Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Better Late Than Never: “Breakthrough” Status Aided Sovaldi’s On-Time Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Although Gilead’s hepatitis C drug picked up the “breakthrough therapy” moniker with just two months left in the NDA review cycle, the designation enabled FDA staff to analyze new VALENCE and PHOTON-1 trial data and still approve sofosbuvir by the PDUFA goal date.


Related Content

How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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