I really don't understand why people seem to think that keeping the current, seeming unfit for purpose, regulatory environment is desirable. They have already killed 10,000's of their own citizens, in my view. Whilst this is not yet a huge number in comparison with annual auto crashes, gsw, cancer & cardiovascular deaths in the US. It is still a chunk~
If the interim efficacy reduces mortality by say more than a few percent then I think they should approve, regardless of the damned statistical analysis...
For every 1% reduction 3333 * 0.01 = 33 people a day (231 a week) get to go home, plus improved QOL for some of the other survivors.
Given the established safety profile I just don't see the point in a transitional EUA for bureaucratic CYA maneuvering. I have no real insight into whether someone can / will get this sorted, I hope so but...
And maybe just maybe we will reach OE next week...
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