I don't believe that most second Phase 3 Trials the FDA has often insisted on were necessary, but the FDA doesn't seem to mind spending other peoples time and money to be absolutely certain of something a blind man could see.
In some ways I can be happy about their unwillingness to recognize the obvious, if they had, this trial would have been over before I ever heard of the company, and I'd certainly not been able to get in for under a quarter.
In this case, if the FDA were to ask for another trial they'll be the laughing stock of all the other regulators chomping at the bit to approve the vaccine once they're given a chance to review the BLA. I make no secret of being critical of our FDA, but well over 50 people had to live beyond 5 years for the median survival of the Top 100 patients in the trial to be over 7 years, that's at least 3 to 4 times what the SOC would have provided. Dr. Liau's comments about the Top 100 living near 5 years made in 2019 should have been worthy of consideration of an early approval.
I know I think that things should be looked at more simply than any of the regulators do, people living much longer than they're supposed to be tells me all that I need to know.
Gary
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