Biotech Values

[DewDiligence]

Technically speaking, FDA had said lower confidence interval of 10% could be approved. Consider the size of these types of trial, that usually is 20% or higher actual number.

I agree with that—i.e. a 20% RR per se is not an FDA requirement in these kinds of trials, but it’s hard to exceed the mandated lower bound of the 95% CI with a lower RR.