TSOI - Those are some damn good points
It's also basics of CT design. Participants in a CT keeping a diary of whether they had the sniffles on day 23 or not proves nothing.
When they are testing drugs for Covid, they also test for the presence of the virus.
When testing vaccines, they will test for Abs produced.
In neither case are they going to base conclusions on participants keeping a daily diary. Of course keeping a diary is far cheaper for TSOI that giving patients weekly antigen tests X 500 patients, costing $1K/test.
Basically the FDA flocked up in approving the TSOI IND, with these endpts. The probability they will approve based on such endpts is nil. One would hope.
The Jewel of the Mind is Colored with the Hue of what it Imagines