Why did Pfizer and FDA agree to not release the news of the vaccine's success in October as the original protocol of a 32 -case interim analysis would have required? From StatNews:pic.twitter.com/s1XrgR3kDq
Not to be confused with 2001 Nobel Peace Prize winner Kofi Annan. 54th Clause of the Magna Carta absolutist. Commentary from an NRx perspective.
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Why did Pfizer and FDA agree to not release the news of the vaccine's success in October as the original protocol of a 32 -case interim analysis would have required? From StatNews:pic.twitter.com/s1XrgR3kDq
with so much public interest riding on a successful vaccine, no surprise that they imposed a higher confidence level of testing than usual.
Shutting down their laboratory processing of samples until the day after the election, by which time they had almost three times the samples they needed, definitely increases confidence.
It looks bad from the way the report was written. but there's a gaping hole in that "discussion with the FDA" part. What were the FDA concerns? A good report should have covered that critical part. Now this just leads people to jump to scurrilous conclusions.
The FDA's concern was that it would interfere with the Biden campaign
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