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 249: The Ball Came Out with Tyler Campbell

Episode 249: The Ball Came Out with Tyler Campbell

In 2007, Tyler Campbell was a running back at San Diego State, looking forward to a real shot at a career in the NFL. Instead, Tyler's life was turned upside down by an MS diagnosis. For some people,...

6 Kesä 202228min

Episode 248: Pregnancy and MS with Dr. Annette Langer-Gould

Episode 248: Pregnancy and MS with Dr. Annette Langer-Gould

Starting a family is a big step for anyone. And when you're living with MS and you're on MS medications along with other symptom management medications, planning a family creates a lot of questions ab...

30 Touko 202232min

Episode 247: Biomarkers Can Help Diagnose MS, Predict MS, and Telegraph MS Progression with Dr. Tanuja Chitnis

Episode 247: Biomarkers Can Help Diagnose MS, Predict MS, and Telegraph MS Progression with Dr. Tanuja Chitnis

Think about how much faster, easier, cheaper, and less invasive it would be if MS could be diagnosed by a simple blood test. Scientists have identified biomarkers that can be used to diagnose MS and ...

23 Touko 202229min

Episode 246: The High Cost of MS Medications with Steffany Stern

Episode 246: The High Cost of MS Medications with Steffany Stern

When my wife was diagnosed with MS in 1997, the annual cost of her MS medication was $9,000. Today, the annual cost of that same medication is $110,000. We cannot allow the insanity associated with th...

16 Touko 202233min

Episode 245: The Journey to an MS Diagnosis with Dr. Michael Robers

Episode 245: The Journey to an MS Diagnosis with Dr. Michael Robers

For some, the journey to their MS diagnosis is relatively quick and straightforward. For others, it can be lengthy and convoluted, sometimes taking years. Joining me to talk about some of the twists...

9 Touko 202232min

Episode 244: Financial Planning For People Living with MS with Financial Advisor Dick Bell

Episode 244: Financial Planning For People Living with MS with Financial Advisor Dick Bell

Planning for your financial future is good advice for everyone. But when you're living with MS, financial planning is an important part of the game plan for living your best life. Joining me to talk ...

2 Touko 202229min

Episode 243: The Economic Burden of MS with Dr. Bruce Bebo and Bari Talente

Episode 243: The Economic Burden of MS with Dr. Bruce Bebo and Bari Talente

Living with MS is expensive. And if you're curious about how expensive living with MS is, why it's so expensive, and what can be done about it, then you're going to be interested in the results of a s...

25 Huhti 202230min

Episode 242: No Masks or Proof of Vax? Staying Safe in the Next Normal If You're Living with MS with Dr. Nancy Sicotte

Episode 242: No Masks or Proof of Vax? Staying Safe in the Next Normal If You're Living with MS with Dr. Nancy Sicotte

Mask mandates have mostly ended, and bars, restaurants, public buildings, and other businesses no longer require proof of vaccination. It looks like the COVID-19 pandemic is over. Except for the fact ...

18 Huhti 202234min

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