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
Benzinga Newsdesk 5 months ago
NewsFDA
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
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.