I thought the FDA didn’t look at interim results unless the DSMC asked them to, but we know they are looking based on what the doctor said at conference. Also, Dr NP said the FDA wanted to see the interim results last week on Fox News Business. Does FDA always look at interim results or does this mean DSMC found something positive about the trial and wants FDA to confirm?
Also, I’ve read we have to be .05 for an interim halt, .029 for an interim halt, or that an extremely good p value doesn’t necessarily matter for a halt as long as safe and effective because this is a pandemic. Which is closest to correct?