J sooks🇹🇹

I really did not want to be writing this morning. But this issue is too important. It’s been said that the last thing the weather person should do before going on the air is look out the window. The _day before_ @eringriffith profiled Medvi in @nytimes as the AI company of the future, the FDA approved Lilly’s new oral medication: orforglipron. *Not tirzepatide.* In fact, it’s not even a peptide. It’s the first non-peptide, small-molecule oral GLP-1 receptor agonist. Lilly owns tirzepatide. They invented it. If you could put tirzepatide in a pill, Lilly would do it. They would desperately want to. Instead, they spent millions and nearly eight years licensing a completely different kind of molecule, because oral tirzepatide is a biological impossibility. Tirzepatide is a 39-amino-acid, 4,813-dalton peptide. Your gut does not distinguish it from a piece of chicken. SNAC, the absorption enhancer that barely gets oral semaglutide to 1% bioavailability, is compound-specific. It failed with liraglutide, another GLP-1 peptide, and has no demonstrated mechanism for tirzepatide. There is no published human study of oral tirzepatide. There is no plausible mechanism. Medvi sells it starting at $279 a month. A RICO class action against its supply chain partners has already called the product modern-day snake oil. Lilly’s own strategy is the best witness. We can hear the lawyers now: “So doctor, what was your assumption on why Lilly was not pursuing oral tirzepatide despite that in not doing so they would instead pursue an entire entirely different type of molecule and possibly create market confusion with their new entrant?” The Times profile actually described an accountability architecture whose impact in part is that no single entity owns the patient and process. Medvi handles marketing. CareValidate provides the clinical workflow. OpenLoop provides prescribers and pharmacy fulfillment. The marketing layer can say the doctors make the decisions. The doctor platform can say the brand controls the messaging. The prescribers say the pharmacy fills what’s ordered. Everyone can point at everyone else. That structure explains a lot of the financials. Medvi reported a 16.2% net margin. Hims, with 2,442 employees selling the same drug categories, reported 5.5%. The 10.7-point spread represents in part everything Medvi may not pay for: extensive clinical oversight, advanced adverse event monitoring, satisfactory regulatory compliance, sound quality systems. The Times says they verified Medvi’s revenue. They did not seem to verify or note many other aspects. Six weeks before the profile ran, the FDA had issued Warning Letter #721455 for misbranding compounded GLP-1s. OpenLoop had disclosed a data breach: a threat actor claimed access to 1.6 million patient records, and multiple class actions were filed. The company’s ad network included fabricated physician personas, “Professor Albust Dongledore,” “Dr. Tuckr Carlzyn MD,” running over 5,000 Meta ads alongside a website disclaimer that these individuals “may be actors or AI portraying doctors.” The Times told the story of a man who used AI to build a billion-dollar company alone. The article was really a transcript of a Silicon Valley fever dream. A byproduct of regulatory lag and consumer desperation A billion dollars in pharmaceutical transactions running through an organization with no one seeming to care if a product can survive contact with the human stomach better than a chicken nugget.

x.com/i/article/2040…

The Government is set to overhaul Trinidad and Tobago’s construction permitting system, with Cabinet approving the removal of a long-standing public health approval requirement in a bid to cut delays and stimulate development. For more: guardian.co.tt/news/govt-to-r…