IMO, if we get p
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IMO, if we get p <= 0.05, we would get full approval. If we get something slightly larger such as p = 0.06, we could still get an FDA EUA depending on some strong stat sig results on secondary endpoints as well as consideration from other nations.
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Agreed. The demand for mortality reducing therapeutics couldn't be higher. I think its easy for us to rationalize reasons why this may fail, but I would argue that in my lifetime (and perhaps the history of the human race) there has never been a larger imbalance between supply and demand for any product.
This delta will cause things to happen. Probably more than we can even currently imagine.