Intercept Pharmaceuticals (ICPT)

[DewDiligence]

NASH doubletalk from ICPT:

https://www.globenewswire.com/news-release/2021/07/29/2271107/23024/en/Intercept-Pharmaceuticals-Reports-Second-Quarter-2021-Financial-Results-and-Provides-Business-Update.html

“We continue to make progress on our development program in NASH fibrosis… Since the beginning of 2021, we have had frequent exchanges with FDA to gain alignment and feedback on safety, biopsy methodology and efficacy data. We have now gained enough insight from FDA in these critical areas to move forward on our plan, and with the right team in place, we have begun to generate what will ultimately be the largest data package ever produced in the NASH field. We will be evaluating available data internally to inform decision-making and expect that process to continue into the early part of next year, with a goal of holding our pre-submission meeting to review the data with FDA during the first half of 2022.”

Right.