Compound Tirzepatide: Time to Stock Up? скачать в хорошем качестве

Compound Tirzepatide: Time to Stock Up?

WAYS TO SUPPORT MY WORK ⬇️ http://www.otplinks.com 00:00:01 – 00:00:23 Episode agenda preview • Stocking up on compounded injectable GLP 1 meds • Zepbound QuickPens via LillyDirect • Whether the 45 day requirement goes away • Reddit reports of people trying retatrutide 00:00:46 – 00:01:27 Show intro and mission • What the show covers, goal is helping people have better doctor conversations • Calls to like, subscribe, rate the podcast 00:01:27 – 00:08:13 Eli Lilly earnings call takeaways • Retatrutide timeline and submission plan for obesity, osteoarthritis, obstructive sleep apnea, aiming for availability beginning to mid 2027 • Retatrutide positioned as escalation therapy, not a Zepbound replacement, and likely priced accordingly • Brinipetide as a next gen GLP GIP, with trials planned in neurological and psychiatric areas (alcohol use disorder, tobacco, bipolar disorder, major depressive disorder) • Phase 3 trial starting for tirzepatide in type 1 diabetes • Zepbound QuickPens status, described as launching in coming days, with expectation the 45 day refill requirement drops around spring or aligned with launch 00:08:28 – 00:12:17 Why people are asking about stocking up, the trigger events • Novo Nordisk earnings call context and Wegovy pill launch performance, 170k prescriptions, mostly starter dose, mostly new therapy patients • Hims and Hers launches a compounded pill priced at $50 and markets it as the same active ingredient as Wegovy pill • Explanation of why oral semaglutide is hard, Novo’s absorption technology, low absorption rate, and why “same active ingredient” messaging can mislead on oral bioavailability • Escalation of reaction from FDA leadership and lawmakers, leading to an FDA letter released Friday 00:12:52 – 00:15:08 FDA letter and what it claims • FDA intent to take decisive steps to restrict GLP 1 APIs used in non FDA approved compounded drugs that are being mass marketed • FDA says companies cannot claim compounded products are generic, the same as, or use the same active ingredient as FDA approved drugs • Framing this as a direct response to Hims and Hers advertising 00:15:08 – 00:23:13 Alliance for Pharmacy Compounding response and what it means for patients • APC letter to FDA pushes back, argues about prescriber judgment and patient specific care • APC argues API sourcing framework implies it is the same active ingredient, while also agreeing compounds are not FDA approved and should not be marketed as such • Discussion of the FDA green list and alleged inconsistency in FDA posture • Point that enforcement focus appears heavier on regulated compounding versus gray market peptides • Take that more framework could be good because compounds are still expensive and patients deserve sterility and authenticity • APC asks FDA to slow enforcement, which is framed as a reason patients should plan continuity of care with their doctor • Host belief: not an overnight shutdown, but risk of interruption exists 00:21:34 – 00:22:21 Novo also receives an FDA letter • Bloomberg context that Novo got a letter about Wegovy pill commercials suggesting pills are better than injections • Framed as FDA reining in marketing on both sides, not just compounding 00:23:25 – 00:25:19 Super Bowl and culture moment around obesity and GLP 1s • Weight loss ads and obesity narrative during the Super Bowl (Ro, Hims and Hers, Wegovy pill ad) • Mentions a fat shaming style video and stigma concerns • Emphasis that obesity is a chronic relapsing disease and creators should be mindful of bias 00:25:20 – 00:30:48 Novo Nordisk lawsuit against Hims and Hers, why it is different • Lawsuit described as patent infringement, contrasted with the usual trademark or cease and desist pattern • Argument that some compounders want to challenge peptide patents because these mimic endogenous hormones • Explanation of why these drugs are patentable in practice, half life engineering, binding affinity, innovation • Theory that Hims and Hers baited a patent fight through aggressive pill launch messaging and pricing • Concern about balancing access through compounds with preserving pharma innovation incentives 00:30:49 – 00:31:34 Wrap up and next content teaser • Lawsuit could take years or settle • Teases upcoming interview with Dr. Rachel Goldman, an Oprah panelist on the GLP 1 and obesity special • Final calls to subscribe and share