Scrip 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

FDA change of mind – to add new arm to trial - sets EpiCept's Ceplene further back

This article was originally published in Scrip

Executive Summary

EpiCept has received another blow to its bid to gain approval for its lead drug candidate, Ceplene (histamine dihydrochloride), after the US FDA's initial response to its Special Protocol Assessment (SPA) application was in contrast to what was agreed during earlier discussions, according to the company.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC013474

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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