Biotech Values

[DewDiligence]

ICPT—You are thinking of an outright rejection or very restrictive labeling? If you had to guess a probability number, what would yours be at?

I’m referring to the FDA advisory panel for Ocaliva rather than the FDA decision per se.

Advisory panels discuss label-related issues, but they don’t typically undertake a formal vote on the label. On the main question of whether the FDA should approve Ocaliva for NASH, I would say there’s only a 25% chance that the panel endorses Ocaliva by a 70/30-or-better margin.