Ending the War on Saturated Fats ๐คฃ๐
realfood.gov
@michaelwheelson.bsky.social
Mechanical Engineer. Star Wars better than Star Trek. Agnostic Atheist. Oklahoma Blue Dot. ALS'ing since Feb. 2017.
Ending the War on Saturated Fats ๐คฃ๐
realfood.gov
Yes, they flipped the food pyramid just like the South Park episode. Somewhere Cartman is screaming โI told you soโ 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. ๐ซฃ
26.11.2025 19:51 โ ๐ 1 ๐ 0 ๐ฌ 0 ๐ 0My 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.
26.11.2025 19:21 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0The latest ALS Focus survey on Health & Wellbeing is open until Nov 14.
If youโre 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"
29.09.2025 20:32 โ ๐ 1 ๐ 0 ๐ฌ 0 ๐ 0Social media data can be informative, but extremely limited.
18.09.2025 18:32 โ ๐ 0 ๐ 0 ๐ฌ 1 ๐ 0FDA 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.
So there blaming the Citizen's Petition on lack of trial funding and falling off the NASDAQ?
15.08.2025 00:06 โ ๐ 2 ๐ 0 ๐ฌ 1 ๐ 0This isnโt just in a galaxy far, far away.
18.07.2025 19:42 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0"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
๐คฃ๐คฃ๐๐
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.
15.07.2025 22:02 โ ๐ 1 ๐ 0 ๐ฌ 1 ๐ 0Did 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 hasnโt misled you into thinking you know something you actually donโt 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 arenโt enough when there is ZERO accountability!
24.06.2025 00:35 โ ๐ 0 ๐ 0 ๐ฌ 0 ๐ 0Very exciting series!
23.06.2025 15:09 โ ๐ 1 ๐ 0 ๐ฌ 0 ๐ 0