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by J11
Wed Nov 10, 2021 7:54 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

It is difficult posting about aducanumab given the recent fatality, though I want to try and engage with this in order to understand some of the features involved. I have downloaded the FDA summary of the reported adverse effects for aducanuamb. Notably the two previous fatalities which happened in ...
by J11
Wed Nov 10, 2021 7:44 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

The recent fatality associated with aducanumab has motivated me to think about my own personal perception of where we are with anti-AD treatment. My perspective is that now that an anti-amyloid treatment has been approved (i.e., aducanumab) I will never personally experience the Alzheimer's that has...
by J11
Tue Nov 09, 2021 8:50 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

The FDA's adverse reaction page is reporting a fatality for aducanumab. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard This will be difficult for those trying to obtain the best care for their loved ...
by J11
Tue Nov 02, 2021 6:19 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

Flora, thank you for your encouragement. It already feels a long way away from the June approval of aducan. It is such a great relief for me to know that effective AD treatments will be available to me and the AD dementia community (i.e., for those well ahead of their age of expected onset) far in a...
by J11
Fri Oct 29, 2021 10:02 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

SusanJ, thank you for posting your anniversary congratulations to the thread! My basic hunch is that pharma is going to offer the non-symptomatic patients a very compelling value proposition. To date it has been all about "maximal wealth extraction" etc. and that is not overly helpful. Wha...
by J11
Tue Oct 26, 2021 9:05 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

Sometimes with anniversaries the most important part is the relief felt that it was remembered and that one could avoid the dog house. Yet, with this 2 year thread anniversary, I think it should be more of a week long celebration than remember and move on. The progress made in the last 2 years towar...
by J11
Mon Oct 25, 2021 6:27 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

Happy Second Thread Anniversary Everyone! It has been a great 2 years for the thread and for Alzheimer's clinical progress. 2 more years! 2 more years! This has all been the warm-up for the party. We could now be moving more from the party planning stage to the party celebrating stage. I am greatly ...
by J11
Wed Oct 20, 2021 7:09 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

There is some big news about the breakthrough designations. I suppose it is not so much news per se but a clarification. An article on alzforum today noted that Clarity is a C-O-N-F-I-R-M-A-T-O-R-Y study. I had some reading comprehension problems with CONFIRMATORY. Just as aducanumab is supposed to ...
by J11
Tue Oct 19, 2021 7:23 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

One of the ideas from an earlier post that I want to explore further is the "invisible hand" that has been at play with aducanumab and the anti-amyloid treatments. Adam Smith's "invisible hand" from economics for a student can be perplexing to divine its meaning. Clearly, one exp...
by J11
Mon Oct 18, 2021 8:42 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 774
Views: 88668

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

NF52, I had this half-formed memory about enrollment in China being somewhat odd. Here it is. The url below is the Clarity trial. Here is the odd part scroll down to the History of Changes. Notice how on the April 8, 2021 Submitted Date that many clinical trial sites for Clarity opened in China. Wha...

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