Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Will A US FDA Advisory Committee Be In Intercept's Future?

Executive Summary

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.

You may also be interested in...



Intercept CRL Likely About OCA-Specific Concerns, Not NASH Endpoints

The US FDA complete response letter for Intercept’s obeticholic acid raised speculation that the agency might be rethinking approvable endpoints for NASH. But analysts generally think OCA’s unspectacular efficacy data is behind the decision.

Intercept’s NASH Drug Delayed By April Advisory Committee

US FDA sets 22 April for advisory committee review of obeticholic acid in NASH, though whether the extended review was due to scheduling issues or any questions about Intercept's application itself remain unclear.

Intercept’s NASH Drug Delayed By April Advisory Committee, But Firm Is Ready For Launch

Intercept announced that the US FDA has set April 22 as date for an advisory committee review of OCA in NASH, meaning March 26 action date could be pushed back as much as three months.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS140929

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel