That all makes perfect sense @dplane now knowing from the documentation that the CRL is a formal/legal way of kicking the can down the road.
I've previously worked in the Federal bureaucracy for 16 years, and watching the Victorian public servants fumble their way through the hotel quarantine fiasco and the pandemic generally, if a public servant had an "escape valve" for all the pressure they are supposedly under, why wouldn't they take it?
Of course, the flip side (or SWOT) analysis should tell me that's only one of the plausible scenarios. But objectively, doesn't this all turn on how the COVID-ARDS Phase 3 trial is going to work out? The gold standard of the RCT, no FDA bureaucrat is going to have to sit down and burn the midnight oil on something they don't know much about.
But what's the chance that the DSMB are just taking another peek at their data now and seeing whether they can bring forward their Bayesian analysis to show some level of efficacy now that one DJT might badly need it in the next 7-10 days?
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