I have a recording made Sept 2, 2020 on my iPad, I don't remember the context, GK is speaking at some conference. This is what he says about the data release:
"... and we will then be told what the results are and then per the SEC regulations we will very quickly tell you guys, but honestly I'm gonna tell FDA 1 day before. So, sorry to tell you that." Then he goes on about standard of care.
I've wondered this myself, why the need to tell the FDA 1 day before the PR? You don't just send it to the FDA inbox, there has to be a person(s) that he wants to see the results first. My guess, and it's just a guess, it's kind of a victory lap. In 2016 the FDA told CelSci to put the trial on hold, the 10K from September 30, 2016 has all the details.
Success would be the sweetest victory!