Almost a textbook case of how to get into trouble with the FDA: issue an optimistic press release based on partial data when the FDA has the full data, quote a higher efficacy than the FDA gets in the full data, ignore DSMB instructions on stricter calling of COVID-19 positives, and do all of that without prior notification so it takes the FDA by surprise.
The vaccine looks pretty good; the management’s communication… not so much.
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