cityslicker/bear ... I realize a Covid P3 will be needed if Covid P2 looks goood enough to move forward. I also get blinding a critical study for purity and reliability of data, traditional standards.

However, if the testing results will actually be based on clinically measureable changes in "biomarkers" data through clinical testing, effects, outcomes, why does blinding the study rather than open label matter for reliability and confidence in the data?

I would totally get it "if" the results were based on subjective criteria such as "do you feel better?" or doctors making claims based on their personal and potentially biased observational experience within a study. Just curious, from the scientific viewpoint?

Regarding "p" values for the study data, are there modifier calculations baked into the study confidence/reliability and "p" value calculations if a study is open label? Or, is it just a case where the governing body (FDA?) sees the data and "p" values as they are but then says, well the data looks great regardless of labeling, but let's do it with closed label (single/double masking) to ensure objectivity and remove any doubt whatsoever whether "opinion/subjectivity" potentiially exists within the data? In other words, thus making the data impeachable and beyond reproach from any possible conceivable avenue of bias, while the data and "p" values remain under standard calculation/evaluation regardless?

Just curiosity regarding study process and evaluation, thanks for entertaining the questions!