Jensen Huang, FDA Commissioner Makary, & Beast Industries CEO 2/26/26

Summary

Squawk Pod – February 26, 2026

Detailed Summary

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Overview

This episode of “Squawk Pod” (2/26/26) dives into three headline interviews from CNBC’s “Squawk Box”:

• Jensen Huang, CEO of Nvidia, discusses Nvidia’s blockbuster earnings, the AI industrial revolution, emerging competition, and the Pentagon’s standoff with Anthropic.
• FDA Commissioner Dr. Marty Makary lays out major policy reforms for rare disease treatment, transparency in drug approvals, and responds to controversy inside the agency.
• Jeff Housenbold, CEO of Beast Industries, details Mr. Beast’s global content empire, addresses prediction market ethics, and unveils moves into fintech and beyond.

Hosts Becky Quick, Joe Kernan, and Andrew Ross Sorkin provide context, ask probing questions, and keep the tone brisk and occasionally playful.

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Nvidia’s Jensen Huang: AI’s New Industrial Revolution

Segment: 02:05–09:52

Key Discussion Points

• Nvidia’s Dominance & Growth

  • Nvidia posted 75% YoY revenue growth in its core data center business, holding about 95% market share.
  • Demand for Nvidia chips “is really strong and it’s diverse. It’s coming from all over the place.” (Jensen Huang, 02:45)
  • The AI compute “inflection points” were cited as a driver—originally with ChatGPT; then reasoning AI; now, “Agentix systems” that can actually “do work” (02:45).

• AI is a Universal Disruptor

  • “AI is a new way of doing software and affects every single industry... every industry will be transformed and every country will power it.” (Huang, 04:11)
  • AI’s broadening from chatbots to code, automobiles (robotaxis), scientific computing, across all sectors.

• Competitive Landscape & Law of Large Numbers

  • Becky notes AMD’s deal with Meta and growing competition; new Nvidia chips (“Vera Rubins”) rolling out to hold share (05:24).
  • Panel ponders: Can Nvidia keep up “75% revenue growth”? Is the “law of large numbers” finally catching up? “How do you do a $5 trillion company? I guess it goes to ten trillion.” (Unknown commentator, 06:24)

• Valuation Skepticism

  • Despite meteoric growth, Nvidia’s P/E ratios are lower than other chipmakers. “They may even continue to beat on all metrics next quarter.” (07:26)
  • Stock volatility noted—“At one point up three and a half to four percent... now up by less than 1%.” (Becky Quick, 07:42)

• AI Replacing Jobs

  • Hosts joke about jobs replaced by “GenTech AI”—with some playful ribbing about anchors themselves being replaced.
  • “I think you might be replaced by AI, but yeah, not you.” (Andrew Ross Sorkin, 08:06)
  • “Max Headroom.” (Becky Quick, 08:11)

• Vendor Financing Concerns

  • Huang’s massive cash stockpile ($20 billion increase) helps allay fears about vendor financing risk (08:31).
  • “If you were worried about the vendor financing, that tells you that they have money to spread around.” (Becky Quick, 08:31)

• AI Arms Race

  • AWS, Google, Meta among the hyperscalers needing to spend “$670 billion to build out just their AI infrastructure.” (09:13)

Notable Quotes

• “AI is a new industrial revolution.”
  — Jensen Huang (01:16, repeated at 04:11)
• “The amount of computing demand is off the charts.”
  — Jensen Huang (02:45)

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Anthropic, Pentagon, and AI Safety

Segment: 10:27–14:15

Key Discussion Points

• Government vs. AI Startups

  • The Pentagon is pressuring Anthropic for wide-ranging access to its models, considering labeling them a “supply chain risk” (10:27).
  • “Here we are in a standoff that is actually, I think, a much bigger deal than maybe we’re even giving it credit for...” (Andrew Ross Sorkin, 11:12)

• Anthropic’s Safety Commitment

  • Anthropic is viewed as the most safety-conscious AI company, but there are signs “they’re lessening that...to be more competitive.” (Andrew Ross Sorkin, 11:46)
  • “There’s the safety issue...and the fact that they’re lessening that in their...safety bridge.” (11:46)

• Jensen Huang’s Take

  • “The Defense Department has the right to use technology...for their needs...Anthropic, of course, has the right to decide how they market their products. I think they both have their reasonable perspective...If it doesn’t get worked out, it’s also not the end of the world.” (Jensen Huang, 12:27)
  • Reassurance that “AI is not the only game in town” for governments or companies globally.

Notable Quotes

• “I hope they can work it out. But if it doesn’t...it’s also not the end of the world.”
  — Jensen Huang (12:27)
• “Claude and Anthropic, in particular, they’ve been the most worried about safety of all of the companies.”
  — Andrew Ross Sorkin (11:22)

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Dr. Marty Makary: FDA Modernization & Rare Disease Reform

Segment: 16:36–30:20

Key Discussion Points

• Rare Disease as a Focus

  • “Rare isn’t really all that rare at all. Rare diseases impact about 30 million Americans.” (Becky Quick, 16:36)
  • Makary spearheading shift from treating rare diseases as an “afterthought” to making them the main focus (17:16).

