BN

MAGA MAHA against BigPharma but, support RFK JR with all my heart

[IBRX @IBRXBiz]

$IBRX Mark your calendars: Russell reconstitution is June 26th. With a market cap now north of $8B, IBRX is set to move up to the Russell 1000 mid-cap index. That triggers mandatory buying from institutional funds that track the index.#ANKTIVA

[BN @BNegusei]

$IBRX amazing

[Freedom @ActionFixesFear]

$IBRX An elephant should be a cancer factory. It carries roughly a hundred times more cells than you do and can live past seventy, and any one of those cells can turn cancerous. By the raw math it should be dead of a tumor long before it ever grows up. Instead, elephants get cancer far less often than a body that size has any right to. When scientists finally found the reason, it was almost funny: where you carry a single copy of the master gene that catches a cell turning traitor, an elephant carries twenty. Evolution didn't make it cancer-proof. It just gave it more guards.

You can't bolt twenty copies of a gene into a person. But each of us is born with our own set of living guards: the immune system. Its job is to find the one cell that has turned traitor - hiding in plain sight among tens of trillions of healthy ones - mark it, and send in the killers before it spreads. When it works, you never even know you had cancer.

Find it, mark it, kill it. That is the entire game of beating cancer.

For all of history, the only thing that ever played that game was the immune system you were born with. That is changing now. A race is on to build the hunt on purpose - to find, mark, and kill cancer on command - and two very different contenders have entered it. One the whole world is watching: the most powerful companies on earth, now turning their AI loose on biology. One almost no one is: a lone doctor who has spent the better part of two decades quietly assembling the entire machine - and who, just this week, reached for that same AI himself.

THE PLAYERS NOBODY EXPECTED

Start with the ones nobody expected to see in a cancer fight at all: the architects of the artificial intelligence now reshaping the world. You already know this AI - it drafts our emails, does our kids' homework, and can pass the licensing exam a doctor takes. The people who built it have spent more than a decade quietly deciding that biology is the real prize. And lately, they have thrown everything at it. Once you see what they are aiming all that intelligence at, and the one thing not one of them has, you can't unsee it.

And that one thing is the strange heart of this whole story. Everyone assumes the trillion-dollar AI companies will take cancer the way they took search and chat: biggest models, deepest pockets, game over. But there is one piece of this they cannot code - and cannot buy in a hurry. So let's lay the board out the way it actually sits.

WHAT'S SETTLED, AND WHAT'S STILL A RACE

You may already know the shape of the problem. The immune system runs two guards: T cells kill any cell flashing a cancerous ID badge; NK cells kill any cell that hides its badge to dodge the first guard. Between them, almost nothing should survive. And yet a few cancer cells learn to evade both at once - and slip through. They go quiet, wait, and months or years later grow back. That is a major route to recurrence: not new cancer, but survivors of the first fight coming back changed. Anyone who has watched a "clear" scan turn back into a diagnosis knows it is the cruelest part of the disease.

That part is settled. The part still up for grabs is the targeting: a third way to mark the cell that got away - one that does not depend on the badge at all - so a killer can find it no matter how it is disguised.

THEY ALL POINTED AT THE SAME BATTLEFIELD

Ask the people building the world's most powerful AI where they would put their money, and they keep naming the same place.

Demis Hassabis, who just won a Nobel Prize for AI, says we may "cure all disease" within a decade.

Jensen Huang of NVIDIA: for the first time in history, "biology has the opportunity to be engineering, not science."

Bill Gates: if he were starting out today, one of his three fields would be the biosciences.

Mark Zuckerberg is pointing the bulk of a 200-billion-dollar philanthropy at "AI-powered biology."

And Dario Amodei, the CEO of Anthropic, asked point-blank for a single stock to pick, refused to name a company - and named the industry instead: biotech, "about to have a renaissance, ultimately driven by AI."

And none of this is new. Google started an anti-aging company back in 2013. Zuckerberg pledged to help cure all disease in 2016. Gates named the biosciences as a field to build a life around in 2017. They have been walking toward this for more than a decade - and in the last two years they broke into a run.

The finest targeting engineers alive have all turned their eyes to the same battlefield: the human body.

