The “one-half treatment effect” standard you cite for the non-inferiority delta is rarely applied in practice. It is generally overridden by whatever specific agreement the sponsor has with the FDA on the non-inferiority delta.
>Would GTCB have discussed the NI delta with the FDA before hand?<
If they did not, they would’ve been astonishingly incompetent, so I presume the answer is yes.
A corollary of the above is that the historical DVT rate for this patient pool on placebo is essentially immaterial to the outcome of the trial.
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