Mathias Bigger

Scientist turned investor at Bigger Capital

[Michael Bigger @biggercapital]

Whatever Koka Racha says KEBILIDI delivered this! Time to bring AMT-130 to HD patients https://t.co/YkdKghFoUp $PTCT $CLPT $QURE

[Mathias Bigger @BiggerMathias]

$CLPT always advancing. Just like $AMZN.
4 years of work wow, congratulations to Clearpoint and the Somocarelab.

[ClearPointNeuro @ClearPointNeuro]

#ClearPoint Neuro Enters into 10-year Focused Ultrasound Development Partnership with Sungkyunkwan University, South Korea, Further Expanding Our Drug Delivery Ecosystem and Global Footprint - Read More Here: https://t.co/ubbC5bFV6m
#CLPT

[Mathias Bigger @BiggerMathias]

I agree that this is the smartest approach for evaluating the impact of a drug on the American people.
It’s important that along with stakeholders, the patients, their families and the advocacy groups that support them can make informed commentary in the open.
Their perspective acts as data points to determine the state of a treatment deprived community and the risk and urgency required in a situation.
$QURE and the Huntington’s disease community stood strong, signed a petition 40k times and used X to openly challenge the decision the fda made. This dialogue is extremely valuable.

[Houman David Hemmati, MD, PhD @houmanhemmati]

FDA must have the trust of the American people.

Trust must be earned through transparency.

The best form of transparency is to have everything out in the open and permit all stakeholders to view AND participate.

Decisions cannot be made in a black box.

This benefits review divisions by giving them “cover” for unpopular but scientifically/ethically sound decisions.

It benefits patients by letting them see the data and trust the process.

Yes there’s a cost. But it’s a no brainer to have AdComs.

[Rich Law @drrichjlaw]

Feels like the FDA is slowly healing itself.

[Mathias Bigger @BiggerMathias]

The FDA commissioner needs to be someone who understands that clinical biology is an approximate science, and when it comes to rare diseases any sign of efficacy needs to be nurtured and explored not thwarted and roadblocked. Based off of Houman’s tweets I think he’s an excellent candidate!

[Houman David Hemmati, MD, PhD @houmanhemmati]

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.

[Mathias Bigger @BiggerMathias]

Totally agree Desert. Makary goes on media discussing his incredible progress at the FDA using accelerated pathways, data, and AI, then turns around and recommends a sham control when the comparative data already exists. For heavens sake the fda aligned on it in April 2025, Makary reneged. He does not have the interest of the patients in mind.

[Mathias Bigger @BiggerMathias]

1. Put time pressure on $BEAT regulatory agent who then rejected their 12 lead ecg algorithm, they appealed and two weeks later it got approved

2. Claims that $QURE AMT 130 data is not enough to support approval, proceeds to go on cnbc and announce npmi and bash AMT130 saying it does not work. If the data wasn’t powered to meet his standards how can he then say the drug is ineffective? This slowed down AMT130 path to patients - costing them valuable time.

3. Other cases of pressuring his scientists to issue CRL and is forced to then review those very CRL due to outcry.

4. Introduced so much risk to biotech investing because the word of the FDA lost integrity. The companies who need cash to fund a trial based on the confidence of the fda alignment are struggling to raise money to fund trials.

[Mathias Bigger @BiggerMathias]

Did not have the lives of patients in mind, show him the door. Prasad and Makary will be giving tutoring lessons next fall. $QURE $CLPT

https://t.co/4qLUXPPZOO

[Mathias Bigger @BiggerMathias]

@idalopirdine @houmanhemmati

[Dr. Toonces, MD, PhD @DrToonces]

President Trump just demonstrated something important.

When he wants the FDA to act, the FDA acts. Per WSJ this week, he pressured Makary directly on flavored vapes and the agency reversed.

Huntington's families have been waiting six months for that same intervention. AMT-130 works. The data is overwhelming. One conversation could change everything.

$QURE #AMT130
https://t.co/nELSHJgxlM

[Rick Santorum @RickSantorum]

I supported his nomination because he spoke truth during COVID. He immediately fired the best leaders at the FDA, replaced them with anti-Trump leftists who hollowed out FDA, harmed patients, stifled innovation & drove bio-tech to China then lied about it. https://t.co/3ZrqCVuuPm

[Dr. Toonces, MD, PhD @DrToonces]

This is the smoking gun. A career FDA reviewer resigned over political pressure to block a rare disease drug, named Prasad directly, and said the review document supported approval.

The HD community has been screaming this for 6 months. Now it’s on the Congressional record.

#AMT130 $QURE

[ClearPointNeuro @ClearPointNeuro]

#ClearPoint Neuro Announces FDA Clearance of the Velocity Alpha(R) MR High Speed Surgical Drill System and First Clinical Use, Further Expanding Our Drug Delivery Ecosystem and Global Footprint

Read More Here: https://t.co/Cg0Wd6fQJW

#CLPT

[AuxReignots @Reignots]

Holy bullish for $CLPT - partners are undervalued, they are undervalued^2

[Rob Mani @ManRam930]

Massive win for $CLPT! UCB just acquired Neurona Therapeutics for up to $1.15B to accelerate regenerative cell therapy for drug-resistant epilepsy. Every dose of NRTX-1001 is delivered via $CLPT. This is the kind of validation that moves the needle hard. Full speed ahead 🚀

[stepfanie tyler @stepfanie]

If you hate billionaires, go all the way, pussy.

Ditch the iPhone, the laptop, the tablet.
Get off the internet.
No Amazon, no big box stores, no Starbucks.
Grow your own food. Thrift your clothes. Walk everywhere.

And obviously no working for, buying from, or interacting with any company that scales beyond a farmers market.

Enjoy your abundance.

[Mathias Bigger @BiggerMathias]

@SnackBioTech @biggercapital Someone needs to change his diaper

[Mathias Bigger @BiggerMathias]

@SnackBioTech @biggercapital Here’s the little guy again. Pocket watching others with no accomplishments to show for himself.