Sentynl Therapeutics, Inc.: copper histidinate

° listed in this application, FDA conveyed deficiencies to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.

The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require re-inspection of the facility.

Satisfactory outcomes of both the PAI and the CGMP surveillance inspections will be needed prior to an approval of the application.