Sunday, May 23, 2021 11:38:37 PM
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!
"... 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!
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