Piri Reis

@emilyakopp @maxonwifi He messed up the whole organization. What are you smoking

FDA under Trump began with people known for courage during COVID: Marty Makary, Vinay Prasad, Tracy Beth Hoeg. All gone. To be replaced with status quo picks. Now @maxonwifi reports pharma pressured the White House. They "really were out to get" Makary.

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW It was probably out of convenience and practicality but I don’t think they have any issues raising cash from investors.

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW I think they tapped the atm once and that was to pay for epilepsy

What's a resonable valuation for Biohaven on the Kv7-program alone? $BHVN

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW But mathematically it is not possible. You cannot get below 50% the median reduction if 56% of patients have at least 50 percent reduction in ole.

@develiforever @BioN00b @AaronRosenblum5 @nociFTW Hard to explain it to you on X. Plug the PK graph into AI ask given the fat right tail how can an MCP of 42% achieve 55% RR50. The fat right tail suggests there is a group of high responder that pulls up the RR50 yet the medium MCP can still be low.

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW I think it is the low cash position. A good trial result would mitigate this greatly. The short interest is way too high

@develiforever @BioN00b @AaronRosenblum5 @nociFTW The stock loses a trust premiums when Bhvn try to gain a short sighted financial window for raising money though overpromising and spinning the drug potential.

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW I am not sure about this inference. If the rr50 is 56%, how would your mpc is below 50%? At least in ole

@develiforever @BioN00b @AaronRosenblum5 @nociFTW And use historical efficacy regression see in OLE to double blinded placebo trial the range is rough roughly 35-42%. Might compete well with $xene 1101 if sold by Pfizer no chance to beat Xene if selling themselves.

@BiotechCLin @BioN00b @AaronRosenblum5 @nociFTW How did you inter this range? Is it from the plasma concentration chart?

@BioN00b @AaronRosenblum5 @nociFTW The market is expecting Azetukalner result when its MCP will likely be in 32-42 % range in my model. Azetukalner has very little GABAa interaction. Simply look through my previous replies. If you are interested read through my substack analysis section 8.

@anish_koka You are an idiot, there are some rare disease drugs that you cannot run a controlled arm. Especially Prasad did not like any single arm trials. Also thr morale was terrible at the Fda and many left

My take is that Makary and prasad approved a wide array of therapeutics that actually worked that didn’t have an RCT and cowrote a number of articles in a little “paywalled journal” called the NEJM 🙄 outlining a framework for lowering the regulatory bar for promising therapies. Their exit from the FDA has more to do with the lord of the flies ecosystem of incompetent middle managers in charge at the FDA and in Congress that exploit rare disease patients to demand the nurturing of zombie companies with therapies that don’t work/could potentially be dangerous. Makary would have had to overturn an FDA on therapies that were potentially dangerous with incredibly weak signals of efficacy. The first decision that lead to Vinay’s firing was keeping a drug on the market that was killing kids (approved with similar dubious data) But I don’t think it would have mattered in the end. Makary and Prasad were outsiders who thought they had a mandate to disrupt a hierarchy and they elicited a fierce antibody response. What the politicians need when gas is $5/gallon and midterms approach are not headlines about FDA in chaos that are sourced from the status quo partisan zipcode the FDA resides in. That requires someone who FDA middle management approves of which is basically someone more well versed in politics than science. More broadly, we should allow for expanded access to whatever people want to try— whether the FDA approves it or not. At the moment FDA approval translates to billion dollar valuations because it comes with the defacto mandate third parties pay. Third party payment is you .. you pay that in the form of taxes/health insurance premiums. A world where you try whatever you want and funding comes from private foundations if blue cross decides not to cover something makes it a lot harder for @AppleHelix @MartinShkreli et al to get a return on their investment. Ignore the noise , that’s really what this is about

@nytimes @johnarnold good bye to your wicked policies

Breaking News: Dr. Marty Makary resigned as commissioner of the FDA, according to an administration official, after weeks of pressure and rumors that President Trump was planning to fire him. nyti.ms/3Pjpfjp

@BiotechCLin There are 25 million shares shorted. A lot of the float is held by long term investors. It is a matter of time in my opinion. One good news could be enough. 35-40% efficacy with this ae profile would be enough to sell the asset to big pharma.

