Right-to-Try 2.0: Inside the Montana Model with Niklas Anzinger

Send us Fan MailEpisode SummaryAnish Koka and Anthony DiGiorgio sit down with Niklas Anzinger, a venture capitalist and founder of Infinita VC, to unpack Montana SB535 — a new law that lets doctors administer treatments to patients that have only cleared FDA phase one trials, through licensed "experimental treatment centers" overseen by independent review boards. The conversation covers why Eroom's Law has made drug development slower and more expensive despite scientific advances, how the Montana model differs from existing right-to-try and expanded access programs, the thorny question of who pays when a treatment sits outside FDA approval and insurance coverage, the risks of messy observational data replacing randomized controlled trials, and how Anzinger's work connects to special economic zones like Prospera in Honduras, where he's speaking to the hosts from.Chapter Markers00:22 Introducing Niklas Anzinger and his path from economics and VC to biotech policy03:05 Montana SB535 explained — right-to-try, but with a for-profit pathway06:01 Phase 1 vs phase 2 vs phase 3, and why bypass the later stages11:37 Does SB535 cover devices as well as drugs14:15 The semaglutide timeline as a case study in regulatory delay18:36 Federal right-to-try, the baby KJ case, and why it isn't enough23:25 The payment problem — how a non-FDA-approved treatment actually gets paid for33:11 What "smart regulation" would look like with carte blanche over the FDA48:31 Why Montana's biggest need right now is clinicians, not biotechs49:57 The practical burden on a private practice running these treatments53:32 Observational data vs. randomized trials — the risk of junk data59:15 Is this a domestic answer to China's faster phase one pathway1:04:22 Roatan, Prospera, and the case for special economic zones in medicine1:09:18 Closing thoughts and where to find Anzinger's Stranded Technologies podcastCo-Host Handles@anish_koka and @DrDiGiorgioShow Handle@DRsLoungePodSubscribe LinksSpotify: https://open.spotify.com/show/44vw8eirsKKnjgNIrdDvrRApple Podcasts: https://podcasts.apple.com/us/podcast/the-doctors-lounge/id1832097658YouTube: https://www.youtube.com/@TheDoctorsLoungePodMr. Niklas Anzinger on X: @NiklasAnzingerMr. Niklas Anzinger Podcast:Stranded Technologies podcast🔗 Connect with the Hosts:• Dutch Rojas on X• Dr. Anthony DiGiorgio on X• Dr. Anish Koka on X• Dr. Dan Choi on X• Dr. Sanat Dixit on X