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
FAQs
Advertising
Report Store
UsernamePublicRestriction
Tags:
BioPharmaceutical

Encysive To Enter Dispute Resolution With FDA Over Third Thelin “Approvable” Letter

This article was originally published in The Pink Sheet Daily

  • News

Executive Summary

Company asserts that FDA’s data analysis of STRIDE-2 trial for Thelin does not follow special protocol assessment agreement.

You may also be interested in...



Encysive Dispute Resolution Request For Thelin Negged By FDA

Securing approval by conducting an additional Phase III study as requested by FDA would take years, CEO Cole tells “The Pink Sheet” DAILY.

Encysive Dispute Resolution Request For Thelin Negged By FDA

Securing approval by conducting an additional Phase III study as requested by FDA would take years, CEO Cole tells “The Pink Sheet” DAILY.

Encysive To Cut U.S. Work Force By 70 Percent To Curb Cash Flow

Company also appoints George Cole to CEO, replacing Bruce Given, following on the heels of an FDA “approvable” letter for Thelin.

Table

View full table

Related Content

Pink Sheet
Pink Sheet

Topics

Tags:
BioPharmaceutical
UsernamePublicRestriction

Register

LL1135415

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

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