On Clinical Hold for nearly 16 months and unable to resolve this apparent impasse with the FDA, the clinical program was stalled. On December 01, 2020, MAPS, along with legal counsel with expertise in FDA disputes, submitted a Formal Dispute Resolution Request (FDRR) to FDA. The FDRR pathway allows clinical trial sponsors to seek resolution of ongoing scientific or medical disputes with FDA that cannot be resolved with their FDA division, by escalating the matter to the overseeing department.
The FDRR brought the impasse surrounding the clinical hold of Study MT2 from the initial review division, in this case FDA’s Division of Psychiatry Products, to the overseeing Office of Neuroscience. FDA acknowledged this Formal Dispute Resolution Request and granted a meeting as is a typical part of the FDRR process to discuss the matter.