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

FDA Advisors To Determine Need For Post-Marketing Study Of GTC Biotherapeutics’ ATryn

This article was originally published in The Pink Sheet Daily

Executive Summary

The antithrombin’s efficacy and safety profile suggest ATryn has a clear path to approval.

You may also be interested in...



For Rare Disorders, Best Shot At Showing Clinical Benefit Is Post-Market –FDA

FDA is acknowledging that clinical benefit for patients with rare conditions may best be verified through post-marketing trials, given the difficulty of conducting clinical trials in those populations

For Rare Disorders, Best Shot At Showing Clinical Benefit Is Post-Market –FDA

FDA is acknowledging that clinical benefit for patients with rare conditions may best be verified through post-marketing trials, given the difficulty of conducting clinical trials in those populations

GTC Nails ATryn Deal With Ovation

Small payout now, but more may be due later, as the antithrombin goes up against sepsis and heparin resistance.

Topics

UsernamePublicRestriction

Register

LL1134043

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