Biotech Values

[DewDiligence]

ICPT—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. If they do, it'll be an extreme case of Zebra's Law.