• Reform Highlights

  • Tax credits, waived application fees, extended exclusivity, plus new “innovation hub” for standardized review.
  • Pediatric Priority Voucher Program renewed, providing $100–$200 million transferable voucher for rare disease drug approvals (14:38, 17:16).
  • “Plausible mechanism pathway”: For ultra-rare diseases, “if there’s a mechanism that makes sense...we’re going to go ahead and green light that therapy.” (Dr. Makary, 18:30)

• Transparency & Accountability

  • “If we reject a drug, the public deserves to know why ...for the first time in history, our letters detailing why a drug has not been accepted ...is now public information in real time.” (Dr. Makary, 20:42)

• Regulatory Flexibility & Speed

  • Moving from traditional randomized control trials toward Bayesian statistics and global data aggregation.
  • Goal: Reduce drug review times “from a year down to a number of weeks.” (Dr. Makary, 22:49)
  • “We’re going from a requirement of two clinical trials down to one. And that alone is going to allow companies to put twice as many drugs through the process.” (Dr. Makary, 22:49)

• Responding to Criticism About FDA Internal Politics

  • Addresses Wall Street Journal’s critique focused on Dr. Vinay Prasad and the role of randomized control trials—a “smear campaign” according to Makary (20:42, 22:49, 24:53).
  • Affirms that randomized trials aren’t always required for rare/life-threatening diseases; flexibility is the new norm (25:59).
  • “If the trial shows no benefit...then there are two sides to that story...that’s why our decision letters are public.” (Dr. Makary, 26:23)

• Defending FDA Talent

  • On Dr. Vinay Prasad: “He’s a genius. He’s on loan from UCSF. He’s published over 500 scientific peer-reviewed articles...” (Dr. Makary, 22:49)
  • Reiterates focus on scientific excellence, not partisan politics.

• Surgeon General Nominee Kasey Means

  • Defense of her stance on vaccines, food as medicine, and “fresh new ideas in health care.” (Dr. Makary, 28:22)

Notable Quotes

• “We decided at the FDA that if we reject a drug, the public deserves to know why. So for the first time in history, our letters...are now public information in real time.”
  — Dr. Marty Makary (00:48, expanded at 20:42)
• “We’re going to have more regulatory flexibilities...if there’s a mechanism that makes sense, we wave all the clinical trial requirements...”
  — Dr. Makary (18:30)
• “Kasey Means is the best person for the job...We need fresh new ideas in health care. And she’s the perfect person for that.”
  — Dr. Makary (28:22)

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Beast Industries & Mr. Beast: Beyond YouTube

Segment: 32:01–41:44

Key Discussion Points

• Scale & Reach

  • Mr. Beast is now at “468 million subscribers on YouTube...and over a billion across our platforms.” (Andrew Ross Sorkin & Jeff Housenbold, 33:06)
  • “In the last 90 days alone, 1.5 billion unique people around the world have watched our content. 80% of those outside the United States. Jimmy is a global phenomenon.” (Jeff Housenbold, 33:42)

• Content Platform Evolution

  • Vision: Move from single-creator brand (Mr. Beast “akin to Mickey Mouse”) to a larger entertainment platform, emulating Disney’s multi-character universe (34:59).
  • “We’re moving away from an individual to building an entertainment platform that will allow for other content and other talent to emerge and rise as a star.” (Jeff Housenbold, 34:59)

• Prediction Market Controversy

  • Recent controversy over an employee betting on KALSI regarding Beast Games outcomes; company already had ethics policies in place, employee suspended pending investigation (36:02–36:44).
  • “Prediction markets are going to have to self police, but...that’s not sufficient.” (37:32)
  • “You could be a third party cameraman on set...there’s so much information out there...people are taking advantage of that.” (Jeff Housenbold, 38:39)

• Fintech Move – Acquisition of Step

  • Beast Industries acquired Step, a fintech targeting financial literacy for youth (39:09).
  • Plan is to gamify financial education using Mr. Beast’s reach and appeal to Gen Z/Alpha.

• Web3 & Diversification

  • Beast Industries is invested in BitMine (Ethereum staking, DeFi). “Ethereum is the backbone of Stablecoin and the blockchain. We’re big fans of Ethereum.” (40:45)
  • Plans to expand from media/consumer products to telecoms and financial services.

Notable Quotes

• “There’s seven more billion people to get.”
  — Jeff Housenbold, on growth potential (33:25)
• “Mr. Beast is akin to Mickey Mouse, very important character...but they have Lucas and Star Wars and Marvel...We’re moving away from an individual to building an entertainment platform.”
  — Jeff Housenbold (34:59)
• “Prediction markets are going to have to self police, but I don’t think that's sufficient...It is ripe for abuse and our concern is to protect the little people.”
  — Jeff Housenbold (37:32)
• “We’re going to make [financial literacy] entertaining, we’re going to gamify it...to help drive the habits that lead to long term success for the masses.”
  — Jeff Housenbold (39:09)

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Memorable Moments

• Jensen Huang on AI’s Ubiquity:
  “AI is fundamentally a new way of doing software...every single company is affected, every industry will be transformed.” (04:11)

• Dr. Makary on Transparency:
  “If your drug works, it’s going to get approved by the FDA. And let’s just remember, there are moneyed interests.” (20:42)

• Beast CEO on Brand Expansion:
  “Think about Jimmy Donaldson, he’s akin to Walt Disney, a brilliant storyteller using the medium of his time to create content that engages… And Mr. Beast is akin to Mickey Mouse...” (34:59)

• Beast CEO on Prediction Market Dangers:
  “It is ripe for abuse and our concern is to protect the little people...Just like the casino companies have to do.” (37:32)

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Timestamps for Key Segments

• Nvidia & Jensen Huang: 02:05–09:52
• Anthropic & Pentagon Showdown: 10:27–14:15
• FDA Commissioner Dr. Makary: 16:36–30:20
• Mr. Beast/Beast Industries & Jeff Housenbold: 32:01–41:44

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Overall Tone & Takeaways

• The episode balances optimism about technology and healthcare innovation (Huang, Makary) with pragmatism about risks (vendor financing, AI safety, prediction market abuse).
• Personal asides and quips keep the tone energetic and accessible, especially in the Mr. Beast/Beast Industries and AI segments.
• Policy and tech news are discussed with rare depth, especially on FDA transparency reforms and the ethical challenges of next-gen content and AI.

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This summary captures the episode’s structure, central ideas, spirited debate, and provides a guide to key moments for listeners or readers who want an in-depth understanding without hearing the full show.

Transcript

[Becky Quick]

Hello, I'm Laura Castleton with Janice Henderson Investors. We work to help our clients achieve superior financial outcomes and fulfill our purpose of investing in a brighter future together. To learn more, go to Janashenderson.com try

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[Becky Quick]

Angelsoft soft and strong.

