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plexrec
Blarcasamine
After reading this well written piece I understand better why AD is where it is. Like me, many here may have spent long days in conference rooms w/long debate tables lined by topic-subject experts . "We get it", not everyone sees the argument with the same (eyes, wisdom, reasoning, background, education and precision ....and...they never will).
In fact I bet many here have witnessed fine-line long debates that proved absolutely nothing except two individuals do not like/understand each others point of view, and they never will. Can we just move on? In some cases these hopeless debates in trivia are relegated to resolution by some use of statistical reasoning, which typically resolves nothing. (sound FDA -like familiar to anyone?).
This is where a favorite old Irish expression of problem solving is applied ...,"Unconstrained by knowledge, we moved on."
Not a surprising conclusion. In fact, it explains a lot. Why else would people like Dr.M. avoid the established system when he is holding a full CNS house. IMO, b/c he knew the game is rigged/stacked/corrupt. This is also consistent w/last few years of FDA open corruption and dysfunction.
Maybe now we can all move on.
Thanks falconer.
HMB2010
jonjones325
jonjones325
traderpete
Imagine that you are a passenger on a bus. You bought your ticket based on the sign on the front of the bus . (CNS disease AD, PPD, Dementia, ...see posted plans/schedule), so you find a seat and look out the window at all the helpless pedestrians staring in wonder as their lives go by. You may take some comfort in the thought that (at least you are ON the bus), you can get off anytime you want.
There seems to be a lot of angst and turnover but the driver appears not to be distracted. He acts like he has enough time and money to finish his plan (traffic-accidents not with standing). He suggests from time to time he is getting close to the final stop but then he just drives right past the clinic. Passengers start yelling about the schedule, to which the driver simply asks..."Do you want to get OFF??" . If Yes, he stops and then....bye, bye.
Bus is getting crowded again. We each have to decide , either get off, sit down and STXU, move around and continuously make life tougher than it has to be or have some confidence you have continued to make the good-right choices. BTW, life is short, then you die.
Please send link to this doc...no joy looking so far...TIA
Wolfof
By my count, this happened about 100 years (+/-) too late to save whatever is left of the FDA.
@adamfeuerstein
·
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EXCLUSIVE --> Biogen’s $BIIB Samantha Budd Haeberlein, an architect of Aduhelm, leaves company https://statnews.com/2023/03/12/biogen-samantha-budd-haeberlein-leaves-company-aduhelm/
Her departure comes two weeks after Billy Dunn left the FDA.
statnews.com
Biogen's Samantha Budd Haeberlein, an architect of Aduhelm, leaves company
Samantha Budd Haeberlein, the Biogen senior executive who supervised the development and controversial approval of the Alzheimer’s treatment Aduhelm, has left the company, STAT has learned.
12:01 PM · Mar 12, 2023
Joseph K
Hoskuld
attathehunt
Excellent work SOKOL
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://79bcf7a1-8b8e-483b-b7cf-f5c5192a6d63.usrfiles.com/ugd/79bcf7_c5813c517d9f4ca5aacbeb719508827a.pdf
In other words, Blarcamesine restored dysregulated genes associated with Alzheimer's and Parkinson's. If so, was that restoration evident in all patients treated with Blarcamesine versus no restoration in the placebo patients? More importantly, did all treated patients show some degree of improvement or decline in the progression of the diseases? Or was it that the restoration occurred only in those patients treated with the Blarcamesine high dose?
It's all about connecting the right DOTS.
Agree w jonJ...a clear message of AVXL leadership which would not(could not) be sent w/o strong-credible science and clinical evidence support.
Hey, WHAT COLOR IS THIS RED PIECE OF PAPER????[b[/color]
GREAT NEWS TODAY!!!...georgejji
https://www.anavex.com/post/anavex-life-sciences-appoints-former-fda-lead-neurology-statistician-as-vp-head-of-biostatistics...
Agree, this should be seen as good news. Any thoughts on why (someone-Mr. Market) has not shown a positive or at least not (sp) negative reaction?
attilathehunt SeeEE??? You were right...
attlathehunt
abew4me
10.00+0.07 (+0.70%)
As of 11:50AM EST. Market open.
Any idea what this is worth? Supporting WW info?
Well Done:
Some day soon we will get notified to man our battle stations. Be ready, there will be no warning. It is an experience you will never forget.
georgejji
Got to love this thinking: IMO, WAY OUTSIDE THE FDA AMYLOID BOX.
https://mail.aol.com/webmail-std/en-us/suite
Very powerful stuff. Thanks for the direction-contribution...BTW, your mental model description is consistent w/work done by Dr. Peter Senge, MIT. Ref his books, example , "The Fifth discipline.". We are all about how systems form, interact and present themselves, if we know where to look and what we see/not see.
IMO, your text is exactly consistent w/understanding biosystems interactions and how lay people (like me) can make the leap from conventional medical (fix my broken leg) thinking to systems thinking applied to how BIO-MED CNS links interact and function. Fixing the Bio-Med break does not work in CNS, by itself.
IMO, S1R links-thinking is the closest thing to a CNS Silver Bullet I have seen yet. WGT.
I would like to see the (@ least Bi-Weekly) status updates on all program/trial goals and results. In other words, it is just not acceptable that we, "discover" , after the fact that a major program goal or trial has gone un (or under) reported by any CRO. IMO, that is management responsibility 101. . Let us know when it happens [u]not months later.
9.44-0.24 (-2.48%)
As of 09:56AM EST. Market open.
TOTAL B.S. thieves at work
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167374/
Very impressive stuff here georgejji. Ducks are getting in a line. WE ARE DUE.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/94074/download
Quality System Regulation Definitions 21 CFR 820.3 (z)(1) Process Validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications
kevindenver