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FDA approves Johnson & Johnson nasal spray Spravato for depression

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This photo provided by Janssen Global Services shows Spravato nasal spray.

Janssen Global Services via AP

The Food and Drug Administration on Tuesday approved Johnson & Johnson‘s nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow. 

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The spray, called Spravato, is now the first-ever standalone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient. 

Previously, Spravato was cleared in the U.S. to use together with an oral antidepressant for both treatment-resistant depression and for people with major depressive disorder who are experiencing thoughts of suicide or harm. The drug first entered the U.S. market in 2019. 

“We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview. 

Around one-third of the estimated 21 million U.S. adults with major depression battle symptoms — such as persistent feelings of sadness, sleep disturbances, low energy and thoughts of death or suicide — that don’t respond to treatment, according to some estimates

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“For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials. 

His center in St. Louis, Missouri, has treated more than 6,000 patients with the drug, and currently just over 100 people are taking it there. That is one of 3,000 outpatient treatment centers in the U.S. that are certified to administer Spravato, according to J&J’s tally.

Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills aren’t improving their symptoms and are causing undesirable side effects, such as weight gain and sexual issues. 

J&J’s Martin said the approval provides “an avenue for caregivers and their patients to really optimize, personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease. 

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That could potentially “open up the number of patients who could benefit” from Spravato, according to Martin. 

Spravato is on its way to becoming a blockbuster product, with the drug bringing in $780 million in sales during the first nine months of 2024 as doctors grow more comfortable using it, according to J&J’s third-quarter earnings. The company has even higher expectations for its growth, telling investors in December that it expects sales will increase to between $1 billion and $5 billion annually. 

That is a boon to J&J as it prepares for an upcoming patent expiration and new negotiated prices with Medicare to pressure sales of its top-selling inflammatory treatment, Stelara. 

The approval is based on a phase four trial, which showed that Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. The company has said that the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.

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Martin said that demonstrates “not only rapid symptom relief, but also a durable symptom relief” when patients take Spravato by itself. 

Spravato’s long road to rapid growth

Spravato blazed a new trail in 2019 as the first new major depression treatment to win FDA approval in more than three decades. The drug is related to ketamine, a common anesthetic that can have hallucinogenic effects and is sometimes misused recreationally. J&J made it into a nasal spray to get it into the brain quickly. 

Spravato “turns on neural networks in a way that’s different,” said Mattingly. 

“Our standard oral antidepressants took weeks to months to see if they’re going to work,” he added. “Quite often with the same day, the very next day, the very next day, people can already start to feel they’re feeling somewhat better” with Spravato.

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Spravato’s warning label cautions about the risk of sedation and dissociation, respiratory depression, suicidal thoughts and abuse or misuse of the drug, among other potential side effects. Because of that, Spravato is only available through a restricted program, meaning it can’t be purchased at a pharmacy and is only administered in certified health-care settings under strict supervision. 

Users of the medication must also be monitored by a health-care professional for two hours following administration.

Spravato’s launch had a sluggish start, especially as pandemic-related challenges complicated arrangements for the drug’s necessary medical supervision. But J&J began to market Spravato more heavily after in-person doctor visits became the norm again, and physicians became more aware of its benefits. 

“The mental health community wasn’t really used to doing procedures at that point. We weren’t used to having a space set aside. We weren’t used to thinking about how to do Spravato,” Mattingly said. “I think the good news is now we’ve all seen the benefits to our patients. So many of us have become really strong advocates” for it. 

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Five years of real-world data on the drug and a head-to-head study demonstrating Spravato’s superior efficacy to an oral antidepressant also gave doctors higher confidence in the treatment, according to J&J’s Martin.

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Trump-Backed Crypto Venture To Extend Token Sales

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Trump-Backed Crypto Venture To Extend Token Sales

Este artículo también está disponible en español.

The Financial Times reported on Monday that World Liberty Financial (WLF), the digital asset venture associated with President Donald Trump, has successfully raised $1 billion through its token sales. 

Initially launched in October with a goal of selling only 20 billion WLF tokens, the decentralized finance’s (DeFi) venture token surpassed this target by selling 21 billion tokens, demonstrating robust demand despite a rocky start.