[Andrew Ross Sorkin]

Simple. Bring in show music please.

[Joe Kernan]

Hi, I'm CNBC producer Zack Villisi. Today on Squawkpod, FDA Commissioner Dr. Marty Makari is pushing for changes in our health system. More approvals, more rare disease treatment and more transparency.

[Dr. Marty Makary]

We decided at the FDA that if we reject a drug, the public deserves to know why. So for the first time in history, our letters detailing why a drug has not been accepted, detailing that we gave guidance that was not followed. Detailing why the clinical trial showed no benefit. That is now public information in real time.

[Joe Kernan]

In the AI world, Nvidia reported strong earnings and guidance. CEO Jensen Huang spoke to our own Becky Quick.

[Jensen Huang]

AI is a new industrial revolution.

[Joe Kernan]

Huang even weighs in on the other AI story of the morning, the Pentagon's showdown with Anthropic.

[Andrew Ross Sorkin]

Here we are in a standoff that is actually I think a much bigger deal than maybe we're even giving it credit for.

[Joe Kernan]

Plus the Beast Games finale in the books and season three already underway. Beast Industries CEO Jeff Housenbolt on producing Mr. Beast, the most followed person on the Internet with 1 billion followers across all platforms.

[Andrew Ross Sorkin]

How much more can that grow?

[Jeff Housenbold]

There's seven more billion people to get.

[Joe Kernan]

It's Thursday, February 26th. Squawk Pod begins right now.

[Andrew Ross Sorkin]

Stand Becky by in three, two, one.

[Becky Quick]

Good morning everybody. Welcome to Squawk box right here on CNBC. We are live from the NASDAQ MarketSite in times Square. I'm Becky Quick along with Joe Kernan and Andrew Ross Sorkin. Chip giant Nvidia reporting better than expected fourth quarter results. It was driven by revenue growth, growth of 75% in its core data center business. That's a business that's very important to in video they control about 95% of that market. They see profit margins or gross margins of 75%. They are the 800 pound gorilla and then some when it comes to all of this. And we spoke with Nvidia CEO Jensen Huang about that revenue growth and chip demand. First on cnbc.

[Jensen Huang]

Demand is really strong and it's diverse. It's coming from all over the place. At the core of it, Becky, what's Happen is that AI just went through its third inflection the first one was two years ago with ChatGPT, and then the second one was about a year ago when the reasoning AI agents came out, reasoning AI systems came out, and the number of tokens, the amount of computing demand that it needed to be able to reason and produce all the excellent answers that these chatbots were doing was really sky high. And then now with these Agentix systems, we're now having these agents able to reason, take task and actually do work. The Agentix systems are doing incredibly well all over the world. Of course, you've heard how cloud code and OpenAI's codex are doing incredibly well in companies all over the world in software programming, but it's starting to spread out into all these different other types of tasks. At the core, it's because AI has gone through a new inflection point and the amount of computing demand is off the charts.

[Becky Quick]

Well, let's talk a little bit about your customers too, because you did say that the big companies, the big hyperscalers, actually increased the amount of spending and I think they make up about half of the spending that went into the data center segment in particular. But you said the other customers were growing really quickly and that's where so much of the growth came from. Who are those other customers?

[Jensen Huang]

You know, Most people see AI as a chat bot and it's understandable because OpenAI is so popular and they're doing so well. And we hear a lot about cloud code. But remember, AI is about a new way of doing software and affects every single industry. Nvidia is really fortunate in the sense that we are the computing platform, the accelerated computing platform for every cloud, for any model, as well as every different domains of science. And so we're seeing success, whether it's in small cloud service providers, regionally around the world. It could be an enterprise. Our big partnership with Lilly, we have many others, car companies that are building autonomous vehicles. The Robotaxi era is coming and so there's a whole bunch of computing being built for that. Scientific computing is being completely revolutionized by artificial intelligence. And so the number of industries that are affected by AI, because AI is fundamentally a new way of doing software, is going to be very broad based. And that's one of the reasons why I say AI is a new industrial revolution, because every single company is affected, every industry will be transformed and every country will power it. And so it's broad based.

[Becky Quick]

Again, though, you talk about their market share of that data center chips 95%. The estimates run from 90 to 98%, but about 95%. And when you have margins like that, 75% it's obviously a market that lots of others want to get involved with. You did hear earlier this week about AMD cutting a deal with Meta. That's supposed to be a multi year deal that they're going to be looking at as well. You have all kinds of competitors who are trying to get in on that, but you also have Nvidia kind of running as fast as they can. The new chips that are going to be rolled out. They talked about those new chips that are coming. Vera Rubins that will be the second half of this fiscal year and that is the way that they are planning to try and keep some of that market share. We'll show you more excerpts from this interview a little later today. Just talking about the competition they're facing, talking about what he sees with the SAS apocalypse or whatever you want to call this. Just where the SAS companies are really under pressure because you also heard a report last night from Salesforce that stock was trading a little lower on some of these questions. But we'll get Jensen's take on whether this is overdone in the market.

[Unknown Male Commentator]

Just how long can you keep running ahead of the law of large numbers? Yeah and that seems like that always. That's like Einstein could have proposed a physical law that there's something called the law because kind of. But no one's ever. You can't break through the law of law. But AI might be. So it may be different this time so that you can. How do you do a $5 trillion company? How do you. How do you double a $5 trillion. I guess it goes to 10 trillion. Yeah.

[Andrew Ross Sorkin]

Look OpenAI is a good example of a company that had a valuation of $200 billion and $400 billion and 55

[Unknown Male Commentator]

now and you're getting 75% revenue growth on what number did they get the 75 on it was $68.1 billion is what they did now is what they did this year. So do you do 75 on 68 next year?

[Becky Quick]

Well that's where the doubters come in. And if you look at the. The valuation that the street gives just in terms of P E ratio they are valuing in video at lower ratios than they are any of the other chips at this point.

