Biotech Values

[DewDiligence]

ICPT—I wonder which part of trial requirements came from FDA, which part came from EMA? Maybe ICPT wanted to jam requirements from both agencies into one trial. Maybe they'd be better off by conducting two separate trials to satisfy each agency rather than jam two into one tough single trial.

Alternatively, they could have run another phase-2 (using the phase-3 endpoints) for confirmation before committing to a design monstrosity like REGENERATION. That’s what a Big Pharma would almost surely have done.