THE TARGETING COMPUTER

Here is what they are all racing to build: the perfect targeting computer.

The word "painter" comes from the battlefield. Before a precision strike, someone has to "paint" the target - mark it exactly, usually with a laser - so the weapon knows precisely where to hit. In cancer, the painter is a molecule that latches onto a tumor cell and lights it up: hit this one. Build a better painter, and you can mark targets the body's own guards can't even see.

For sixty years, designing that painter meant trial and error at a lab bench. Then in 2020, Google's AI learned to predict the exact three-dimensional shape of a protein - the folded origami knot that decides what a molecule does and what can grab onto it. A puzzle biologists had chased for half a century, cracked almost overnight. The AI had learned to see the lock. And once you can see the lock, you can design the key - the painter - on a screen, before you ever touch a test tube.

That is what these giants are pouring billions into: a machine that designs better and better painters - precise molecules built to hit any target they are aimed at. The most precise targeting computer in the history of medicine.

But staggering as it is, a targeting computer has one fatal limit.

WHAT A PERFECT PAINTER CAN DO ALONE

Nothing.

A mark on a tumor is just a mark until something in the field answers it. You need a strike force on the ground that will act on the paint. And you need clearance - permission to run the mission inside a living human being, not just war-game it on a screen.

The AI giants have built the most beautiful designators ever made, and own no strike force. Not one of them has ever been cleared. Add up Google, OpenAI, NVIDIA, Anthropic, Meta - and the number of medicines they have gotten approved and into a patient is zero. They paint. Then they hand the coordinates to someone else.

THE HALF EVERYONE SKIPS

Painting is the part that photographs well. The strike force is the part that takes most of a career and breaks most people.

Because answering a painted target inside a living body is brutally hard. You need killer cells that will actually go where they are marked. You need to keep them awake inside a tumor engineered to put them to sleep. You need to grow them, manufacture them, prove they are safe, and convince the FDA to let you put them into a human being.

That is the unglamorous half. And it is the half @DrPatrick has spent the better part of two decades building, while everyone else stayed busy watching the AI models dazzle.

WHAT THE DOCTOR ACTUALLY HAS

Soon-Shiong owns every part the giants skip. Four pieces, built over twenty years, that lock together into one machine. Here is each, plainly.

The painter: an antibody he calls the Nantibody. An antibody is a Y-shaped protein that clamps onto one target and waves a flag from its tail - the chemical signal for kill this. His borrows a trick from camels and sharks, whose antibodies are a fraction of the size of ours - small enough to reach handholds on a cancer cell that big human antibodies cannot.

The strike force: natural killer cells, the same second guard from before, engineered to carry an extra-strong version of their natural grabbing receptor, CD16, which locks onto the painted flag and destroys the cell wearing it. His are off-the-shelf, grown from a master line - a standing army, not a unit built one patient at a time.

The fuel: IL-15, the molecule that wakes those killer cells and drives them to multiply inside a tumor built to starve them. It is sold today as the approved drug ANKTIVA.

The clearance: the credential not one of the giants holds. FDA approval, earned not once but twice - the chemotherapy Abraxane two decades ago, and ANKTIVA today.

And then, this week, he reached for the fifth piece - the giants' own weapon. He says he has begun turning AI modelling onto his painter. "The next evolution of antibody drug development is happening," he wrote, and "what I see together with AI modelling is stunning."

Be honest about that line. "Stunning" is his word, not a result - no molecule, no data, no product yet. He is reaching for the giants' AI, not claiming he has out-built them at it. But sit with the shape of it: the one man already holding the painter, the strike force, the fuel and the clearance is now reaching for the targeting computer too.

THE WHOLE STRIKE, IN PLAIN ENGLISH

Now watch the pieces run as one operation.

A cancer cell has slipped both guards and gone into hiding. The AI studies it and designs a painter sharp enough to find it - the part the giants do better than anyone alive. The painter slips in and lights the hidden cell up: hit this one. The strike force - the killer cells, already on the shelf, no weeks lost building them for a single patient - reads the paint, closes in, and destroys it. The fuel keeps them awake and multiplying, so they run down every last cell that tried to slip away: the cells that, left alone, come back months or years later as recurrence.

