{"podcast":{"title":"RealTalk MS","slug":"realtalk-ms-779631","podcast_index_feed_id":779631,"rss_url":"https://realtalkms.libsyn.com/rss","website_url":"http://www.realtalkms.com","image_url":"https://static.libsyn.com/p/assets/c/f/6/f/cf6fc1e12c2339c0/Apple_artwork.jpg","author":"Jon Strum","episode_count":517,"summary":"Jon Strum cuts through all the jargon and breaks down the latest multiple sclerosis news. You'll meet the scientists who are creating tomorrow's MS treatments today. You'll hear from the experts discussing how the latest tweaks and changes to our healthcare laws will impact your MS treatment. And we'll be talking to the courageous MS warriors who are out there advocating on behalf of the MS community every day, as well as the men and women who are committed to living their best lives with MS and living their best lives as MS caregivers. If you're dealing with multiple sclerosis in your life -- as a patient, caregiver, family member, or friend -- join us each week for RealTalk MS.","last_synced_at":"2026-07-14T10:18:55.825945+00:00","page_url":"https://stenobird.com/podcast/realtalk-ms-779631"},"episode":{"title":"Episode 440: An MS Specialist's Response to the FDA with Dr. William Conte","slug":"episode-440-an-ms-specialist-s-response-to-the-fda-with-dr-william-conte","published_at":"2026-02-02T23:00:00+00:00","page_url":"https://stenobird.com/podcast/realtalk-ms-779631/episode-440-an-ms-specialist-s-response-to-the-fda-with-dr-william-conte","show_page_url":"https://stenobird.com/podcast/realtalk-ms-779631","url":"https://realtalkms.com/440","audio_url":"https://traffic.libsyn.com/secure/realtalkms/Episode_440_An_MS_Specialists_Response_to_the_FDA_with_Dr._William_Conte.mp3?dest-id=570470","summary":"This past December, the FDA issued a Complete Response Letter to drug manufacturer Sanofi in response to Sanofi's application seeking approval for Tolebrutinib, the first in a new category of investigational disease-modifying therapies to undergo FDA review. A Complete Response Letter is an official letter from the FDA to a drug manufacturer stating that the agency can't approve a new medicine in its current form. It' s not an outright \"no\" that kills a project; it's more like a \"not yet.\" However, this Complete Response Letter raised some issues which, at first glance, don't appear to be easily fixable. Sanofi has pointed out that the issues raised in the Complete Response Letter were markedly different from the guidance they received from the FDA over the course of this approval process. Sanofi has also indicated that it would work with the FDA to find a path forward for Tolebrutinib. Dr. William Conte, an MS Specialist and a principal investigator in the Phase 3 clinical trial for Tolebrutinib, has published an article responding to the FDA's Complete Response Letter. This week, Dr. Conte joins me to discuss the FDA's action and his response to that action. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: We're at the 2026 ACTRIMS Forum :22 Check out the official ACTRIMS Forum Insider podcast! :42 The FDA's Complete Response Letter about Tolebrutinib 1:09 Dr. William Conte responds to the FDA's Complete Response Letter 4:09 Share this episode 38:10 Next week's episode 38:30 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/440 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversatio…","meta_description":"This past December, the FDA issued a Complete Response Letter to drug manufacturer Sanofi in response to Sanofi's application seeking approval for Tolebru…","key_points":[],"chapters":[],"topics":[],"duration_seconds":2359,"processing_state":"not_requested","actions":[{"name":"request_transcript","method":"POST","url":"https://stenobird.com/v1/public/podcasts/realtalk-ms-779631/episodes/episode-440-an-ms-specialist-s-response-to-the-fda-with-dr-william-conte/transcription-requests","description":"Idempotently request low-priority transcript generation for this episode."},{"name":"read_markdown","method":"GET","url":"https://stenobird.com/podcast/realtalk-ms-779631/episode-440-an-ms-specialist-s-response-to-the-fda-with-dr-william-conte.md","description":"Read the agent-friendly Markdown representation of this episode resource."}]}}