Choosing to not take any of the suggestions for faster testing for safety / efficacy (human challenge trials) but instead choosing to decide that the multi-year long process was the only possibility *was a choice by FDA*. They chose delay - passive resistance.
The evidence is that they took 11 months (with a multi-week delay for no reason at all at the end just 'cause their next regularly scheduled meeting wasn't for a few weeks) rather than 6 weeks. If they tried to take longer, they would have lost the ability to block it at all.
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I ask again, what’s the counterfactual
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