Eric Trump Champions World Liberty Financial At ‘High-Profile Event’

Per the report, this surge in interest comes as WLF announces the release of an additional 5 billion tokens from its total supply of 100 billion, citing “massive demand and overwhelming interest.” 

The Trump family’s foray into the cryptocurrency space has been marked by a blend of enthusiasm and controversy. Over the weekend, both Donald Trump and his wife, Melania, launched their own memecoins, which experienced rapid spikes in value. 

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Eric Trump, actively promoting World Liberty Financial, also attended a “high-profile crypto event” in Washington, celebrating the intersection of politics and digital assets as his father prepares for a new administration.

Trump’s embrace of the crypto sector during his election campaign has resonated with industry executives, many of whom anticipate a more favorable regulatory environment compared to the policies of the outgoing Biden administration. 

The appointment of crypto-friendly figures, such as Paul Atkins to lead the Securities and Exchange Commission (SEC) and David Sacks as the newly created artificial intelligence (AI) and Crypto Czar, further underscores this potential shift. However, the venture has not been without its critics. 

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Trump’s Memecoins Spark Controversy

Concerns arise over the limited rights associated with WLF tokens, which provide holders with only minimal voting rights and no economic entitlements. Furthermore, the tokens cannot be traded or sold back to WLF, leading to questions about their long-term value and utility.

Compounding the intrigue surrounding WLF, notable crypto entrepreneur and TRON blockchain founder Justin Sun recently revealed a significant investment of $45 million into the venture, raising his total stake to $75 million. 

The market’s reaction has been volatile, exemplified by Bitcoin’s brief spike to a record high of over $109,000 on Monday, followed by a retraction toward $102,000 after Trump’s inauguration speech. 

Analysts now speculate that upcoming executive orders from Trump could bolster the crypto industry’s fortunes in the US, although skepticism lingers among some industry veterans. 

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Nic Carter, a venture capitalist, articulated concerns about the “ethical implications” of a sitting president engaging in business ventures that could be perceived as “conflicts of interest.”

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The launch of Trump’s memecoins has also stirred controversy, with the Donald Trump memecoin experiencing a sharp decline from a weekend high of $75 to $52. 

Meanwhile, the Melania Trump memecoin, which disrupted the market dynamics of the Donald coin, saw its value fluctuate significantly from a high of $13.64 to $8.43.

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Bernstein analysts have noted that this “chaotic crypto era” marks a critical juncture, suggesting that government engagement with cryptocurrencies may redefine the relationship between leadership and emerging technologies. 

The analysts assert that the launch of Trump and Melania’s memecoins signifies a potential regulatory shift in the country, where digital assets could serve as a direct connection to a mass audience.

World Liberty Financial
The daily chart shows the total crypto market cap valuation at $3.42 trillion. Source: TOTAL on TradingView.com

Featured image from DALL-E, chart from TradingView.com

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Sam Altman, Larry Ellison and Masayoshi Son join Trump to announce massive $500 billion Stargate project with the SoftBank CEO as chairman

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Masayoshi Son (L), Chairman and CEO of SoftBank Group Corp, Larry Ellison (C), Executive Charmain Oracle and Sam Altman (R), CEO of Open AI listen to US President Trump speaks in the Roosevelt Room at the White House on January 21, 2025, in Washington, DC.

Masayoshi Son (L), Chairman and CEO of SoftBank Group Corp, Larry Ellison (C), Executive Charmain Oracle and Sam Altman (R), CEO of Open AI listen to US President Trump speaks in the Roosevelt Room at the White House on January 21, 2025, in Washington, DC.

Photo by JIM WATSON/AFP via Getty Images

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MicroStrategy Bitcoin (BTC) Holdings Rise to 461K

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Disclaimer: The analyst who wrote this piece owns shares of MicroStrategy (MSTR).

Led by Executive Chairman Michael Saylor, MicroStrategy (MSTR) has again added to its massive bitcoin (BTC) stack.

In the week ending Jan 19, the company purchased 11,000 BTC for $1.1 billion, taking its total holdings to 461,000 BTC. This latest bitcoin average purchase price was $101,191, increasing MicroStrategy’s overall average purchase price to $63,610.