[Unknown Male Commentator]

People say because of exactly what the bears say it's price for. For perfection. It's almost price. You are assuming they're going to be on all metrics perfection with where it is. But they may even continue to beat on all metrics Next quarter and the

[Becky Quick]

quarter after the guidance that they issued for the current quarter in terms of revenue, it was $5 billion above what the street was expecting. And still you saw the stock at one point up three and a half to four percent. It dropped while I was talking to him yesterday and now it looks like it's up by less than 1%.

[Unknown Male Commentator]

So have you thought, both of you about how many things would be replaced by Gentec AI? I've only thought about travel agents and a couple of things. How many things are there?

[Andrew Ross Sorkin]

I think you might be replaced by

[Unknown Male Commentator]

AI, but yeah, not you.

[Becky Quick]

Max Headroom.

[Andrew Ross Sorkin]

No, I'm, I'm going first. Did he speak at all to this, the circular stuff, the whole idea of this sort of vendor financing? Because vendor financing can work in certain instances. By the way, you know, Boeing does vendor like people do vendor finance used

[Unknown Male Commentator]

to do some great.

[Becky Quick]

We didn't get into in depth with that. But if you looked at the numbers yesterday, the cash flow that they had at the end or the cash and cash equivalents that they had at the end of the quarter was $20 billion more than it had been. And other analysts were looking at that, saying if you were worried about the vendor financing, that tells you that they have money to spread around. The other issue is that so much of the vendor financing is kind of pointing at areas where you could see a real bottleneck for AI to try and move forward. At one point people thought it was the Nvidia chips, but they said they've got supply to last several quarters. Looking out, that was the other thing they said last night. So the bottleneck is not going to be Nvidia chips, but probably at this point, but other arenas. And that's where some of that money's going.

[Unknown Male Commentator]

And where would you try to play if it doesn't work? Andrew, the Journal points out that bears are. They're doing Amazon and Alphabet. They're not doing Nvidia. They're supposed to come up with a combined 670 billion to build out just their AI infrastructure. So is that overdone for those two? Can they. They got it, don't they? I mean, Metaz Alphabet's results?

[Andrew Ross Sorkin]

No, they need to.

[Unknown Male Commentator]

They're out of control too, and they need to do it. But they got the money too, don't they?

[Andrew Ross Sorkin]

And they have the money. It's a different story, but that's a different question about. Than the rest of the whole business. We'll see.

[Unknown Male Commentator]

Netflix co CEO Ted Sarandos is reportedly heading to the White House for meetings today. A Politico report says Sarandos will be talking about his company's bid for Warner Brothers discovery, obviously. And President Trump's call Netflix to fire board member Susan Rice. But it's unclear if Sarandos will meet with President Trump himself. Netflix declined to comment on the report. And the White House says it's not going to provide information or discuss private meetings that may or may not be happening at the White House.

[Andrew Ross Sorkin]

The Pentagon potentially laying some groundwork for a move against Anthropic. Axio is now reporting the Defense Department also asking Boeing and Lockheed Martin yesterday about the company's exposure to Anthropic's AI model Clawed. That could be an indication that officials are getting ready to label Anthropic a supply chain risk. The Pentagon putting pressure on Anthropic to let the government use the company's technology for what they're saying is any lawful purpose it wants. Anthropic has pushed back on that broad access. And sources tell CNBC that Defense Secretary Pete Hegseth gave Anthropic until tomorrow afternoon to provide wide access to its technology before the government could label Anthropic a supply chain risk or invoke the Defense Production Act. So here we are in a standoff that is actually, I think, a much bigger deal than maybe we're even giving

[Unknown Male Commentator]

it credit for because it involves so many things.

[Andrew Ross Sorkin]

But this was the one.

[Unknown Male Commentator]

You say the word hegseth and it involves.

[Andrew Ross Sorkin]

No, no, to me, it's not even about politics. It's about the idea that Claude and Anthropic in particular, they've been the most worried about safety of all of the companies. They seem to have this week. We talked about it earlier this week, sort of, you know, lessened some of their views.

[Unknown Male Commentator]

They gave valid service to it, but were acted differently.

[Andrew Ross Sorkin]

Well, I. No, no, no. So there, there's two things going on. There's the safety issue just about like how safe is Claude, how safe are all these models? And the fact is that they're actually, they're lessening that in their sort of their safety bridge to become more competitive, to be more competitive at the same time that they're saying that this stuff could still be used in really bad ways. And so here we are.

[Becky Quick]

I do think it's a serious concern that Dario Modi has had over this time. And by the way, we talked to Jensen Huang about this, too. We'll play that a little later. Just bringing this up because Anthropic is a huge client.

[Andrew Ross Sorkin]

And customer.

[Becky Quick]

And customer.

[Andrew Ross Sorkin]

And where does he Land. Can you give us a little hint?

[Becky Quick]

I asked him.

[Jensen Huang]

The Defense Department has the right to use the technology and use products that they procure in the way that serves their needs. And obviously their needs are dependent on war. In the case of Anthropic, of course they have the right to decide how they would like to market their products and what kind of use cases it could be used for. And so I think they both have their reasonable perspective. And however it gets worked out, this won't be. The Anthropic is not the only AI company in the world. And of course United States is not the only customer for any company in the world. And so I think they both have their proper positions. I hope that they can work it out. But if it doesn't get worked out, it's also not the end of the world.

[Unknown Male Commentator]

I don't think we're agentic threat. I don't think it's a threat to us because we.

[Andrew Ross Sorkin]

Why not? Because we have.

[Unknown Male Commentator]

Because it's garbage in, garbage out, and

[Andrew Ross Sorkin]

we have perfected our garbage.

[Becky Quick]

Oh, you mean to us as anchors?

[Unknown Male Commentator]

Yeah.

[Becky Quick]

Oh, I thought.

[Andrew Ross Sorkin]

But I think it is a. It's a genuine threat to us.

[Unknown Male Commentator]

You can't. They don't. They don't have general.

