The FDA don't give any guidance on what "OE" means.
That's because "OE" is a DSMB concept, not an FDA concept.
It is clear that for normal FDA approval on a single trial 0.05 isn't sufficient.
The FDA aren't clear on the required value for a single trial.
The most common values are 0.001 or 0.00125, but they can be persuaded to be less stringent.
As for EUA, the FDA efficacy criterion is "may be of value".
The FDA don't give any guidance on what "OE"...
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