$ADMP I KNOW I will catch hell for saying this, but here goes. A couple of facts: the CDC , DOD, DHS, DHHS, plus a dozen more sub agencies are tasked with fighting the opioid crisis by every means available. The FDA has told Admp, " no safety or efficacy issues" with Zimhi. CMC is related to quality and manufacturing. IMO, the FDA wants to make absolutely certain that manufacturing and product quality are up to the task of joining the nationwide battle for American lives. Jmho.