[Andrew Ross Sorkin]

Yes, I see that too.

[Unknown Male Commentator]

Even you.

[Andrew Ross Sorkin]

Even you.

[Unknown Male Commentator]

Even you have perfected.

[Becky Quick]

I like how you each say even you.

[Unknown Male Commentator]

No, even you have perfected.

[Andrew Ross Sorkin]

Well, Becky's obviously safe, but.

[Unknown Male Commentator]

She's safe. But even you are essential. You're essential. You need key man insurance if you want.

[Becky Quick]

I think Andrew's talking about concerns about humanity.

[Andrew Ross Sorkin]

I'm saying there's. I'm talking about humanity. I'm talking about robots that are controlled by Claude and drones. All right?

[Unknown Male Commentator]

They're not going to be sitting here

[Andrew Ross Sorkin]

the way the government anytime soon can use these things and can use these things either inappropriately on their own or use these things inappropriately without even knowing.

[Unknown Male Commentator]

You said earlier agentiq was gonna replace us. That's what I'm still for.

[Andrew Ross Sorkin]

You're still back on that?

[Unknown Male Commentator]

Yeah, I'm still back on that.

[Andrew Ross Sorkin]

Always. Always thinking of, you know.

[Unknown Male Commentator]

Right, Enough about me. Let's talk about me.

[Andrew Ross Sorkin]

Focus on number one. Tease'll be next.

[Joe Kernan]

Coming up on Squawkpod, FDA Commissioner Dr. Marty Makari, the internal politics at the FDA and the number of medical reforms he's been pushing forward just 10 months on the job.

[Dr. Marty Makary]

We've advocated for many more reforms in the 10 months that I've been at FDA, we advocated for the renewal of the pediatric priority voucher program that gives companies 100 to $200 million in the form of a transferable voucher if their rare disease drug is approved. Rare diseases is the vast majority of the resources in our drug effort. It is now the majority of drugs that we approve are for rare diseases.

[Joe Kernan]

We're back after this break.

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[Dr. Marty Makary]

N why have I asked my electrician

[Andrew Ross Sorkin]

I found on Angie.com to bury my pet hamster? I was so moved by how carefully

[Dr. Marty Makary]

he buried my electrical wires, I knew

[Andrew Ross Sorkin]

I could trust him to bury my

[Dr. Marty Makary]

sweet nibbles after his untimely end.

[Unknown Male Commentator]

This is very strange, Angie.

[Dr. Marty Makary]

The one you trust. Define the ones you trust. Find pros for all your home [e-mail]

[Joe Kernan]

welcome back to Squawk Pod. Here's Becky Quick.

[Becky Quick]

The FDA has released a framework to accelerate the development of therapies for rare diseases. Joining us right now is FDA Commissioner Dr. Marty Makary. And, commissioner, thank you for being with us today. This was big news earlier this week when you put out this new framework the FDA is going to be working on. And I think you phrased it best when you said rare isn't really all that rare at all. Rare diseases impact about 30 million Americans. But the system that we have set up right now to approve any sort of medications, therapies that might assist with that is really set up for ailments that affect much larger populations. What are you doing with these new requirements that you're laying out?

[Dr. Marty Makary]

Well, Good morning. And you're exactly right, Becky. The system has been set up for common diseases and not rare diseases. For example, the requirements to do randomized controlled trials when these populations are very small. And I want to thank you personally for your passion on this topic. We need to generate more awareness. I personally am very passionate about this topic, having taken care of hundreds of individuals with rare diseases in my career at Johns Hopkins. That's typically where people would go to tertiary medical centers. And when you take care of these people and you break bad news and you say, hey, there's nothing out there that we know of that can be used as a therapeutic, it has an impact on your soul and your thinking. And so I bring a sense of urgency and a sense of we've got to do something about this community to my role at the agency. As you said, about 1 in 11Americans has a rare disease. Now, the FDA in the past historically had treated therapeutics for rare diseases like an afterthought. But today we have tax credits, waivers of the two to $4 million application fees, extended market exclusivity, and we've got a new rare disease innovation hub to train the reviewers on standardized approaches. And we've advocated for many more reforms. In the 10 months that I've been at FDA, we advocated for the renewal of the Pediatric Priority Voucher program that gives companies 100 to $200 million in the form of a transferable voucher if their rare disease drug is approved. Rare diseases is the vast majority of the resources in our drug effort. It is now the majority of drugs that we approve are for rare diseases. And President Trump signed that voucher program into law three weeks ago. We also announced at JPM that we're going to have more regulatory flexibilities with manufacturing requirements. You don't have to routinely run three batches of a product. When a scientist in a lab develops a new gene therapy for a baby like baby kj, we're going to use Bayesian statistics that looks at all the trials, all the data in the world, not just looking at a trial in isolation. And of course, we publish in the New England Journal of Medicine and announced on Monday our plausible mechanism pathway. We want to see more baby KJs. If there's a mechanism that makes sense, we wave all the clinical trial requirements and we say, if this is safe and looks like it works for an ultra rare disease, we're going to go ahead and green light that therapy.

[Becky Quick]

Marty, I love all of these things that you're laying out. I think it's incredibly Important. We just did a story yesterday about baby KJ for anybody who wasn't watching. He was a baby who was treated at Children's Hospital of Philadelphia with a genetic therapy, the first of its kind. And it looks like he's doing very well and huge props for what you are doing. I will also say investors that I've spoken with will say these are great moves for ultra rare in particular, but there are concerns about slightly less rare diseases and some of the things that have been happening there. This was laid out yesterday in a Wall Street Journal opinion piece or editorial where they raised questions about what you were doing, which looks like it's great for rare disease. But then at the same time, Dr. Vinay Prasad at the FDA has been quietly, they say, undermining the program by, you know, turning down, with a crl, a complete review letter that turns down some of the things for these companies that are working on rare diseases where they had been following the advice of the FDA from earlier. And it looks like they're changing the rules of the game later. How do you respond to that?

