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swampboots

05/29/21 8:55 AM

#238190 RE: swampboots #238189

In my humble opinion, thinking about that editorial, it is probably the most consequential editorial by a notable doctor on a FDA panel, I have ever heard about.
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DewDiligence

05/29/21 12:24 PM

#238192 RE: swampboots #238189

Re: Aducanumab op-ed

Further to the arguments in the NYT op-ed, FDA approval of Aducanumab would have a deleterious and cascading effect on the clinical development of safe and effective AD drugs.

Some phase-3 trials of subsequent AD drug candidates would likely have a goal of showing non-inferiority to Aducanumab, and such a soft endpoint could enable cascading FDA approvals of AD drugs that have no efficacy whatsoever.

In short, FDA approval of Aducanumab would be a categorical disaster, IMO.