NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Protocol changes require only two things (in either order):

-Getting IRB approval of the changes, and
-Submitting proposed changes to FDA for review, then waiting 30 days before proceeding with said changes in the actual trial

Once you get both you're good to go. You don't need a response from FDA and usually don't get one. You can request dialogue but don't have to.