Episode 440: An MS Specialist's Response to the FDA with Dr. William Conte
RealTalk MS2 Helmi

Episode 440: An MS Specialist's Response to the FDA with Dr. William Conte

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 conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: jon@realtalkms.com
Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

Support Jon at WALK MS
https://realtalkms.com/walkms

Find out about ABLEnow Accounts
https://ablenow.com

JOIN: The RealTalk MS Facebook Group
https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review
http://www.realtalkms.com/review

Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com.

RealTalk MS Episode 440
Guests: Dr. William Conte

Privacy Policy

Jaksot(503)

Episode 212: Mobility Rehabilitation Early and Late in Your MS Journey with Dr. Herb Karpatkin and Cinda Hugos

Episode 212: Mobility Rehabilitation Early and Late in Your MS Journey with Dr. Herb Karpatkin and Cinda Hugos

Early in your MS journey, it's not uncommon to experience minor walking and gait issues. And people living with advanced MS often face more serious mobility challenges. The good news is that rehabilit...

20 Syys 202144min

Episode 211: The Ins and Outs of Employment and MS with Dr. Phillip Rumrill

Episode 211: The Ins and Outs of Employment and MS with Dr. Phillip Rumrill

Having a job matters. Most obviously, employment provides the economic resources that people need to more easily manage every other aspect of their lives. Perhaps less obviously, we tend to define our...

13 Syys 202140min

Episode 210: Getting that Cognitive Assessment with Cathy Chester

Episode 210: Getting that Cognitive Assessment with Cathy Chester

Cognitive issues affect a majority of people living with MS and experts often recommend a cognitive assessment as the first step in managing cognitive dysfunction. But what's that cognitive assessment...

6 Syys 202133min

Episode 209: MS Superheroes with Madison Copot

Episode 209: MS Superheroes with Madison Copot

Madison Copot was diagnosed with MS about 9 years ago, just before turning 13. And when she received her diagnosis, Madison was also told that she was too young to be seen by an MS specialist. Today, ...

30 Elo 202128min

Episode 208: COVID-19 Vaccine Update: The Third Dose and MS with Dr. Nancy Sicotte and Victoria Holmes

Episode 208: COVID-19 Vaccine Update: The Third Dose and MS with Dr. Nancy Sicotte and Victoria Holmes

The FDA has authorized a third dose of the COVID-19 mRNA vaccines. What does this mean for people living with MS? Are you eligible for a third dose now? Are you eligible in September? How will your di...

23 Elo 202140min

Episode 207: The Benefits of Art and Music Therapy in MS with Dr. Meera Rastogi, Veronica DeNoma, and Betsy Hartman

Episode 207: The Benefits of Art and Music Therapy in MS with Dr. Meera Rastogi, Veronica DeNoma, and Betsy Hartman

Imagine being able to see improvement in cognition, motor function, and self-esteem, while enhancing neurological functions like walking and speech without taking another pill or even breaking a sweat...

16 Elo 202135min

Episode 206: The Importance of Advocacy with MS Activist Jenna Green

Episode 206: The Importance of Advocacy with MS Activist Jenna Green

If you've ever wondered about whether MS advocacy makes a real difference, please consider that last year alone, MS Activists helped to bring about these changes: $10 Million increase in funding for ...

13 Elo 202133min

Episode 205: A Potentially Transformational Therapy for Progressive MS with Samantha Singer and Dr. Richard Ransohoff

Episode 205: A Potentially Transformational Therapy for Progressive MS with Samantha Singer and Dr. Richard Ransohoff

Just a few weeks ago, life sciences company Abata Therapeutics came out of stealth mode, unveiling a $95 million dollar investment in a novel cell therapy to treat progressive MS. Joining me to talk a...

2 Elo 202132min

Suosittua kategoriassa Terveys ja hyvinvointi

unicast
tiedenaiset-podcast
psykopodiaa-podcast
voi-hyvin-meditaatiot-2
rss-pitaisko-erota
meditaatiot-suomeksi
vakeva-elama-viisaampi-mieli-vahvempi-keho
junnut-pelissa
rss-mighty-finland-podcast
puhu-muru
rss-narsisti
rss-kuumilla-aalloilla
rss-uplevel-by-sonja-hannus
rss-pt-paahtio
rss-vapaudu-voimaasi
mielen-puolikkaat
terapiassa
rss-nautinto
aamukahvilla
rss-en-saa-unta