1,000 and above price band for the past three years.

The firm also cited the anticipation of a multi-year iPhone cycle propelled by next-generation AI technology, robust services growth, and the potential for margin expansion.

On Monday, Evercore ISI analysts said they believed that the sell-off in the iPhone maker’s shares may be “overdone.”

The firm said that investors' growing preference for AI-focused stocks like Nvidia  (NVDA)  has led to a reallocation of funds away from Apple. 

In addition, Evercore said concerns over weakening demand in China, where Apple may be losing market share in the smartphone segment, have affected investor sentiment.

And then ongoing regulatory issues continue to have an impact on investor confidence in the world's second-biggest company.

“We think the sell-off is rather overdone, while we suspect there is strong valuation support at current levels to down 10%, there are three distinct drivers that could unlock upside on the stock from here – a) Cap allocation, b) AI inferencing, and c) Risk-off/defensive shift," the firm said in a research note.

Related: Veteran fund manager picks favorite stocks for 2024

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Major typhoid fever surveillance study in sub-Saharan Africa indicates need for the introduction of typhoid conjugate vaccines in endemic countries

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high…

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There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

Typhoid Conjugate Vaccine Introduction in Madagascar vaccination

Credit: IVI

There is a high burden of typhoid fever in sub-Saharan African countries, according to a new study published today in The Lancet Global Health. This high burden combined with the threat of typhoid strains resistant to antibiotic treatment calls for stronger prevention strategies, including the use and implementation of typhoid conjugate vaccines (TCVs) in endemic settings along with improvements in access to safe water, sanitation, and hygiene.

 

The findings from this 4-year study, the Severe Typhoid in Africa (SETA) program, offers new typhoid fever burden estimates from six countries: Burkina Faso, Democratic Republic of the Congo (DRC), Ethiopia, Ghana, Madagascar, and Nigeria, with four countries recording more than 100 cases for every 100,000 person-years of observation, which is considered a high burden. The highest incidence of typhoid was found in DRC with 315 cases per 100,000 people while children between 2-14 years of age were shown to be at highest risk across all 25 study sites.

 

There are an estimated 12.5 to 16.3 million cases of typhoid every year with 140,000 deaths. However, with generic symptoms such as fever, fatigue, and abdominal pain, and the need for blood culture sampling to make a definitive diagnosis, it is difficult for governments to capture the true burden of typhoid in their countries.

 

“Our goal through SETA was to address these gaps in typhoid disease burden data,” said lead author Dr. Florian Marks, Deputy Director General of the International Vaccine Institute (IVI). “Our estimates indicate that introduction of TCV in endemic settings would go to lengths in protecting communities, especially school-aged children, against this potentially deadly—but preventable—disease.”

 

In addition to disease incidence, this study also showed that the emergence of antimicrobial resistance (AMR) in Salmonella Typhi, the bacteria that causes typhoid fever, has led to more reliance beyond the traditional first line of antibiotic treatment. If left untreated, severe cases of the disease can lead to intestinal perforation and even death. This suggests that prevention through vaccination may play a critical role in not only protecting against typhoid fever but reducing the spread of drug-resistant strains of the bacteria.

 

There are two TCVs prequalified by the World Health Organization (WHO) and available through Gavi, the Vaccine Alliance. In February 2024, IVI and SK bioscience announced that a third TCV, SKYTyphoid™, also achieved WHO PQ, paving the way for public procurement and increasing the global supply.

 

Alongside the SETA disease burden study, IVI has been working with colleagues in three African countries to show the real-world impact of TCV vaccination. These studies include a cluster-randomized trial in Agogo, Ghana and two effectiveness studies following mass vaccination in Kisantu, DRC and Imerintsiatosika, Madagascar.

 

Dr. Birkneh Tilahun Tadesse, Associate Director General at IVI and Head of the Real-World Evidence Department, explains, “Through these vaccine effectiveness studies, we aim to show the full public health value of TCV in settings that are directly impacted by a high burden of typhoid fever.” He adds, “Our final objective of course is to eliminate typhoid or to at least reduce the burden to low incidence levels, and that’s what we are attempting in Fiji with an island-wide vaccination campaign.”

