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

Patients Can't Rescue Sarepta's Eteplirsen

This article was originally published in The Pink Sheet Daily

Executive Summary

Hours of testimony was clearly compelling, but advisory committee agreed with FDA concerns about the Duchenne muscular dystrophy drug's efficacy.

Advertisement

Related Content

Translarna AdCom Has DMD Experience, But Most Opposed Approval Of Prior Applications
Once More Unto The Breach: PTC's Duchenne Drug Translarna Gets Advisory Cmte.
Sarepta Winning Payer War Over Duchenne Muscular Dystrophy Drug Coverage
Sarepta Eyes Patient Outcomes To Boost Exondys 51's European Review
FDA's Savings Machine: The White Oak Conference Room
FDA's Fears Realized: Sponsors Pitching Investors 'Sarepta Model'
Political Appointees Shouldn't Influence Approval Decisions, Califf Says
Woodcock's Consideration of Sarepta Financial Issues Raises Eyebrows
Sarepta's Eteplirsen Is Centerpiece Of Senate Hearing On Expanded Access
BioMarin's Drisapersen 'Compete Response' Shows FDA Flexibility Still Limited

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS079345

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