US FDA insists on 2nd Phase III trial for BiovaxID; Biovest tumbles
This article was originally published in Scrip
Executive Summary
Even Biovest's pleadings to the US FDA about the unmet need for patients with follicular non-Hodgkin's lymphoma could not convince the agency that a second Phase III trial would not be needed for the company's biologics license application to approve BiovaxID, a personalized cancer vaccine.