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

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

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.

Advertisement

Related Content

Eteplirsen Approval Reflected FDA's Conflict On Accelerated Approval – Former Sarepta CEO
Political Appointees Shouldn't Influence Approval Decisions, Califf Says
No More Sarepta-Like Development, FDA Officials Say
The Eteplirsen Approval: Former FDA Officials Weigh In On The Science
Patient Advocacy With FDA Review Staff Will Be Tougher Post-Sarepta
Eteplirsen Review Offers Lessons For FDA, Advocacy Groups, Industry
Duchenne Development: Six-Minute Walk Losing Favor?
Eteplirsen Review Timeline: CDER Director Was Involved Early And Often
Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate
Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows

Topics

Related Companies

Related Deals

Advertisement
UsernamePublicRestriction

Register

PS119720

Ask The Analyst

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

All set! This Question has been sent to 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