Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Eteplirsen Approval Reflected FDA's Conflict On Accelerated Approval – Former Sarepta CEO

Executive Summary

There is anxiety within the US agency over use of the pathway amid the prospect for confirmatory trials to fail, former CEO Garabedian says at FDA/CMS Summit.

You may also be interested in...



Drug Review Profiles: Behind The Scenes At US FDA

A year in our long-running series of deep dives into FDA review documents.

Exondys Approval: Measured Efficacy Outcomes Vs. Patient 'Anecdotes'

Pink Sheet’s Drug Review Profile looks at US FDA clinical memos opposing approval of Sarepta's Duchenne muscular dystrophy drug eteplirsen, revealing challenges patient advocates and agency face in transforming patient experiences into hard data that can be used for approvals.

Exondys Approval: Measured Efficacy Outcomes Vs. Patient 'Anecdotes'

Pink Sheet’s Drug Review Profile looks at US FDA clinical memos opposing approval of Sarepta's Duchenne muscular dystrophy drug eteplirsen, revealing challenges patient advocates and agency face in transforming patient experiences into hard data that can be used for approvals.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS119680

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

Cancel