{"podcast":{"title":"The Doctor's Lounge","slug":"the-doctor-s-lounge-7442524","podcast_index_feed_id":7442524,"rss_url":"https://api.riverside.fm/hosting/5aWyTD7j.rss","website_url":"https://thedoctorslounge.buzzsprout.com","image_url":"https://hosting-media.riverside.com/media/podcasts/59501f59-aca4-4def-bd99-a043a6802263/logos/147cc477-82c6-40d3-8a78-59fd96e7eb31.png","author":"The Doctor's Lounge","episode_count":64,"summary":"Where scalpels meet systems — and physicians say what they really think. Co-hosted by Anish Koka, MD & Anthony DiGiorgio, DO. Candid talks on healthcare policy, reform, physician autonomy & patient care.","last_synced_at":"2026-06-21T14:17:24.601594+00:00","page_url":"https://stenobird.com/podcast/the-doctor-s-lounge-7442524"},"episode":{"title":"The FDA, Unicure, and the Limits of Accelerated Approval","slug":"the-fda-unicure-and-the-limits-of-accelerated-approval","published_at":"2026-05-25T12:00:00+00:00","page_url":"https://stenobird.com/podcast/the-doctor-s-lounge-7442524/the-fda-unicure-and-the-limits-of-accelerated-approval","show_page_url":"https://stenobird.com/podcast/the-doctor-s-lounge-7442524","url":"https://api.riverside.com/hosting-analytics/media/0a0221050f5f11140efcac22b18ea955bf07d00346c2184c46a458d6e8b45317/eyJlcGlzb2RlSWQiOiI3OWQzMGI1MC1jZmE2LTQ1NWUtYWY2Yy00NGRhOGJmMWJlY2IiLCJwb2RjYXN0SWQiOiI1OTUwMWY1OS1hY2E0LTRkZWYtYmQ5OS1hMDQzYTY4MDIyNjMiLCJhY2NvdW50SWQiOiI2OTJmNTE0YTZlYjA1ZDMyNzdmZTA2OWQiLCJwYXRoIjoibWVkaWEvY2xpcHMvNjlmNGVhNzlhMzBmZDVmYTUxMDIxMjk3L2RvY3RvcnMtbG91bmdlcy1zdHVkaW8tY29tcG9zZXItMjAyNi01LTFfXzIwLTEtMjkubXAzIn0=.mp3","audio_url":"https://api.riverside.com/hosting-analytics/media/0a0221050f5f11140efcac22b18ea955bf07d00346c2184c46a458d6e8b45317/eyJlcGlzb2RlSWQiOiI3OWQzMGI1MC1jZmE2LTQ1NWUtYWY2Yy00NGRhOGJmMWJlY2IiLCJwb2RjYXN0SWQiOiI1OTUwMWY1OS1hY2E0LTRkZWYtYmQ5OS1hMDQzYTY4MDIyNjMiLCJhY2NvdW50SWQiOiI2OTJmNTE0YTZlYjA1ZDMyNzdmZTA2OWQiLCJwYXRoIjoibWVkaWEvY2xpcHMvNjlmNGVhNzlhMzBmZDVmYTUxMDIxMjk3L2RvY3RvcnMtbG91bmdlcy1zdHVkaW8tY29tcG9zZXItMjAyNi01LTFfXzIwLTEtMjkubXAzIn0=.mp3","summary":"Episode Summary Anish sits down with Adu, a med student and biotech investor, to work through the FDA's contested handling of Unicure's AMT-130 — a gene therapy for Huntington's disease delivered via stereotactic brain injection. They debate whether the underlying data justifies approval, why the agency's mid-course reversal has rattled the investor community, and what the Sarepta precedent should have taught everyone involved. The conversation broadens into a bigger question: given that desperate patient populations will always demand access to anything showing a signal, who is actually best positioned to make the call on whether a drug works — the FDA, the clinician, or the market? Chapter Markers 00:00 FDA approval of AMT-130 and investor reaction 01:16 Unmet need and the case for regulatory flexibility 02:37 Sarepta, Duchenne's, and the cost of approving under pressure 05:09 Accelerated approval done right: the Amylyx example 09:14 Debating the AMT-130 data and the historical control problem 13:53 Why stock price matters for trial funding 17:20 How Prasad could have changed FDA culture differently 19:37 The FDA's role from Kefauver-Harris to today 22:26 Competing Huntington's therapies in the pipeline 25:39 Prasad's tenure: what worked, what didn't 28:27 Media coverage of the FDA and science journalism Co-Host Handles @anish_koka and @drdigiorgio Show Handle @drsloungepod","meta_description":"Episode Summary Anish sits down with Adu, a med student and biotech investor, to work through the FDA's contested handling of Unicure's AMT-130 — a gene t…","key_points":[],"chapters":[],"topics":[],"duration_seconds":3189,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/the-doctor-s-lounge-7442524/episodes/the-fda-unicure-and-the-limits-of-accelerated-approval/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/the-doctor-s-lounge-7442524/the-fda-unicure-and-the-limits-of-accelerated-approval.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}