But some of the FDA initiatives that Gottlieb want

But some of the FDA initiatives that Gottlieb wanted involved using fewer patients in the clinical trials, and using (anonymous) electronic medical records to form the control group -- so that in something like Bril-OM, everyone in the study could get the drug. When you have a large population that DOESN'T get it, they can constitute a great control group (even if it isn't a double-blinded study).

I read recently about some drug that was approved with just 32 participants in the drug arm of the study. Sorry, can't remember which drug that was.