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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
Advertising
Report Store
UsernamePublicRestriction
Tags:
Advisory Committees Post Market Regulation & Studies Review Pathway

AMAG Open To Another Makena Trial, But Also Appears Ready To Challenge Any Withdrawal Request

  • Analysis

Executive Summary

CEO William Heiden reaffirms commitment to preterm birth drug and suggests AMAG would seek a hearing under the accelerated approval regulations if the US FDA were to request withdrawal; another placebo-controlled confirmatory trial may be possible in European and South American countries, company says.

Table

View full table

Related Content

Pink Sheet Pink Sheet Pink Sheet Pink Sheet Pink Sheet Pink Sheet Pink Sheet Pink Sheet Pink Sheet

Topics

Related Companies

Tags:
Advisory Committees Post Market Regulation & Studies Review Pathway
UsernamePublicRestriction

Register

PS141123

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

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