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The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
FSD Pharma has filed an application with the US Food and Drug Administration (FDA) seeking its approval to launch a phase 2 trial for FSD201 (ultramicronised palmitoylethanolamide, or ultramicronised PEA) in Covid-19 patients.