Execs from Madrigal, Cirius and Axcella say the FDA’s complete response letter is specific to shortcomings of Intercept’s OCA – and leaves the race to be first to market wide open again.

With approval timeline for OCA now thoroughly unclear and Genfit on the ropes, might the top spot in NASH end up with Galmed, AbbVie, Madrigal, Inventiva or Gilead instead?

Rather than expose patients and others to SARS-CoV-2, Provention opted to pause a Phase III type 1 diabetes trial. Addex and Iveric have since delayed trial initiations and more studies are likely to be impacted as coronavirus concerns mount.

There are strong reasons to justify an advisory committee meeting for the NASH application, but also an outlet for the US FDA to skip it.