Most of this machine is still being proven in trials - but the fuel that powers it, ANKTIVA, is already FDA-approved and in patients today. So this is not a war-game on a screen. It is a strike with at least one piece already cleared to run inside a living human being - which is one more than every trillion-dollar lab in this race can claim.

That is the whole machine: design the paint, mark the target, send in the strike, keep it fueled - and, the part no one else can do, carry it all the way into a patient.

WHAT THE ANTHROPIC CEO ACTUALLY POINTED AT

Remember Dario Amodei, the Anthropic CEO who would not name a single company and pointed at biotech instead? Watch what he named when they pushed him on which part. Not an AI model. A cell therapy - CAR-T, "where you genetically engineer cells" to hunt cancer.

Sit with that. The CEO of an AI lab, asked to make a bet, pointed at engineered killer cells. The strike force. The exact layer his own company does not build.

CAR-T works - there are approved CAR-T drugs. But its strike force has to be hand-built for one patient at a time: you harvest that person's own cells, re-engineer them, grow them, and put them back, over weeks, for around half a million dollars - and it can turn friendly fire on the body it is meant to defend. The NK strike force Soon-Shiong is building is the off-the-shelf answer to all three: a standing army instead of a bespoke unit, ready on the shelf, designed to answer the paint without the friendly fire.

The honest caveat, because we always give it: that standing army is newer and less battle-tested than CAR-T. It is the more scalable approach, not yet the more decorated one, and it is still investigational. But the direction is exactly where an AI titan just pointed.

THE BOARD IS NOT EVEN

Let's not pretend it is. The giants have tens of billions and the best minds money can hire. Soon-Shiong has a small fraction of that, and plenty of people who have written him off.

On money, it is not close - the giants win it walking away. But on the one thing money cannot quickly buy - a cancer medicine that is actually approved and reaching patients today - he wins just as easily.

THE STANDOFF

So here is where it actually stands. The trillion-dollar AI giants have built the finest targeting computers ever made - and have no one to run the mission. Soon-Shiong has the whole operation - painter, strike force, fuel, clearance - and is now reaching for their targeting tech too.

Which leaves the question almost nobody is asking yet: do the giants race him, or hand him the targeting computer for the mission they could never run themselves?

Genius was never the bottleneck, and models do not save lives - action does. And the man with the least money in this race is the only one who has already done the thing that counts: he has gotten a medicine to a patient.

Evolution handed the elephant its extra guards the slow way, over countless generations. This is the first time we have tried to build ours on purpose - in a single lifetime, by hand.

Everyone is learning to paint.

One man can paint and run the strike.

[Bullish @bullishbruk]

Let us never forget: ANKTIVA is the ONLY drug that has fully cleared the spike protein — completely. Dr. Patrick Soon-Shiong offered it to the FDA for FREE, and they refused.
Think about that. Lives on the line, a proven solution on the table, and bureaucracy said no.
This is exactly why we fight for faster access, real FDA reform, and putting patients before politics. ANKTIVA Army — keep shining the light. @LoriMills4CA42 @DrPatrick

[BN @BNegusei]

@barak_miles @bullishbruk I don’t know if you know this but, patient testimony, especially unscripted and heartfelt accounts like Lori Mills’, has a proven, powerful impact on drug development, regulatory decisions, and public awareness than a “Tom Cruise” like performance.

[BN @BNegusei]

@adamfeuerstein I genuinely don’t understand why you’re defending a convicted criminal. Are you trying to tell us something about yourself we should know?

[BN @BNegusei]

Avoid @kacdnnp91
This DNP (not an MD) pushes unproven, non-FDA-approved supplements & “treatments” as a rebel healer.
She’s a snake oil salesman: main goal is profit, not curing people. Misleads with “tyranny vs rebels” rhetoric & false hope to sell expensive unproven junk.
#MAHA

[Bullish @bullishbruk]

