Adamis Pharma plunges on FDA rejection of Zimhi application for opioid overdose

• Adamis Pharmaceuticals (NASDAQ:ADMP) slumps 43% premarket in reaction to the announcement that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for its ZIMHI high dose naloxone injection product for the treatment of opioid overdose.
• The CRL stated that the FDA cannot approve the NDA in its present form and provided recommendations needed for resubmission.
• The questions raised were generally related to new Chemistry, Manufacturing and Controls issues. No issues related to “extractables and leechables testing”, that were associated with the previous CRL were noted.
• The company plans to provide the Agency with additional analysis and information in order to satisfy the CRL items and will request a Type A meeting or consider other options to resolve the issues.
• https://seekingalpha.com/news/3636453-adamis-pharma-plunges-43-on-fda-rejection-of-zimhi-application-for-opioid-overdose