[Dr. Marty Makary]

Well, first of all, Becky, there's always going to be two sides to a story. You know, imagine in a theoretical, I know this has never happened to you, but if you have a dispute with your spouse and you go to a captive audience, you're always going to give one side of the story. And so we decided at the FDA that if we reject a drug, the public deserves to know why. So for the first time in history, our letters detailing why a drug has not been accepted, detailing that we gave guidance that was not followed, detailing why the clinical trial showed no benefit, that is now public information in real time. So I think there has been a bit of an effort to find a bogeyman to account for certain products that were not approved. For example, there was a product where the researchers drilled a burr hole, literally a hole in people's skulls, to inject intrathecally into the ventricle, a therapy. The randomized control trial at the end of the randomization period is found no benefit. And yet this is one of the drugs that we were pressured to approve. Now, look, I have a lot of sympathy for those patients. There's nothing out there to offer them. But we're not going to go ahead and approve something like that that has morbidity associated with it. If the clinical trial was stone cold normal, the process is pretty simple. If your drug works, it's going to get approved by the fda. And let's just remember, there are moneyed interests. I Get it. If I were an investor and I put in $100 million into a a product and you didn't get the results that you liked, it is disappointing. But there has been sort of this effort to put a fatwa on Vinay Prasad by one or two media outlets as if he's the one who's making these decisions. One of them was not even in his center cited in that article.

[Unknown Male Commentator]

Dr. What's he doing in the Trump administration in the first place? He couldn't be confirmed by the Senate most likely because he's such an ardent supporter of Bernie Sanders government run health care. So what is the upside or the what do you see in him to leave him in the position of to head up your biologics unit?

[Dr. Marty Makary]

Well Joe, that's part of the smear campaign. I'm picking the best scientist. Vinay Prasad loves President Trump. He did support Bernie Sanders in the past, but he saw the incredible revolution with President Trump and is an ardent supporter of President Trump. Just listen to his podcast for this doctor well if you listen to his podcast for the last four years, years, you'll see that he has been an ardent supporter of everything President Trump has done and is trying to do. We pick people based on the best scientific minds. When you have a surgeon, you want the best surgeon out there. Vinaya Prasad is a genius. He's on loan from UCSF. He's published over 500 scientific peer reviewed articles and some of the drugs are criticizing him for that got rejected. Either had stone cold normal trial results or he wasn't even involved. His center, the Biologics center has had a record number of approvals that it hit in December. And so we're getting stuff done. The system works. If your drug works, it's going to get approved. And if not, the public deserves to know why we're putting those decisions out there. And final point I'll say is that 100% of the accept or reject decisions that the FDA on my watch have been the accept or reject recommendation of the primary career scientists at the agency. So I stand by our scientists and, and again we put the information out there so it's public. We're meeting 100% of our PDUFA dates for the first time in history and we're getting decisions out now in a matter of weeks. We have a decision coming out today on a powerful new drug for a type of cancer and it is going to a response rate double of what's out there. We got that decision out 44 days after the new filing period because of our new National Priority Review program. We want to take that review period down from a year down to a number of weeks. And so we're getting that done and we're going to get more done. And of course you may have seen that we have announced we're going from a requirement of two clinical trials down to one. And that alone is going to allow companies to put twice as many drugs through the process.

[Becky Quick]

Yeah. And Marty, again, kudos on all of these moves that you're talking about. I agree with all of it. But I do want to come back to one point that the journal made about Dr. Prasad and this is what he's written about in the past. This is what he has certainly been vocal about. They say he seems to believe the cost for drugs that receive accelerated approval exceed their benefits and that nothing short of a large double blind randomized controlled trials should be sufficient to prove a medicine's efficacy. You and I have talked about this before. The idea that in rare disease it's really difficult to do a large double blind randomized control trial. First of all, you don't have enough patients who you can find to do this. And secondly, most institutions won't do these things, particularly if it's for a life threatening disease, because it's unethical to insist on a blind trial where some people get a placebo if the end result is they die without it. Do you agree with that theory? Do you think that there should be double blind randomized trials for rare diseases that have life threatening consequences?

[Dr. Marty Makary]

Look, no, we don't. And Dr. Prasad really has never championed that idea. So that's part of a smear campaign. Again, we've seen a fatwa put on him by one or two media outlets, investors.

[Becky Quick]

It's not just Marty, it's not just one or two media outlets. It's investors who I've spoken with. It is companies who I've spoken with. This is the most common complaint I get from anybody I talk to in the industry. It's from researchers.

[Dr. Marty Makary]

Yeah. So look, if a clinical trial shows no benefit in a randomized trial, then it's not going to get approved. But we have a record number of approvals under Dr. Prasad. He authored the plausible mechanism pathway to have more baby KJs. He authored Going from Two to One Clinical Trials for common diseases. And he was part of the national priority review voucher program to get decisions out in weeks instead of a year. So we do not believe that you have to use a randomized control trial model for all rare diseases. We believe in regulatory flexibilities. And that's why we very clear. So the system is very clear. We give guidance. If the guidance is followed, then there's a clear path to approval. But if the trial shows no benefit and harm, then, you know, there are two sides to that story. And that's why our decision letters are public.

[Unknown Male Commentator]

Dr. Another day, another, another op ed piece in the Wall Street Journal. I hope that's not the media organization that you're saying is smearing people. That might be one of the few places I ever feel like I find some balance or objectivity. I know they've been tough on the president about certain things, but now the latest is on the nominee for surgeon general. And again, she founded a wellness business. Casey Means did. Their criticism is she had a chance to dispute claims linking vaccines with autism. And she said, well, we don't really know. And there's been so many studies that, I mean, obviously we don't know, but it doesn't appear to be related to vaccines at this point. Is she the best person? The Journal says what HHS needs are serious people who will tell the truth and begin to restore confidence. Not, I guess, kind of someone that will agree with RFK Jr on a lot of the vaccine, you know, controversies.

