Celebration Thread! Biogen is going to the FDA with Aducan.

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Fc1345linville
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by Fc1345linville »

"House Investigation faults FDA and Biogen forAlzheimer's Drug Approval" Dec. 29 at 1;52PM

Lock 'em Up.


https://mail.google.com/mail/u/0/#inbox ... XdXSfFvTDs
J11
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Yeah 2023!
I can't wait to see what the new year will bring us!

Happy New Year everyone!
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Fc1345linville, thank you for your comment.

I will however have to disagree with you.

A family member in every single generation of my family for centuries has been affected by dominant Alzheimer's dementia. When I thought about that statement, I wondered how could that possibly be possible. I mean that means we hit dementia bingo generation after generation after generation. We are the line that have never missed a generation. It's like one of those bouncing balls that keeps bouncing right- every time. Do they give out prizes for the most unlucky outcomes. I mean sure someone will hit the jackpot, though why don't they award someone who hit the anti-jackpot?

When I talk to even nearish family they often have no idea about dementia at all. It's just that we have scored the dementia jackpot every single time-- yea! I suppose that's how it is with all dominant illnesses. Clearly genetic selection now gives us the chance to stack the deck in our favor: All we need is one generation in which we don't hit dementia B-I-N-G-O and we are set.

It is so disheartening to read back in the family and realize how they too were struggling with dementing illness. The earliest family record that I have encountered is a court transcript in which they transported children from the family to a penal colony for the crimes they had committed. Basically, my family has been part of an eternal dementia underclass. I was thinking last Christmas that I should give to the less fortunate, when I thought about that I realized WE are the most unfortunate. I suppose I should have passed around the collection jar while I still had a chance, though I forgot. In the next few days when the FDA decision is made, I guess that means I'll have to wait an eternity to have another chance for a full jar. I guess that means that from here on out I will be the one dropping coin in the jar; it will be great to be able to help others and not need their help.

Dominant dementing illness puts you into the position of never having a realistic chance of escaping the fate of your genetics: a Sisyphusian struggle against neurodegeneration. It feels now that we could in one generation launch out from the margins of society and soar upwards. Perhaps a fair amount of the homeless/unemployable/etc. group who might also belong to the broad neurodegenerative life experience will be lifted up as well.

We are now days away from a decision that could finally allow us to break free. I'm about to call it Alzheimer Liberation Day 3. It will be a triumphant moment for us. This is history everyone; polish your shoes-- this is big. There are tens of millions of people currently coping with clinical AD and so many other hundreds of millions who are in the worried well category. From best I can tell this is the medical breakthrough of the century.

I am very unclear why it is thought sensible to consider arresting the people who have brought so much hope and promise to so many desperate dementia families. I have been thinking about what the screen play for this biggest story ever told might be and how the congressional investigation could fit in. My best guess as of now would be to simply edit all of that out because it is so out of step with the celebration that might now be only days away. It is very odd how often the people who are at the forefront of technological revolutions are the same ones who need good criminal defense attorneys.
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

They have posted the abstracts of CTAD 2022!
https://www.ctad-alzheimer.com/


I thought ... why not remix it?
Yeah!

Hope you like it.
With the flat pdf file format it is so ... so ... flat.
However, you can start to jazz things up by adding in graphics, comments, cross-references etc.
Basically, remix the original format and make it more vibrant.
I have not added in Clarity slides etc. because I have actually not been able to find the Clarity reference?


When you remix it it allows you to quickly find what is important.
Follow the hints to the index and then when you click on the magenta hyperlinks you get right to the good ones.
I also have included a few Wows that really caught my eye.

To read the below link download LibreOffice (for free, if needed).
CTAD 2022.odt
For some very very odd reason the Clarity result does not appear to have been included in the pdf???
Very unsure why not.

Comments please!

{Hmm, funny it opens on page 115 for me. Will have to scroll back to start where the formatting is.}
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J11
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Has anyone queried GPT chatbot (the infinite intelligence AI program) about Lecanemab?

(For some reason I am being locked out of the system. No heretics allowed.)

Does anyone know how to get a news ticker that will announce the Lecanemab exactly when it is reported?
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by NF52 »

J11 wrote: Thu Jan 05, 2023 10:50 am Does anyone know how to get a news ticker that will announce the Lecanemab exactly when it is reported?
You can subscribe to immediately get FDA press releases with your email here: FDA press releases
4/4 and still an optimist!
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Thank you very much for your reply NF52.

The FDA decision is now rapidly approaching.
This is overwhelmingly exciting.
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Clarity 2a.png
Clarity 1a.png
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

Clarity 4a.png
Clarity 3aa.PNG
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Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Post by J11 »

I think it would be very helpful to go through the Clarity slides on safety REAL slow so that I can understand what is happening.

It is just that when they ran through the slides at CTAD there were a few of the finer points that escaped my attention.
Probably the biggest miss here was from the first slide in the post directly above. I highlighted a fatality in the placebo group in red. What is of interest is that this placebo fatality in the core of the Clarity study was the only intracranial hemorrhage leading to mortality. They wrote this all in small print and did not highlight this fact. In terms of scoring rhetorical points, this would have been a good one to emphasize. The only patient in the core study who had a fatal intracranial hemorrhage (macrohemorrhage) was on placebo?

In the slide directly above I again boxed this patient in red; this time there is more detail given-- this placebo patient actually had a macrohemorrhage while in the core study. To the right there were 2 patients in the OLE who also had fatal macrohemorrhages, who were on anti-coagulants. there is some uncertainty here for me because the article published in NEJM yesterday stated that the 65F e44 OLE patient who experienced a MCA stroke WAS NOT on anti-coagulants. this slide to the right boxed in blue clearly states that the patient WAS on anti-coagulants.
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