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Once again, Michael Saylor teased the announcement on X on Sunday with the caption, “Things will be different tomorrow.” Since the tweet, Saylor has posted multiple photos of himself with Eric Trump, crypto czar David Sacks and Robert Kennedy Jr.

MSTR shares are down modestly in premarket action, with bitcoin trading at $104,500, lower by a hair from late Friday afternoon. U.S. stocks were closed on Monday due to the MLK holiday.

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Quordle today – my hints and answers for Wednesday, January 22 (game #1094)

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Quordle today – my hints and answers for Tuesday, December 17 (game #1058)

Quordle was one of the original Wordle alternatives and is still going strong now more than 1,000 games later. It offers a genuine challenge, though, so read on if you need some Quordle hints today – or scroll down further for the answers.

Enjoy playing word games? You can also check out my NYT Connections today and NYT Strands today pages for hints and answers for those puzzles, while Marc’s Wordle today column covers the original viral word game.

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Dogwifhat and Pepe Price Predictions Now Trump's Meme Coin Has Hit The Market; Remittix Could Rally 5000% In 2025

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Dogwifhat and Pepe Price Predictions Now Trump's Meme Coin Has Hit The Market; Remittix Could Rally 5000% In 2025

Although cryptocurrency has always been an unpredictable journey, 2025 may be the year that it takes things to the next level. Remittix, still in its presale phase, is receiving a lot of interest among the new competitors. Having raised around $4 million to date, some analysts estimate a 100x spike in 2024, making Remittix’s 2025 price rally one of the largest in the meme currency field. 

You’re not the only one who is unsure if now is the right moment to join in on the fun. When compared to other up-and-coming stars like Dogwifhat and Pepe coin, investors are closely monitoring Remittix. However, why the hype? In the upcoming year, will Remittix surpass Dogwifhat, or are both tokens set for a huge surge?

Why Are Investors Flocking to Meme Coins in 2025?

Although meme coins have always been popular, the industry appears to be expanding to unprecedented levels in 2025. Meme coins are still very much in use because of the hype around tokens like Dogwifhat and Pepe coin. Coins like Dogwifhat and Pepe coin are becoming popular as both investors and cryptocurrency fans get on the meme coin bandwagon. If you know where to search, meme coins may yield enormous rewards for both novice and experienced cryptocurrency investors.

Remittix is also making headlines for all the right reasons. Investors looking for the next great thing have taken notice of Remittix, whether it is because of its success in the presale or the community it fosters. On the other hand, Dogwifhat price prediction is also showing potential, although it hasn’t generated as much excitement as Remittix yet.

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It is important to remember that meme coins are more than just trends or jokes. They are a developing area of the cryptocurrency industry where early investors stand to gain significantly. Remittix’s 2025 price surge may provide huge profits, but only for investors who act quickly.

Why Is Remittix Getting So Much Attention?

Despite Remittix still being in its presale phase, it is already showing signs of huge potential. The excitement around the Remittix 2025 price surge is rapidly growing, with over $3.7million raised. With predictions that this coin will increase 100 times in the next year alone, early investors are thrilled. More people are joining the presale in an attempt to reserve their seats as it becomes more popular.

Many experts think that Remittix will surpass Dogwifhat and Pepe in no time. They see it as a new contender that is bound to take over the market in 2025.

How Do Dogwifhat and Pepe Coin Compare to Remittix?

Dogwifhat price analysis makes it evident that the meme coin market is expanding and changing. Investors want to know if Remittix will seize the lead or if Dogwifhat can keep beating forecasts. Many people think that Remittix may be the next big thing in 2025, even if Pepe and Dogwifhathave had their share of fame. 

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Remittix is now one of the most talked-about tokens due to its success during the presale, and the hype around it has already surpassed that of many others. The Remittix 2025 price rally could be one of the most significant events in the crypto space. Remittix offers a fresh, exciting opportunity for those looking to get in on a token with significant upside potential; Remittix’spotential is enough to get more people on board. 

But what if Dogwifhat is still in the game? Though the future is still very much up in the air, many predict that the battle between Dogwifhat and Remittix might heat up.

