RE:Respectfully disagree on "cheap financing" comment
I know that you will consider this bashing and don't necessarily disagree with you but "...take full advantage of the brand new ( and likely for us ) FDA device fast track.." is very much like your pronouncement that the FDA would could put an early stop to the trial because of the information from Italian/ French/other trials.
This is not a slam dunk, as I've said before. Sounds good but this is the FDA!!