America's New Dietary Guidelines The Dietary Guidelines for Americans reset U.S. nutrition policy by restoring science, common sense, and real food as the foundation of national health.

Ending the War on Saturated Fats 🤣😂

realfood.gov

Flip the Pyramid - South Park | South Park Studios US In the midst of the gluten crisis, Cartman calls the USDA with a crucial piece of information.

Yes, they flipped the food pyramid just like the South Park episode. Somewhere Cartman is screaming ‘I told you so’ through a mouthful of bacon.

southpark.cc.com/video-clips/...

Here is the response letter:

drive.google.com/file/d/12tcs...

FDA provided interim response on Dec 11 to Nurown Citizens' Petition. It states they need more time, so not looking like they will make this month's deadline.

www.regulations.gov/docket/FDA-2...

Yeah, that's fair for sure. 🫣

My wife's private practice has a consent form that explains it and the purpose for using it. Saves so much time for documenting and allows her to focus more on the patient during the session instead of trying to take detailed notes at the same time.

The latest ALS Focus survey on Health & Wellbeing is open until Nov 14.

If you’re living with ALS, caring for someone with ALS, or a surviving caregiver, would love for you to share your perspective at alsfocus.org

Survey Challenge

Hey ALS/MND peeps! Quick mission for you as I know how much you enjoy clicking buttons. Please take this 2025 Fundamental Rights Survey for people with ALS/MND, caregivers, and blood relatives. Open to all around the world.

survey.alchemer-ca.com/s3/50360855/...

More like "conservative guys over 40"

Social media data can be informative, but extremely limited.

FDA Patient-Focused Drug Development: Workshop

COI - Concepts of Interest
MAH - Meaningful Aspects of Health
COA - Clinical Outcome Assessment

Takeaway is FDA very interested in including patient experience data, but is very challenging. These should be part of trial design.

a man with a mustache is making a funny face and saying i 'm biting my tongue . ALT: a man with a mustache is making a funny face and saying i 'm biting my tongue .

Some days this is hard

seekingalpha.com/news/4485598...

So there blaming the Citizen's Petition on lack of trial funding and falling off the NASDAQ?

This isn’t just in a galaxy far, far away.

"Of all the things at risk, the loss of an objective reality is perhaps the most dangerous. The death of truth is the ultimate victory of evil. When truth leaves us...we become vulnerable to the appetite of whatever monster screams the loudest."

- Mon Mothma, Andor S2E9

Maybe we can find someone to bring in some drama!?

@lynnbr2.bsky.social @alsadvocacy.bsky.social

🤣🤣😂😅

So NfL is listed as pre-specified key secondary endpoint for Tofesen in clinical trial site. NfL not listed on site for Nurown, but is in SAP as pre-specified other secondary/exploratory endpoint. Not sure if FDA weights those differently, but I think the %NfL drop between the two was biggest thing.

ChatGPT - NurOwn Approval vs Cancer Drugs Shared via ChatGPT

Did a deeper dive and added this article:

-Seems virtually all AA are based on pre-specified surrogates, not post-hoc alone. Including all from Table 2.

-Some cancer drugs were approved without confirmatory trials already underway, but this was the minority.

Full chat: chatgpt.com/share/687692...

ChatGPT thoughts...

chatgpt.com/s/t_687691d7...

The real purpose of the scientific method is to make sure nature hasn’t misled you into thinking you know something you actually don’t know.

- Robert M. Pirsig

Cassidy was the deciding vote to confirm RFK Jr. based on a promise not to fire the panel. Maybe confirmation promises aren’t enough when there is ZERO accountability!

Very exciting series!