Don’t Miss Out On Remittix

With the 2025 price rally approaching, now is the ideal moment to invest in Remittix, which has already demonstrated that it is a competitor in the meme coin space. Remittix is proving to be a must-watch token in the coming year, regardless of whether you’re a fan of Dogwifhat, Pepe coin, or other meme coins like Pepe. Don’t pass up this fantastic chance to get on the winning team.

Find out more about Remittix and be a part of its future by checking its presale here:

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Website: https://remittix.io/

Socials: https://linktr.ee/remittix

Disclaimer: This is a sponsored press release and is for informational purposes only. It does not reflect the views of Crypto Daily, nor is it intended to be used as legal, tax, investment, or financial advice. 

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Trump’s Plan to Leave the WHO Is a Health Disaster

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“President Trump is trying to downsize the WHO, and the question is whether other high-income nations like those in Europe, Australia, Japan, and elsewhere, pick up some of the slack,” says Vermund. “Will the Gates Foundation, which has been a very generous donor, pick up some? It’s conceivable that others will tide things over until we have a new administration that might be more friendly to the WHO, but I’m dubious that they can pick up the entire chunk of the WHO budget which is paid for by the US.”

And it isn’t just money that the US provides to the WHO, but staff and expertise too. “The Centers for Disease Control and Prevention has seconded a number of staff to the WHO, and I would predict that the Trump administration, with a new CDC director, will call those folks home,” says Vermund. “That would create quite a gap, because WHO funds do not pay for those individuals. So I think you’d have an almost immediate reduction of workforce and removal of critical professionals within the WHO organization.”

According to Gostin, a lot of the money the US provides to the WHO is core mandatory funding, which all members are required to give, but some funds are particularly earmarked for causes in which the US has a vested interest, such as polio eradication, HIV/AIDS, and the process of identifying and controlling disease outbreaks before they spread and reach American shores. Without US funding, Gostin says that these programs wouldn’t completely disappear, but they would be significantly weakened.

“Polio could come surging back,” says Gostin. “Remember we had polio in the wastewater in New York just a couple of years ago, and our kids are not being immunized. And we’ve had other real health scares in the United States, not just Covid-19, which killed more than a million people. We’ve had Zika, and the next health emergency might be just a mutation or two away. Maybe it’s already here in the form of avian influenza, and we’re going to need WHO to help us with that.”

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Both Gostin and Vermund fear that withdrawing from the WHO will place the US at the back of the line when it comes to receiving critical information such as pathogen samples and genomic sequencing data, which pharmaceutical companies require to generate effective vaccines. Gostin cites how the US relies on WHO data every year to effectively update the seasonal influenza vaccine, while Vermund explains that financially speaking, it is far more efficient for the US to fund the WHO to help “snuff out” diseases at their source, rather than trying to tackle them when they arrive in the country.

“We spent over $2 billion preparing for Ebola to hit US shores in 2014 and 2015, and since we only had five or six cases, that was very cost-ineffective,” says Vermund. “So that’s a typical example of how when the US goes it alone, it will be very inefficient compared with contributing to a multinational response to control a disease in the country of origin.”

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Trump pardons Silk Road creator Ross Ulbricht

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US President Donald Trump has followed through on his promise to pardon Ross Ulbricht, the founder of the online drug market Silk Road, who was imprisoned for over a decade.

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Record Beef Imports Raising Risk of China Imposing Trade Curbs

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China’s record beef imports are hitting a market where demand is slowing and prices have fallen to the lowest since 2019, raising the risk that authorities will take steps to curb the trade.

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DWP launches ‘biggest benefit fraud crackdown’ as Labour unveils new controversial tough measure

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DWP launches 'biggest benefit fraud crackdown' as Labour unveils new controversial tough measure

Benefit fraudsters who cheated taxpayers out of £7billion last year could face driving bans under sweeping new powers announced by the Department for Work and Pensions (DWP).

The legislation, introduced in Parliament today, represents the biggest fraud clampdown in a generation. Repeat offenders who refuse to repay their debts could be disqualified from driving for up to two years.


The new measures will give DWP investigators the power to apply for search warrants, allowing them to work alongside police to search premises and seize evidence like computers and smartphones.

The crackdown comes as part of wider plans from the Labour Government to save £8.6billion over five years through tackling welfare fraud and error. Officials say the current system is costing taxpayers around £10billion annually, with £35billion incorrectly paid out since the pandemic.