[Dr. Marty Makary]

Well, look, I didn't think that was a fair piece. Casey Means has been pretty clear. She believes that the best way to prevent measles and other vaccine preventable illnesses are through vaccination. And so she's told me, you know, the measles outbreaks that we've seen that predated rfk, people want to peg it to him. But these are folks that didn't get vaccinated five, six years ago that are getting it today. And it's a global outbreak. That's not because of rfk. She has told me this is a good reminder as to why people need to get the measles vaccine. So, look, you're going to see different spin out there. You're going to see it on, you know, different folks based on moneyed interests, based on partisanship. Kasey Means is the best person for the job. Let me tell you why. She is a surgical specialist who saw the futility in going down this road of just operating and medicating on diseases and wanted to get into food as medicine and talk about school lunches and holistic care and insulin resistance and general body inflammation. And she talks about the microbiome and, and the importance of natural light exposure for kids instead of just medicating them for depression at scale. We need fresh new ideas in health care. And she's the perfect person for that,

[Unknown Male Commentator]

right for processed foods and everything else. And I want to just thank you for you knew you were going to be hearing about this stuff, I'm sure today. And you're a great spokesperson and we appreciate you facing questions like, like, like these.

[Dr. Marty Makary]

Dr. Yeah, thanks so much.

[Becky Quick]

No, Commissioner McCary, thank you. And especially thank you for what you're rolling out with rare disease. It's something I'm very focused on and we do appreciate your coming on to talk about it.

[Dr. Marty Makary]

Thanks for, thanks for your work on this, Becky. And you're going to see some amazing announcements from the FDA in the next couple of weeks. Decisions out in weeks instead of the standard year. This is going to be a record number of year, a record number of approvals this year. We're already above our record for 5 and 20 year averages. And you're going to see more coming out very shortly. We're at 100% compliance with our target dates. So I'm happy to report the FDA is strong and it's going to continue to be strong.

[Becky Quick]

Dr. Makary, thank you. We look forward to talking to you again soon.

[Joe Kernan]

Next on Squawk Pod, producing the most followed person on the Internet. Mr. Beast. Beast Games Season 2 on Amazon prime just ended, but for beast Industries season CEO Jeff Housenbold, the bigger picture is just beginning.

[Jeff Housenbold]

Mr. Beast is akin to Mickey Mouse, very important character. But they have Lucas and Star wars and Marvel and Avengers and Pixar and Woody. And so what you'll see over time is we're moving away from an individual to building an entertainment platform that will allow for other content and other talent.

[Joe Kernan]

The characters coming and the Couchy controversy brewing right after this.

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[Dr. Marty Makary]

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[Joe Kernan]

This is Squawk Pod.

[Andrew Ross Sorkin]

You're watching Squawk Box on cnbc. I'm Andrew Ossorkin along with Joe Kernan and Becky Quick. A moment. Last night from the season finale of Beast Games.

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[Unknown Male Commentator]

Thank you so much for watch watching this show.

[Jeff Housenbold]

I can't wait to see what you think of season three. I'll see you there.

[Andrew Ross Sorkin]

Joining us right now, exclusive interview to talk about the season so much more. Beast Industries president and CEO Jeff Heisenberg. Good morning to you.

[Jeff Housenbold]

Good to see you again.

[Andrew Ross Sorkin]

So this is a big deal. We should say he's the most followed. Continues to be the most followed individual on social media. 468 million subscribers on YouTube now.

[Jeff Housenbold]

On YouTube. Yep. And over a billion across our platforms, by the way.

[Andrew Ross Sorkin]

How much more before we even get anything else, how much more can that grow?

[Jeff Housenbold]

There's seven more billion people to get.

[Becky Quick]

I like how you think.

[Andrew Ross Sorkin]

Is there how many more people are actually on the platforms though?

[Jeff Housenbold]

About 2.8 billion. More.

[Andrew Ross Sorkin]

About 2.8 billion. I'm sure you've looked to figure out, like what percentage of the people who are on platforms are touching him in one way or the other.

[Jeff Housenbold]

It's incredible. In the last 90 days alone, 1.54 or 5 billion unique people around the world have watched our content. 80% of those outside the United States. Jimmy is a global phenomenon.

[Andrew Ross Sorkin]

So how much does this show on Amazon change that balance and how do you think about that versus these other platforms?

[Jeff Housenbold]

First, we want to meet our audiences where they are. So regardless if they're on YouTube or Instagram or TikTok, Amazon Prime, Netflix, we want to create content across multiple platforms to meet the consumer where they are. And each One of those platforms have a strength in terms of format, in terms of content, in terms of demographic. And so, for example, Beast Games ages up and tilts more female than our YouTube audience. So it's good for us and it gives our advertising partners more breadth and reach long term.

[Andrew Ross Sorkin]

We've talked about this a little bit. I mean, Jimmy is the center of the whole universe. But do you want to try to create. Create other characters, if you will, inside the Beast world? And I'm thinking actually about the winner of Beast Games. We were talking about the winner of the first season and whether some of these kind of people or maybe others sort of turn into sort of Beast. Beast like characters almost in this universe.

[Jeff Housenbold]

Yeah, no, it's the right insight. If you think about Jimmy Donaldson, he's akin to Walt Disney, a brilliant storyteller using the medium of his time to create content that engages, inspires and entertains. And Mr. Beast is akin to Mickey Mouse, very important character. But they have Lucas and Star wars and Marvel and Avengers and Pixar and Woody. And so what you'll see over time is we're moving away from an individual to building an entertainment platform that will allow for other content and other talent to emerge and rise as a star.

[Andrew Ross Sorkin]

I want to ask you about something that's in the news because it's fascinating and maybe you have a take on it, because I think a lot of executives are thinking about this now. This is the prediction market situation that you felt you sort of fell into, which is there's reports that an editor that worked for Beast Industries was suspended from using the KALSI platform because they effectively were betting on things that they knew were happening inside the Beast world. This is like a whole. We're like living in a whole new universe now.

