Biotech Values

[DewDiligence]

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.