$IBRX @kacdnp91 Warning: Avoid “Kelly DNP Functional/Integrative Medicine” (@kacdnnp91)
This account promotes “functional/integrative” treatments, supplements, and protocols that are not FDA-approved for the conditions claimed.
Key concerns:
• Treatments often lack strong clinical evidence and can delay proven care, cause harm, or waste money.
• She is a DNP (nurse practitioner), not a medical doctor.
• Heavy “rebel vs. tyranny” messaging and anti-mainstream narratives are common red flags in unproven alternative health circles.
Advice: Consult licensed physicians and stick to evidence-based, FDA-approved treatments. Always verify claims with reliable medical sources before trying anything promoted as “healing” outside standard medicine.
Protect your health — prioritize science over emotional appeals. $IBRX

[BN @BNegusei]

@kacdnp91 @MAHA_Action Avoid @kacdnnp91
This DNP (not an MD) pushes unproven, non-FDA-approved supplements & “treatments” as a rebel healer.
She’s a snake oil salesman: main goal is profit, not curing people. Misleads with “tyranny vs rebels” rhetoric & false hope to sell expensive unproven junk. 🚫

[BN @BNegusei]

@FDAOncology FDA Oncology is one of its most captured divisions — reviewers too aligned with Big Pharma over patients. Swap them for unbiased AI and proven therapies like ANKTIVA would’ve been approved already.

[BN @BNegusei]

@oshea9_harry Remember what I commented when you posted “RTF” and it turns out that your info wasn’t true and knowingly or unknowingly you assumed wrong and now it is hard to believe anything you post specially anything about $IBRX

[BN @BNegusei]

@KatyTalento What he did to ANKTIVA was a crime

[Houman David Hemmati, MD, PhD @houmanhemmati]

💊 Today’s publication by FDA of 71 new & revised guidances for the development of high-quality generic drugs can be a game changer for patients.

Why? Oftentimes, it takes YEARS for generics to emerge even after they can legally be available, because the path can be so unclear or complex.

By fixing that (I obviously haven’t read these documents so it’s impossible to know yet comprehensive they are, but I’m hopeful as I know it’s been in the works for some time), there should be much less time for quality generic drugs to become available. And that often translates into better availability & lower cost.

For many conditions, the best drugs (or close enough to best) are already available as generics - you may not hear about them because companies typically don’t advertise generics!

Over time, this kind of patient-focused regulatory action has the potential to make meaningful improvements in how Americans receive care.

[BN @BNegusei]

@stahu73647 @FDAOncology Need to research first because all 5 approved therapies including ANKTIVA was with a single arm none of them was randomized.

[BN @BNegusei]

@FDAOncology

[Moses I. @MBrooks67658]

$IBRX it's insane to issue a 7 month pdufa. There is NOTHING they will know in 7 months that they don't know now. The FDA is still terrible and letting people suffer for their bureaucratic inefficiency. This should have been an immediate "pdufa", since there is literally know reason to wait. the NCCN has spoken, the clinicians have spoken, the data has spoken. What value is there in a stupid 7month pdufa? I challenge anybody to justify that. FDA needs more cleaning-up

[Moses I. @MBrooks67658]

$IBRX it's insane to issue a 7 month pdufa. There is NOTHING they will know in 7 months that they don't know now. The FDA is still terrible and letting people suffer for their bureaucratic inefficiency. This should have been an immediate "pdufa", since there is literally know reason to wait. the NCCN has spoken, the clinicians have spoken, the data has spoken. What value is there in a stupid 7month pdufa? I challenge anybody to justify that. FDA needs more cleaning-up

[Harpoon Harry @oshea9_harry]

Excited about how this turns out. ASCO Immunitybio abstract for GBM

https://t.co/fjd3mUGMug

No new FDA approved treatment for recurrent glioblastoma in over 15 years. So when something new shows real signs of activity, it gets your attention.

Early data from ImmunityBio’s chemo-free immunotherapy combo looks genuinely encouraging. In 14 patients with recurrent GBM, one patient achieved a complete response after just four doses. Half the patients are still on treatment, median overall survival hasn’t been reached yet, and median follow-up is already 6.75 months.

They’re also seeing lymphocyte counts improve and stay up, which is exactly what they’re going after. No CRS or ICANS either.

This is still early stuff, but for this brutal disease any signal like this is worth watching closely.

[Liz Wang @Lizdaretodream]

$IBRX Breaking at #ASCO26: Anktiva + BCG shows 47% complete response at 12 months vs 19% for Keytruda in BCG-unresponsive bladder cancer (nearly 3x better) in matched analysis.

