Right-to-Try 2.0: Inside the Montana Model with Niklas Anzinger — The Doctors’ Lounge

Episode Summary

Anish 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 Markers

00:22 Introducing Niklas Anzinger and his path from economics and VC to biotech policy

03:05 Montana SB535 explained — right-to-try, but with a for-profit pathway

06:01 Phase 1 vs phase 2 vs phase 3, and why bypass the later stages

11:37 Does SB535 cover devices as well as drugs

14:15 The semaglutide timeline as a case study in regulatory delay

18:36 Federal right-to-try, the baby KJ case, and why it isn't enough

23:25 The payment problem — how a non-FDA-approved treatment actually gets paid for

33:11 What "smart regulation" would look like with carte blanche over the FDA

48:31 Why Montana's biggest need right now is clinicians, not biotechs

49:57 The practical burden on a private practice running these treatments

53:32 Observational data vs. randomized trials — the risk of junk data