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The new legislation will target fraudsters who owe £1,000 or more and have repeatedly ignored requests to repay their debts. DWP officials will need to apply to courts to justify suspending driving privileges in these cases.

Do you have a money story you’d like to share? Get in touch by emailing money@gbnews.uk.

Liz Kendall and benefit fraudster

The Government has unveiled new rules to clampdown on benefit fraudsters

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The Bill is expected to save the Department £1.5billion over the next five years. The measures will be based on principles of fairness and proportionality, with driving bans used only as a last resort.

Officials will prioritise negotiating affordable and sustainable repayment plans with offenders before pursuing more severe penalties. The legislation forms part of the government’s Plan for Change, which aims to reform the health and disability welfare system.

New proposals for reforming health and disability benefits are expected in the Spring. Work and Pensions Secretary Liz Kendall said: “We are turning off the tap to criminals who cheat the system and steal law-abiding taxpayers money.”

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She emphasised the serious consequences for fraudsters, including the potential loss of driving privileges in extreme cases. “Backed up by new and important safeguards including reporting mechanisms and independent oversight to ensure the powers are used proportionately and safely,” Kendall added.

Liz Kendall

DWP Minister Liz Kendall is promising to tackle benefit fraud

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“People need to have confidence the Government is opening all available doors to tackle fraud and eliminate waste, as we continue the most ambitious programme for government in a generation – with a laser-like focus on outcomes which will make the biggest difference to their lives as part of our Plan for Change.”

Under the new powers, DWP will be able to recover money directly from bank accounts of those who owe money and refuse to pay, despite having the means to do so.

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However, the Department will not have direct access to people’s bank accounts. The legislation will allow DWP to request bank statements to prove debtors have sufficient funds to repay what they owe.

These measures are part of a modernised approach to catching fraudsters and preventing overpayments. The new system aims to keep pace with sophisticated fraud while ensuring legitimate claimants receive the correct benefits.

Officials say this will help prevent vulnerable customers from falling further into debt. The powers will apply to individuals who are not on benefits or in PAYE employment but still owe money to the Department. The legislation includes comprehensive safeguarding measures to protect vulnerable customers.

LATEST DEVELOPMENTS:

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Cars driving and a vehicle ban sign

Benefit fraudsters could be banned from driving under Government plans

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Staff will receive high-level training on the appropriate use of new powers. New oversight and reporting mechanisms will be introduced to monitor how these powers are used.

Furthermore, Government will develop Codes of Practice, which will be subject to consultation during the Bill’s passage. All powers will have clearly defined scope and limitations, including the right to appeal decisions.

The Cabinet Office’s Public Sector Fraud Authority will receive additional powers under the new legislation. Georgia Gould, Minister in the Cabinet Office, said: “During the pandemic, when people and businesses needed government support the most, some people stole public money for their own personal gain.”

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The time limit for civil claims against Covid fraud will be doubled from six to twelve years. This extension will give investigators more time to examine complex cases and apply new powers retrospectively. These powers include the ability to raid properties and retrieve money from Covid fraudsters’ bank accounts.

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Trump says he’s open to Musk or Ellison buying TikTok

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President Donald Trump says he’d be open to his buddies Elon Musk or Larry Ellison buying TikTok.

“Larry, let’s negotiate in front of the media,” Trump said at a press conference with the Oracle co-founder, SoftBank CEO Masa Son, and OpenAI CEO Sam Altman to announce a $500 billion artificial intelligence infrastructure investment. “What I’m thinking about saying to somebody is, buy it, and give half to the United States of America. Half, and we’ll give you the permit. And they’ll have a great partner, the United States.”

“Sounds like a good deal to me, Mr. President,” Ellison said.

TikTok’s China-based parent company ByteDance still has other offers on the table, including from billionaire Frank McCourt’s Project Liberty and now, apparently, from YouTube creator MrBeast — whose investor group is receiving legal counsel from a team that includes the brother of Trump’s attorney general pick.

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As he was leaving the briefing, a reporter asked Trump if he has TikTok on his phone. “No, but I think I might put it there,” Trump responded. “I think I’ll get it right now.”

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