Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Will Palatin's Phase III Female Sex Endpoint Swap Pass With FDA?

Executive Summary

Palatin plans to file the drug for FDA approval in the second half of 2017, but a change in the co-primary endpoint presents a complication.

You may also be interested in...



AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input

US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.

Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track: A Week Of Calm As Shutdown Drags On

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS119444

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