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.