Biotech Values

[DewDiligence]

Re: AD clinical_trials_in_a_post-Adu-approval_environment

…at least one of the two typical AD trials will need to be against placebo…

If the FDA approves Adu, I’m not sure it will be possible to conduct a US trial of another AD drug using a placebo arm. A placebo-controlled trial might be doable if all of the trial sites were international, but such a restriction raises its own problems.

As it is, placebo in AD usually means donepezil or other AChEI.

I doubt that those drugs would be considered acceptable for control arms in a post-Adu-approval environment.