Responses lasted ~10 months longer with a favorable safety trend.

Big win for Anktiva+BCG. Big hope for bladder cancer patients. 👍👍
#IBRX #Anktiva #ASCO26 #BladderCancer

[Wild trading @YYDSxjm]

$IBRX

FDA approval
Japan exclusivity agreement
Dunkirk facility
Leonardo robot
World Bank of NK cells
Acoord Healthcare partnership
27 EU Anktiva approvals
Saudia Arabia Anktiva lung/bladder
Portugal - International center
Middle East hub - Saudia ArabiA
Macau - Chinese gateway
India - BCG production
700% YOY rev increase
380m cash runway (3 to 4 quarters)
Dr Pat holds 67% of O.S.

Feel free to add anything I've missed

[Susan trump @SusanTrumpd]

$IBRX Immunity Bio hits an $8B market cap, solid mid-cap status now! It’s set to join S&P MidCap 400 & Russell Midcap Index, also entering major broad market indices. Forced institutional buying incoming, huge upside ahead within 45 days!

[David McKenzie @mckenzielaw]

Same Clone, Different Code

The FDA's own experts just demolished the regulatory fiction that kept me from my drug.

In March I wrote about what I called the Bladder Preservation Tax — the toll extracted from cancer patients by the distance between settled science and regulatory action. I am a fifty-one-year-old attorney in North Carolina, seven consecutive cystoscopies clear, alive with my bladder intact because of an immunotherapy called Anktiva — the first meaningful improvement to BCG, the intravesical immunotherapy that has been the standard of care for bladder cancer, in nearly fifty years — and a two-month guerrilla campaign against my own insurer to obtain it. I described the insurance denials, the appeals, the Orwellian phone calls, the two-floor elevator ride from the urologist who prescribed the drug to the oncology department that was the only place financially capable of administering it. I described a system that rewards intermediaries for complexity and punishes patients for biology.

On May 18, the FDA held a workshop that proved my case more efficiently than I ever could. On May 19, the agency accepted ImmunityBio's application to approve the drug for patients with my exact disease — and gave itself until January 6, 2027 to decide. I have thoughts about that timeline.

The workshop was titled, with the bureaucratic poetry only a federal agency can muster, "Contemporary Issues in Non-Muscle Invasive Bladder Cancer Trial Design and Interpretation." What it actually was, to anyone paying attention, was the FDA's own invited witnesses testifying against the FDA's own regulatory position. The panelists — thought leaders in the field, the physicians who actually treat this disease — told the agency three things, each more damaging than the last to the distinction the FDA has maintained since Anktiva's original approval in April 2024.

First, they told the FDA that carcinoma in situ and papillary disease arise from the same cancer-inducing clone. They are not two diseases. They are two phenotypic expressions of one disease — CIS being the flat form, papillary being the raised, grape-like form that may simply represent a further growth phase from CIS that was never identified. Same clone. Same biology. Same disease. The regulatory line the FDA has drawn between them is not a scientific boundary. It is an administrative convenience that became an administrative prison for approximately 80,000 Americans diagnosed with papillary bladder cancer each year.

Second, they revealed a statistic that should embarrass every stakeholder in this system: only approximately 6% of urologists in the United States use the blue-light cystoscopy that can reliably detect CIS when it coexists with papillary tumors. Six percent. For two years, insurers across the country have denied thousands of patients coverage based on a diagnostic distinction that 94% of the physicians in the relevant specialty do not have the equipment to make. I was told I had papillary disease "without CIS." The honest clinical statement, according to the FDA's own panelists, is that I had papillary disease without anyone having looked properly for CIS. These are not the same thing. One is a diagnosis. The other is an artifact of underfunded urology practices and a reimbursement system that doesn't pay for the better scope.

