The FDA Commissioner role is open. This is a pivotal moment for American medicine — & for American patients. Here’s what I believe the next Commissioner should stand for. Not as a wish list. As a baseline. 🔬 1. BRING BACK THE ADCOMS — AND MAKE THEM COUNT. Advisory Committee meetings are one of the FDA’s most powerful tools for transparency. They should return in full force. Open. Public. And real. Patients, doctors, scientists, advocates, & skeptics should all be able to speak. But if you want to speak, you fill out a financial conflict-of-interest form under penalty of perjury — & you read it out loud at the podium before you say another word. Every single person. And if the issues are complex and the science requires more than one day, then take the time. Don’t cut people off because the schedule says so. The public deserves to see exactly how these decisions are made. Real transparency builds real trust. ⚖️ 2. STOP ASKING ONLY “IS IT SAFE ENOUGH TO APPROVE?” — START ASKING “WHAT HAPPENS IF WE DON’T?” For rare diseases. For serious conditions with no good options. For patients who don’t have ten years to wait for traditional trials that may never be feasible. Every regulatory decision carries two risks: the risk of approving something, and the risk of not approving it. Both are real. Both affect real people. When traditional gold-standard trials aren’t practical, we should still be able to move with urgency — but only when paired with strong post-approval commitments and rigorous safety monitoring. We can give desperate patients a chance without abandoning scientific integrity. 🇺🇸 3. THE FDA’S ONLY CLIENT IS THE AMERICAN PATIENT. FULL STOP. The FDA exists to serve patients — not outside interests or external pressures of any kind. It must continue protecting the public from products that carry real, known risks but offer no meaningful clinical benefit. At the same time, when there is credible evidence that a treatment can help patients with serious conditions, Americans and their physicians should be trusted to make informed decisions once they have complete and honest information about the risks, benefits, and alternatives. The FDA’s job is to make sure the science is sound and the information is clear. Then let patients and doctors do what’s best for them. These principles matter because the FDA’s decisions affect every family in this country. Note: This is a simple social media post and not a massive policy document. The issues are FAR more nuanced, there are challenges and risks with each of the things I said above, and I recognize that. But it's intended to serve as a discussion starter. We must always strive to improve, and we can when we have open debate and dialogue.

Please take a moment to read this article. I am proud to call Peter a friend. He went beyond an investment and learned what people go through in real life. That matters a lot more than just making money in a stock.

$clpt Neurona getting bought out = game changing moment, the 2 epilepsy programs are golden, and Alzheimer’s third program is going to get money thrown at it. Market is sleeping on what this truly means. One of the most important days in clearpoint history.

$QURE presented at NORD on April 14. There was a nugget in that presentation that I found very interesting and what it means for the incoming CBER director. Free article below. botn.bio/p/an-important-nugg…

$clpt Neurona Interesting early abstract, more data on the 22nd The first bilateral MTLE subject treated with NRTX-1001 achieved seizure freedom and continues to be seizure-free at 6 months (time of abstract submission). These data, and data for additional subjects treated, will be presented at the conference. @peter_mantas @biggercapital @NeuroStockDoc index.mirasmart.com/AAN2026/…

$qure Listen to Sarah Tabrizi explaining AMT-130 and how two patients went back to work. Please share and retweet. This was last week at the Samuel Gee lecture.

🤔From the FDA's public calendar: On Mar 3, 2026, FDA Commissioner Makary met with "Arnold Ventures representatives" at FDA headquarters in Silver Spring, MD. Multiple FDA staff attended. [1] | Subject: "Collaboration Opportunities" Here's what was happening that same week: — $XBI $QURE #FDA

This is how an @HHSGov / @US_FDA official speaks in public. Imagine the conversations and behaviors internally. Meanwhile, as they stonewall a promising therapy in AMT-130, Christina's father continues down the painful path of Huntington's disease. I suppose Christina's family must deserve it – because they're part of the "swamp." The "swamp" Nixon is referring to includes the ~48,000 individuals from the Huntington's community behind the two petitions delivered to the FDA. Petitions the FDA did not even review. @SenGillibrand | @lukaske @SenRickScott | @ClareLattanze @SenRonJohnson | @GraceCarnathan @RepAuchincloss | @GeorginaBurros It doesn't have to be this way. You have thousands of bipartisan constituents watching proudly of the actions you've taken so far. The latest being the press conference on Mar 10th that @SenRonJohnson held. For the sake of Christina and the millions of rare disease patients, keep going.

JUST RELEASED: Episode 17 - Market Stoplight Session of Shooting The Bull Pod with Drowsy and @investing_bear This week’s: Green Light - Reddit $RDDT Yellow Light - Nebius $NBIS Red Light - SpaceX IPO & $ASTS open.spotify.com/episode/3B3…

New from me on $QURE and FDA. Free, no paywall. The FDA, urged to avoid controversy, creates a new headache with attack against UniQure Anonymous diatribe from a senior official plunges agency back into headlines statnews.com/2026/03/06/fda-…

My letter to the @SenateAging, @SenRickScott, @SenGillibrand on the FDA's recent FDA's handling of AMT-130 for Huntington's disease. The same day the FDA called it a 'failed product', the UK Government officially called it a breakthrough. The HD community deserves better.

$qure another point that many get wrong: The Co is/was prepared to conduct a larger study; it did not expect to see promising data so early... ...in fact the FDA spotted it with them and awarded RMAT. uniQure then followed the agency's advice only to have the goal post shifted afterwards. That is the issue, not the details around what would be an ethical control group, or that the Co does not believe per se that a confirmatory study is (financially) feasible.

Pre-ordered today

Gave a proper hat tip to @Iqbal_yusuf1994 @LockStockBarrl @majgeoinvesting @mrjones321 @NeuroStockDoc and others for $AUUA.V $DBO.TO $TSSI $KLNG $BLM.V $SNWV $ACNT $ZDC.V

$clpt hello catalyst fda.gov/news-events/press-an… foxbusiness.com/media/fda-ro…

$TWST is -43% YTD, -73% over 5 yrs. But I often hear $TWST being mentioned (unprompted) as the BEST in what they are doing - long DNA synthesis. W/ ~$400m annual rev growing @ ~20%, $TWST would go for 10-12x rev in a bake-off. $DHR & $TMO would fight to death 4 this platform

A new treatment paradigm for drug resistant epilepsy. Injection instead of surgery. Total rule breaker Made possible by $CLPT

This is a good deal for the space and for related picks and shovels (eventually) $RNA $TWST $MRVI etc

$CLPT is the leader in precision targeting for gene therapy delivery for the central nervous system