[Jeff Housenbold]

The whole prediction markets are a new phenomenon that are rising. And I think corporations, individuals, federal and state regulators are all grappling with. We saw this coming. And so a couple months ago, I put in place policies for all of our contestants in Beast Games season two and three for our employees to make them aware that we don't want anyone to trade on information, regardless of what the current ambiguities around the law. Is this gambling or not? So we put that in place three

[Becky Quick]

months ago before this happened.

[Jeff Housenbold]

Before this happened. We found out yesterday when it hit the press, we conducted with our chief compliance officer a quick investigation. We put the employee on suspension while we complete that investigation.

[Andrew Ross Sorkin]

So, but this is the big question, which is there's going to be employees, there's going to be Contestants potentially in some of these things. But there's also, I imagine, you know, if Jimmy's out in Africa or something, I don't know. And somebody knows that he's there and someone could bet that he's there or not. Or people who are not even attached to the business, who are somehow aware of, see something, understand it and what you think the rules should be about the same other. This is not just a, this is not a beast industries issue. This is like a, this is like an everybody issue.

[Becky Quick]

Jeff, kudos on thinking ahead and getting to that point because when we've had, you know, people who have come on from the industry, our point has been it's not your job to police this stuff. I think you were pretty prescient in realizing that and getting ahead of the curve.

[Jeff Housenbold]

Thanks. And I watched your segment with the CEO of Kalsha a couple days ago and your insights I thought were exactly right. The prediction markets are going to have to self police, but I don't think that's sufficient. Right. We're going to need to decide as 20 state AGs are wrestling with this today. Is this a gambling state regulatory framework? And I was on Caesar's board so I know a lot about gambling looks like gambling. Right. And then the wrestling with the feds who want to mandate it. The government's going to need to figure that out. The private sector is going to need to self police themselves and the prediction markets are going to need to put policies in place. But it is ripe for abuse and our concern is to protect the little people right from that. Just like the casino companies have to do.

[Andrew Ross Sorkin]

Do you think it's, I mean just given now your experience of seeing all this, do you think it's much more widespread than we know? Meaning that there are people all over that are making money in ways that we don't. I mean it doesn't get. We talk about it all the time but we don't really talk about like who's actually making the money and are there. Do you think there's employees of all sorts of to companies that are just doing this on the side and nobody really knows what's happening 100%.

[Jeff Housenbold]

It's not just employees. You could be a third party cameraman on set and know what the first song in the rehearsal is for a singer. You can be the person reviewing a script and knowing what the end result is. So there's so much information out there and it's asymmetric and people are taking advantage of that.

[Andrew Ross Sorkin]

While we have you here, tell us About a couple other things. You're getting into the, the banking business, the fintech business basically in a big way. And I don't even know if our audience knows that about what you're up to.

[Jeff Housenbold]

We're so excited. A couple of weeks ago we announced the acquisition of Step, which was a six year old fintech business founded by Alexi and CJ and their mission was to help educate people around financial services, around budgeting, around credit, around responsibility, particularly young people establishing credit and getting started. And it fits so perfect with our mission which is to up level children around the world. And so we're coming together and using Jimmy's reach, our fandom of Gen Z and Gen Alpha and what we want to do. As Jimmy said in his recent tweet, he said, I grew up without any of this knowledge. I wish I had it, I want to provide it to others. I grew up on welfare and food stamps and felt the same exact way. So what we're going to do is take what is traditionally dry information around financial literacy. We're going to make it entertaining, we're going to gamify it and we're going to help drive the habits that lead to long term success for the masses.

[Andrew Ross Sorkin]

We love that. What are the economics of that?

[Jeff Housenbold]

Traditional fintech, right. Checking and savings accounts, not really profitable. It's the base business. Then you have secured and unsecured credit cards, you have personal loans, student loans, mortgages, insurance and brokerage. And so each one of those businesses have a different profit margin. But the real key is to develop a lifetime relationship with the customer so as they grow and their personal wealth grows, you're able to capture some of that margin.

[Andrew Ross Sorkin]

You're involved in Bitmine.

[Jeff Housenbold]

Bit Mine is involved with us through an investment into Beast Industries.

[Andrew Ross Sorkin]

Into Beast Industries. So they're invested in you as opposed to you being invested in them. But I assume you care about the future of Bitmine, therefore.

[Jeff Housenbold]

I do. Bit Mine is a leader in the Ethereum staking market. And if you think about stablecoin and the ability to provide a lower cost of capital and pass that on to the consumer. Ethereum is the backbone of Stablecoin and the blockchain. And so we're big fans of Ethereum. We think the Defi movement is really important and the benefits that it brings consumers in greater access, democratization, lower cost of capital, the ability to move capital around the world in a safe and secure way.

[Andrew Ross Sorkin]

Long term, how many different businesses you think you can be in?

[Jeff Housenbold]

Well, when you have 1.45 billion users, there's a lot of share of wallet that you could gain. Today we're in the media business. We're in the consumer products business with our chocolate and feastables, our toy line, our relationship with Jack links around healthy protein snacks, our lunchly business. And now we're into financial services and moving into telecom communications as well.

[Andrew Ross Sorkin]

Wow. Jeff, thank you. Appreciate it.

[Jeff Housenbold]

Good to see you guys again. Thank you.

[Andrew Ross Sorkin]

And we should, by the way, make a disclosure that CNBC and Kalshi have a commercial relationship given that we were just talking about Kalshi and what's going on in the prediction market space. Thank you.

[Joe Kernan]

That's Squawk Pod for today. Thanks for listening. Squawk Box is hosted by Joe Kernan, Becky Quick and Andrew Ross Sorkin 2. Tune in weekday mornings on CNBC at 6 Eastern to get the smartest takes and analysis from our TV show right into your ears. Follow Squawkpod wherever you get your podcasts. We'll meet you back here tomorrow.

[Andrew Ross Sorkin]

We are clear.

[Jeff Housenbold]

Thanks guys.

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