Item 8.01 Other Events

On November 25, 2019, Adamis Pharmaceuticals Corporation ("Adamis" or the "Company") issued a press release announcing that after the close of U.S. markets on November 22, 2019, it received a Complete Response Letter ("CRL") from the U.S. Food & Drug Administration ("FDA") regarding the Company's New Drug Application ("NDA") for its ZIMHI™ high-dose naloxone injection product for the treatment of opioid overdose. A CRL is issued by the FDA's Center for Drug Evaluation and Research when it has completed its review of a file and questions remain that preclude the approval of the NDA in its current form.

The CRL stated that the FDA determined that it cannot approve the Company's NDA in its present form.

The Company is reviewing the CRL and plans to request a meeting with the FDA to discuss the CRL and the Company's response to the CRL. A copy of the Company's press release is attached hereto as Exhibit 99.1 is incorporated into this item by reference.

© Edgar Online, source Glimpses