Question · Q4 2015
Brett Larson of Leerink Partners inquired about the specific path forward for beloranib following the submission of the risk mitigation data package to the FDA, including potential timelines for lifting the clinical hold and whether updates on other pipeline programs would be paused.
Answer
CEO Tom Hughes explained that Zafgen has an agreement with the FDA on the content for the briefing book and expects the process of meeting and receiving feedback to take a "series of months." He clarified there is no special quiet period, just standard FDA procedure timing. Hughes also stated that updates on other programs would be provided once there is clarity from the FDA, which could occur before the hold is formally lifted.