@develiforever Did you never wonder why they only show RR50 and claim similar to xenon ? But not show MCP ole data ? I plan to sell after their investors day. I expect the degrader platform will show fantastic result, but I will move on into AI stocks. Market is pricing for dilution not science

open.substack.com/pub/biotechcli… $BHVN 2026 Q1: Burn still ~$153M/qtr What’s new ? 17.2M shares diluted ATM now $350M The “60% R&D cut” was financed by dilution, not discipline. Science is not the problem. Dilution is.

Thanks Mike. While in US, an ex-Enron oil analyst gets a say in what scientific standard for rare disease accelerated approval should be, over 100 leaders from non-profit/Advocacy groups, the industry, investors. Or ex-CBER head who lied in his CV got to decide, over 22 world famous melanoma oncologists, that terminally-ill cancer patients' survival is not enough for accelerated approval because it's a single arm trial. For patients' sake, we must do better. $QURE $REPL rtwinstitute.org/media/v4zoajqw… & linkedin.com/posts/melanoma…

@DrMakaryFDA Good bye my friend. You created such a turbulence at the agency

Pregnant women shouldn't be left guessing about how approved drugs could affect their pregnancy. Our new FDA guidance is designed to help close that information gap.

@alp_bugdayci Ne sacmalasin

Fakat ama bence şu da var: Sovyetler, 30 Mayıs 1953 tarihli notayla Türkiye üzerindeki toprak taleplerinden tamamen vazgeçmişlerdi. Hatta 1960’larda İsmet İnönü ile görüşen bir Sovyet devlet adamı, bu talepleri açıkça bir hata olarak nitelendirmişti. Ancak bence burada asıl mesele şudur: Türkiye, 1953 sonrasında Abd ile ilişkilerini pragmatik bir caydırıcılık aracı olarak kullanmak yerine, bu ilişkiyi giderek daha bağımlı ve muhtaç bir zeminde tanımlamayı tercih etti. Nitekim bu eleştiriyi 1953 sonrasında dile getiren ve gerektiğinde “gerekirse yeni bir dünya kurulur, Türkiye de orada yerini bulur” diyerek daha bağımsız bir çizgiyi savunan kişi yine İnönü’ydü. Türkiye, özellikle 1950’lerin ikinci yarısından itibaren ulusal çıkarları doğrultusunda daha dengeli ve özerk bir dış politika izleyebilirdi. Ancak bu yönde bir tercih yapılmadı. Zira İnönü dışında, 1970’lere değin Türkiye’deki hükümetlerin büyük ölçüde Abd ile kurulan bu bağımlılık ilişkisinden rahatsızlık duymadıkları görülüyor. Esas sorun da bu’ydu işte.

@WSJ The fda has been a mess under his watch. It has been way too long.

Exclusive: President Trump has signed off on a plan to fire FDA Commissioner Marty Makary after clashes with the regulator over vaping, abortion and drug policy on.wsj.com/42VtNj9

@BiotechCLin Why so low? Their ole data is similar to that of xenon.

@develiforever 75mg MCP will be 33-42 % based on the model I ran, but without CNS AE. Market might react to it negatively since $xene XEN1101 has a MCP ~ 53 percent. Difficult to sell against XENE efficacy narrative by BHVN. Easy blockbuster if sold by Pfizer using the safety narrative.

@BiotechCLin What is your view on the epilepsy program? The potassium channel pathway has already been shown to work. Don’t you think it is derisked into the data readout?

@develiforever If they do what I preach for we are talking about a 40B MC Argenx like opportunity. The degrader platform is highly promising and they rather dilute shareholders to feed the peripheral program.

@business Fire this guy @WhiteHouse

Marty Makary seemed like an ideal fit to lead the Food and Drug Administration. But he’s run into criticism from within the agency, where he has a reputation for paranoia, and outside of it, after presiding over high-profile drug setbacks bloomberg.com/news/newslette…

@Hale_Storm They have a strong case

WSJ seems obsessed with Makary

@DigitalOracle17 @Reuters You can’t do that with all the rare diseases

@Reuters The FDA’s position is consistent: without randomized, controlled evidence, approval isn’t legally viable—no matter how promising early results look.

FDA Commissioner Makary defends agency's decision on Replimune's drug, CNBC reports reut.rs/3OXXuwT reut.rs/3OXXuwT