Biotech Values

[DewDiligence]

BIOD—The FDA does not allow post-hoc data exclusions for centers with tainted product because doing so would bias the results in favor of the experimental drug—the assumption being that the trial sponsor is less likely to reveal a corresponding problem in the comparator arm that would help rather than hurt the statistical outcome. This is the same reason the FDA does not accept post-hoc data changes that help the outcome even when the changes are corrections to clerical errors.

In short, the argument in the Seeking Alpha piece about why the Indian data should have been excluded is not well founded, IMO.