Mathias Bigger @BiggerMathias
Scientist turned investor at Bigger Capital biggercapital.com Las Vegas Joined October 2013-
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This quote right here published today is the very definition of functional stability in a progressively deteriorating disease. That’s unequivocal AA territory. Might make a new diss track w/Drake and call it “back-to-back-to-back”. $QURE
Whatever Koka Racha says KEBILIDI delivered this! Time to bring AMT-130 to HD patients youtube.com/shorts/6vqkWPD… $PTCT $CLPT $QURE
New link that wasn't on the FDA site yesterday: fda.gov/science-resear…
$CLPT always advancing. Just like $AMZN. 4 years of work wow, congratulations to Clearpoint and the Somocarelab.
#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: ir.clearpointneuro.com/news-events/pr… #CLPT
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.
@RxRegA 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
Feels like the FDA is slowly healing itself.
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!
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
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.
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.
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 wsj.com/health/healthc…
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 wsj.com/politics/polic…
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. wsj.com/opinion/presid…
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
Look at the full quotes from these career FDA scientists. Could it be any more clear that Prasad unilaterally torpedoed $QURE AMT-130? auchincloss.house.gov/media/press-re…
#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: ir.clearpointneuro.com/news-events/pr… #CLPT
Holy bullish for $CLPT - partners are undervalued, they are undervalued^2
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 🚀
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.
@SnackBioTech @biggercapital Someone needs to change his diaper
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