Christopher James's questions to ZFGN leadership • Q4 2015
Question
Christopher James from FBR & Company asked if Zafgen collected data on choking risk in its studies, given beloranib's impact on hyperphagia, and questioned the mechanics of lifting the clinical hold, such as whether it would be a partial or full removal.
Answer
Chief Medical Officer Dennis Kim responded that while choking was not a specific endpoint, no such events were captured in the safety data, and it could be a potential post-marketing study. CEO Tom Hughes added that the company will seek a complete lift of the clinical hold, but the final outcome depends on discussions with the FDA.