Purchase Summary

In order to access content on the FENIX Marketplace, you must have an account. You will also have access to FENIX Free updates.

The price for access is $599.00.


Account Information Already have an account? Log in here

LEAVE THIS BLANK

Payment Information We accept all major credit cards

By selecting this, I agree to receive emails from fenix.group.


You will be redirected to view the full article after purchasing. You will receive your account and payment information in a confirmation email, and can be viewed at any time in your Account.

Intercept Faces Uphill Battle for Impending FDA Adcom; Briefing Documents Released

Here is a brief preview of this blast: Briefing documents have been posted (view here) for FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to discuss the use of Intercept’s obeticholic acid (OCA) for the treatment of pre-cirrhotic liver fibrosis due to NASH. For context, the OCA adcom is on Friday, May 19, 2023 (previous FENIX insight). Recall, in January 2023, FDA accepted the NDA for OCA seeking accelerated approval as a Class 2 resubmission and assigned a PDUFA date of June 22, 2023 (previous FENIX insight). Of note, Intercept's stock price decreased as much as -22% in intraday trading following the release of the briefing documents. Below, FENIX provides insight into the potential outcome of the OCA FDA adcom.

About The Author

Matthew Maryniak

|
President of Fenix Group International
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.