Garry, only one party can make a change to the trial protocol and that is the sponsor (NWBO). The investigators and IRBs will need to concur, and if there is some problem the FDA can react with a hold. The DSMB is not in play.
Failure to unblind is not a change to the trial though. Patient treatment is not being changed. Investigators are following the exact same protocol they had been.
All this stuff about FDA this and FDA that is nonsense. The FDA allows a trial to be run. They do not run it.
But anyway, if decisions are being made based on blinded data as you assert, then:
. Why would NWBO want to change the SAP if it was working
. Why would it not be a huge issue with a post hoc change