Biotech Values

[exwannabe]

ONTY: OK so he was referring to the total alpha of 0.025. Is that one-sided or two-sided?

I have always thought it was 2 sided, and this CC should end that discussion. But never knew the exact reason why the FDA imposed it as a requirement for the SPA.

Is this always the case, if one wants a SPA on a single trial the FDA wants to see a lower P?

Or was this partially because the P2 data was statistically bad (in combo with the single trial)?