Search found 3351 matches

by J11
Fri Feb 04, 2022 9:01 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

https://evs.gs.washington.edu/EVS/ServletManager?variantType=snp&popID=EuropeanAmerican&popID=AfricanAmerican&SNPSummary.x=30&SNPSummary.y=10 Above is from the Washington Exome Server result for APOE. You can find the allele frequencies and other information for any SNP in the table ...
by J11
Thu Feb 03, 2022 9:06 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

Thank you for replying NF52. I am not sure whether it is good form to quote myself, though I think I will do this just to provide a scaffold to respond to your reply. J11 wrote: ↑Sun Jan 30, 2022 12:25 am ...I have been reading up on African American (AA) Alzheimer's. What is of great interest is th...
by J11
Wed Feb 02, 2022 8:31 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

I was unable to find SUVR results for the AMBAR trial or any other using albumin replacement. The search was more directed to looking at amyloid levels in CSF etc.; this research did seem to show amyloid changes. I read the first listening session from the CMS page and it was surprising how many of ...
by J11
Tue Feb 01, 2022 9:54 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

Hmm, looks like there is another phase 3 that was not included in my scatter plots. The AMBAR phase 3 trial reported a top-line positive with largish CDR-sb benefit in Moderate and Mild AD of from ~1-~1.5 points. As seen in the first figure on the right the MILD patients actually appeared to improve...
by J11
Tue Feb 01, 2022 9:46 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

AMBAR 1.PNG
AMBAR 2.PNG
Extra 4a.gif
by J11
Tue Feb 01, 2022 7:34 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

VII. Evidence B. Discussion of Evidence 2. External Technology Assessments CMS did not request an external technology assessment (TA) on this issue. I want to go through the Evidence section to review the logic that the CMS applied in its review process. One of the large controversies with the FDA ...
by J11
Tue Feb 01, 2022 7:14 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

In the last day or two the Down's advocacy community has stepped forward on the CMS comment page. Many of these comments express the concern that CMS will not provide coverage to those coping with Down's Syndrome. From my reading of the CMS document it is not especially clear what the CMS position i...
by J11
Tue Feb 01, 2022 6:43 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

Welcome to February! The positive momentum is building now for another round of FDA accelerated approval for Lecanemab and the end of Clarity in September. It is starting to get close! The submission for Lecanemab perhaps could be filed within a month. Once it's filed it will feel like the clock is ...
by J11
Mon Jan 31, 2022 9:05 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378621

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

So much to comment on. One of the more central points in many of the comments to the CMS comment page has been about the cost implications of Aducan for those on medicare. Originally the increase in monthly cost related to Aducan to those on Medicare was suggested to be $21.60 per monthly. However, ...