The problem is the SAP is how the trial will be judged, the criteria must be established before the trial is unblinded. I know the regulators can play games, and perhaps if it's accepted by a majority the company should just do it, but only if one regulator is clearly just playing games.
I believe we're well into the home stretch, it would be a shame to stumble just before the finish. I think we should let the company do what they believe is right, if it takes a little longer, so be it. We know a lot of people in the trial are still alive, I don't believe it's possible to ignore this fact, and even if the trial had some problems, it's impossible not to conclude the vaccine saved lives and that should warrant approvals.
Gary
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