Search found 3351 matches

by J11
Mon Jul 05, 2021 8:43 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

This is another quote about the correlation issue (Page 130). The idea here is that you can randomly assign patients to group dose groups yet it is not as obvious how to randomly assign patients to SUVR amyloid reduction values as the trial is underway. In fact it is understood that various covariat...
by J11
Mon Jul 05, 2021 8:08 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

Thank you flora for commenting.

Yes, it seems that much of the argument against aducan evaporates once grown-ups take a look. Go grown-ups!
by J11
Mon Jul 05, 2021 8:06 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

Yeah! I was worried that I would not be able to find this one again. This shows the covariates in the 302. First notice how there is only 8% in the >=75 age category in sub-group 4 SUVR (0, -0.16). Yet, >=75 were the patients that did much better than average: they loaded up sub-group 4 with patient...
by J11
Mon Jul 05, 2021 7:56 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

The above figure shows the lack of correlation. Yet, the points highlighted in pink show points that have leverage which might be related to covariates such as APOE- genotype. We saw earlier how only even single points could substantially influence the slope of the regression lines. The red line is ...
by J11
Mon Jul 05, 2021 7:28 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

There's lots of exciting aducan research still to discuss! The FDA has posted more internal aducan documents that help to clarify a number of issues that I had not been clear about. The clinical pharmacology report is especially increasing and section 4.5 page 134 helps to resolve three of uncertain...
by J11
Mon Jul 05, 2021 6:55 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

Thank you for commenting JulieG. Yes, the price would clearly be more affordable on placebo. I just had not thought of AD as a reversible illness. In our experience AD is relentlessly progressive over decades into profound disability. I suppose this is what could be called selection bias or first pe...
by J11
Mon Jul 05, 2021 6:46 pm
Forum: Prevention and Treatment
Topic: Celebration Thread! Biogen is going to the FDA with Aducan.
Replies: 1808
Views: 378172

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

The above post shows a comparison between ARIA and other side effects between the leca phase 2 and the aducan phase 3s. In the recent FDA documents it was noted that 44s had ARIA rates ~60%. What is remarkable in the above figure is how much lower ARIA is with leca. There was 0 ARIA in APOE- s even ...