Third — and this is the one that should end the debate — the FDA asked its panelists what they actually do when they identify a patient with papillary disease alone. The answer, delivered without hedging, was: we prescribe off-label the therapies the FDA has already approved for CIS and papillary disease. Because the FDA has never approved anything for papillary alone. Several panelists stated that once they find high-grade papillary, they do not even bother to look for CIS, because its presence or absence does not change their treatment decision. The real-world standard of care has already outrun the regulatory framework by two years and counting. The FDA is not being asked to approve something novel. It is being asked to ratify what is already happening at the bedside, in practices across the country, every day — off-label, without reimbursement certainty, and over the objections of insurance companies quoting a billing code distinction that the physicians treating the disease have already abandoned.

The day after that workshop, ImmunityBio announced that the FDA had accepted its supplemental biologics license application for review. The agency assigned a decision deadline — known in regulatory jargon as a PDUFA date — of January 6, 2027. In plain English: the FDA has given itself roughly seven more months. During those seven months, approximately 80,000 more Americans will be diagnosed with papillary NMIBC. The NCCN — a panel of some thirty thought leaders from NCI-designated comprehensive cancer centers — already voted in March 2026 to designate Anktiva plus BCG as a Category 2A guideline for papillary disease alone. The clinical data are published in the New England Journal of Medicine and The Journal of Urology. The three-year numbers from the QUILT-3.032 trial show 96% disease-specific survival, greater than 80% bladder preservation, and near-95% progression-free survival at twelve months. The clinical consensus is not emerging. It has emerged. What remains is paperwork.

Journalist Mindy Kitei (@CFSCentral) made the point with admirable precision: the January 6 deadline is a ceiling, not a floor. The FDA has the discretion to act before it. It has exercised that discretion before when the evidentiary case was overwhelming. I would submit — as a patient, as an advocate, and as an attorney who has spent a career reading evidentiary records — that the evidentiary case here is as overwhelming as it gets. The agency's own witnesses said so, on the record, the day before it accepted the application.

I owe a debt of gratitude to Dr. Patrick Soon-Shiong (@DrPatrick) and to ImmunityBio for this drug and for the relentless persistence required to drag it through a regulatory apparatus that does not make persistence easy. ImmunityBio received a Refusal to File letter in May 2025. A lesser company — or a more rationally self-interested one — might have walked away, run a five-year randomized trial the FDA seemed to want, and let the patients absorb the delay. ImmunityBio did not walk away. It submitted additional data. It engaged the agency. It showed up at the workshop. Dr. Soon-Shiong, who attended the May 18 session, has been vocal, public, and unrelenting in pressing the case that bladder cancer patients deserve access to this drug now, not on a bureaucratic timetable calibrated to a distinction his science has rendered meaningless. These are not rent-seekers. These are the people who took the risk — scientific, financial, and reputational — that the system is supposed to reward and mostly doesn't.

I wrote in March about the intermediaries who profit from the complexity of this system— the insurers who have industrialized denial, the hospital billing architectures that relocate patients between floors to satisfy a ledger, the regulatory apparatus that cannot always distinguish between protecting patients and protecting the administrative status quo. I called them rent-seekers, and I used that term with its full Ricardian weight. I do not need to reprise the argument here. The May 18 workshop made it for me. When the FDA's own panelists confirm that 94% of urologists cannot make the diagnostic distinction on which the entire reimbursement architecture rests, the toll booth is visible to everyone.

Let me be plain about what those two months of insurance warfare felt like, because the policy language can sanitize it. It was despair. Not the poetic kind. The clinical kind — the kind where you lie awake calculating whether your bladder will be removed because a claims adjuster in a cubicle has overruled a board-certified urologist on the question of medical necessity. I am an attorney. I have twenty-two years of litigation instincts and a dispositional inability to accept no for an answer. I won. But "winning" should not require a law degree, a combative temperament, a patient girlfriend, and enough disposable rage to treat an insurance appeals process as a second practice. Most patients do not have those resources. Most patients comply with the denial letter. I think about them constantly.

The FDA convened the witnesses. The witnesses testified. The clinical evidence is published. The expert consensus is recorded. The application is accepted. 80,000 patients a year are waiting.

The evidence is in. Act.

David L. McKenzie is an attorney in Raleigh, North Carolina, specializing in intellectual property and First Amendment law. He is a bladder cancer patient advocate.

@BladderCancerUS @mckenzielaw @ChrisCuomo @katiecouric @RandPaul @OncoDailyGU