FDA finds 'multiple problems' with Ampligen data; Hemispherx gets whacked
This article was originally published in Scrip
Executive Summary
Shares of Hemispherx Biopharma plummeted 51% on 18 December after US FDA drug reviewers said there were “multiple problems” with the company's data submitted in its new drug application (NDA) for Ampligen (rintatolimod), an investigational treatment intended for use in patients with chronic fatigue syndrome (CFS), a complex, debilitating disorder of unknown etiology.