 

As more countries in typhoid endemic countries, namely in sub-Saharan Africa and South Asia, consider TCV in national immunization programs, these data will help inform evidence-based policy decisions around typhoid prevention and control.

 

###

 

About the International Vaccine Institute (IVI)
The International Vaccine Institute (IVI) is a non-profit international organization established in 1997 at the initiative of the United Nations Development Programme with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health.

IVI’s current portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases that disproportionately affect low- and middle-income countries, such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV, COVID-19, and more. IVI developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO) and developed a new-generation typhoid conjugate vaccine that is recently pre-qualified by WHO.

IVI is headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, a Country Office in Austria, and Collaborating Centers in Ghana, Ethiopia, and Madagascar. 39 countries and the WHO are members of IVI, and the governments of the Republic of Korea, Sweden, India, Finland, and Thailand provide state funding. For more information, please visit https://www.ivi.int.

 

CONTACT

Aerie Em, Global Communications & Advocacy Manager
+82 2 881 1386 | aerie.em@ivi.int


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US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever… And Debt Explodes

Earlier today, CNBC’s…

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US Spent More Than Double What It Collected In February, As 2024 Deficit Is Second Highest Ever... And Debt Explodes

Earlier today, CNBC's Brian Sullivan took a horse dose of Red Pills when, about six months after our readers, he learned that the US is issuing $1 trillion in debt every 100 days, which prompted him to rage tweet, (or rageX, not sure what the proper term is here) the following:

We’ve added 60% to national debt since 2018. Germany - a country with major economic woes - added ‘just’ 32%.   

Maybe it will never matter.   Maybe MMT is real.   Maybe we just cancel or inflate it out. Maybe career real estate borrowers or career politicians aren’t the answer.

I have no idea.  Only time will tell.   But it’s going to be fascinating to watch it play out.

He is right: it will be fascinating, and the latest budget deficit data simply confirmed that the day of reckoning will come very soon, certainly sooner than the two years that One River's Eric Peters predicted this weekend for the coming "US debt sustainability crisis."

According to the US Treasury, in February, the US collected $271 billion in various tax receipts, and spent $567 billion, more than double what it collected.

The two charts below show the divergence in US tax receipts which have flatlined (on a trailing 6M basis) since the covid pandemic in 2020 (with occasional stimmy-driven surges)...

... and spending which is about 50% higher compared to where it was in 2020.

The end result is that in February, the budget deficit rose to $296.3 billion, up 12.9% from a year prior, and the second highest February deficit on record.

And the punchline: on a cumulative basis, the budget deficit in fiscal 2024 which began on October 1, 2023 is now $828 billion, the second largest cumulative deficit through February on record, surpassed only by the peak covid year of 2021.

But wait there's more: because in a world where the US is spending more than twice what it is collecting, the endgame is clear: debt collapse, and while it won't be tomorrow, or the week after, it is coming... and it's also why the US is now selling $1 trillion in debt every 100 days just to keep operating (and absorbing all those millions of illegal immigrants who will keep voting democrat to preserve the socialist system of the US, so beloved by the Soros clan).

And it gets even worse, because we are now in the ponzi finance stage of the Minsky cycle, with total interest on the debt annualizing well above $1 trillion, and rising every day

... having already surpassed total US defense spending and soon to surpass total health spending and, finally all social security spending, the largest spending category of all, which means that US debt will now rise exponentially higher until the inevitable moment when the US dollar loses its reserve status and it all comes crashing down.

We conclude with another observation by CNBC's Brian Sullivan, who quotes an email by a DC strategist...

.. which lays out the proposed Biden budget as follows:

The budget deficit will growth another $16 TRILLION over next 10 years. Thats *with* the proposed massive tax hikes.

Without them the deficit will grow $19 trillion.

That's why you will hear the "deficit is being reduced by $3 trillion" over the decade.

No family budget or business could exist with this kind of math.

Of course, in the long run, neither can the US... and since neither party will ever cut the spending which everyone by now is so addicted to, the best anyone can do is start planning for the endgame.

Tyler Durden Tue, 03/12/2024 - 18:40

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