Intercept Pharmaceuticals (ICPT)

[DewDiligence]

FDA_advisory_panel_votes 15-1 against accelerated approval_for Ocaliva in NASH:

$ICPT VOTE on Q4
1-a
15-b pic.twitter.com/H4nkmYydmQ

— FDAadcomms (@FDAadcomms) May 19, 2023

In a separate question for the panelists asking if the benefits of Ocaliva outweigh the risks in F2/F3 NASH, the vote was 12-2 against with 2 abstentions.

I’ve posted many times that Ocaliva is simply a bad drug for NASH that should not be approved for this indication—e.g. #msg-169362197 and #msg-170082971.

After today’s vote, I’m skeptical that ICPT will continue its clinical trial to the final analysis for measurement for hard clinical outcomes.

p.s. The stock is currently halted.