Phase 2 Clinical Trial IND Filing With The FDA it has submitted to the U.S. Food and Drug Administration (“FDA”) an Investigational New Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus (the “FSD201 COVID-19 Trial”). Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm and ultimately death. As previously announced, FSD Pharma is focused on developing FSD201 for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.