And I think add this every time we have a big drug trial wipe out: keep in mind, that under a safety-only regulatory regime, that people would have been taking this drug (and paying for it, one way or another) for the last few years now, and it would have done them no good at all. When they could have been actually taking something that might help them. We do not know enough about investigational drugs to approve them without efficacy data.
If you're a biostat anywhere, public or private, the Gottlieb cabal isn't your friend. But you've read that sort of thing here before. Quant in the various venues of human rule making (FIRE, in particular) is less useful than reading the NYT. But quant dealing with God's Laws is another matter altogether. There's real value there. And the CxO brigade would just as soon not have to prove their compounds and devices actually benefit patients.