Cingulate Receives FDA Complete Response Letter For ADHD Treatment CTx-1301 Requesting Specific Information About Chemistry, Manufacturing, And Controls, Contains No Concerns Regarding Safety Or Efficacy

The response identified specific Chemistry, Manufacturing and Controls (CMC) information requests and did not raise any current concerns regarding the clinical safety or efficacy of CTx-1301. Cingulate expects a prompt submission to FDA of the requested information addressing issues raised.