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

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

Episoder(503)

Episode 189: Research on Sex Differences in MS Leads to Potential Treatment with Dr. Rhonda Voskuhl

Episode 189: Research on Sex Differences in MS Leads to Potential Treatment with Dr. Rhonda Voskuhl

MS affects almost 3 times as many women as men. Have you ever wondered why? When it comes to investigating sex differences in MS, my guest, Dr. Rhonda Voskuhl, has done more than just think about it. ...

12 Apr 202135min

Episode 188: Managing Your Cognitive Health in MS with Dr. Victoria Leavitt

Episode 188: Managing Your Cognitive Health in MS with Dr. Victoria Leavitt

More than half of all the people living with MS will develop problems with cognition. And while experiencing cognitive dysfunction can be challenging and frustrating, these kinds of changes can also b...

5 Apr 202131min

Episode 187: Progressive MS Research, Treatment, and Rehabilitation with Dr. Kathy Zackowski and Dr. Daniel Ontaneda

Episode 187: Progressive MS Research, Treatment, and Rehabilitation with Dr. Kathy Zackowski and Dr. Daniel Ontaneda

About 80% of the people with relapsing-remitting MS will eventually be diagnosed with secondary progressive MS. At that point, their remissions stop and their MS symptoms continue to worsen. And about...

29 Mar 202139min

Episode 186: Building Your Resilience with Dr. Meghan Beier

Episode 186: Building Your Resilience with Dr. Meghan Beier

Living through a lockdown can be challenging, and it's resilience that helps us get through life's challenges and recover from setbacks. And while resilience may have become a new topic of conversatio...

22 Mar 202126min

Episode 185: MS Advocacy and the 2021 Virtual Public Policy Conference with Bari Talente

Episode 185: MS Advocacy and the 2021 Virtual Public Policy Conference with Bari Talente

We're less than one week away from the National MS Society's Public Policy Conference. This year, the Public Policy Conference is virtual, which means that you have an opportunity to attend and learn ...

15 Mar 202139min

Episode 184: MS Awareness Week with Tracey Cooper-Harris and Sarah Quezada

Episode 184: MS Awareness Week with Tracey Cooper-Harris and Sarah Quezada

It's MS Awareness Week and we're talking with two remarkable women, Sarah Quezada and Tracey Cooper-Harris, who are living their lives out loud, refusing to let MS define them. We're also inviting yo...

8 Mar 202141min

Episode 183: Racial and Ethnic Disparities in MS with Dr. Mitzi Joi Williams

Episode 183: Racial and Ethnic Disparities in MS with Dr. Mitzi Joi Williams

When it comes to accessing care and even the disease course itself, MS is not an equal-opportunity disease. We're talking with Dr. Mitzi Joi Williams about the disparities that affect members of minor...

1 Mar 202131min

Bonus Episode: ACTRIMS 2021

Bonus Episode: ACTRIMS 2021

Welcome to a bonus ACTRIMS Forum 2021 episode of RealTalk MS. ACTRIMS is an acronym that stands for the Americas Committee for Treatment and Research in Multiple Sclerosis and this year, the ACTRIMS ...

27 Feb 202130min

Populært innen Helse

fastlegen
lydartikler-fra-aftenposten
rss-gukild-johaug
hvordan-har-du-det-mann
psykodrama
leger-om-livet
relasjonspodden-med-dora-thorhallsdottir-kjersti-idem
rss-garne-damer
foreldreradet
morten-ramm-lar-kakla-ga-til-du-sovner
rss-lopedrommen
klimaks
hormonelle-frida
g-punktet
hjernesterk
hverdagspsyken
sinnsyn
bak-fasaden-en-reise-i-livet-med-sykepleier-ine
helsetipspodden
rss-kull