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

Sarepta's Duchenne Treatment Likely Making Progress At FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Data in advisory committee briefing addendum judged major amendment, requiring more review time.

You may also be interested in...



US FDA Freezes Inspections And Outside Meetings. Will Review Goal Dates Stay Put?

Sponsors have been asked to switch to teleconferences with FDA staff as the agency prepares for more of its employees to work from home.

As Coronavirus Tightens Its Grip, US FDA Cancels Some Meetings Due To ‘Extenuating Circumstances’

Agency won't say whether patient-focused drug development meeting and gene therapy conference were postponed because of COVID-19, but other meetings remain as scheduled.

Sarepta Complained To Woodcock About Exondys 51 Review Early And Often

Documents also show that Sarepta officials begged CDER director for approval on multiple occasions prior to the agency's September 2016 decision.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1125791

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