HUGE - FSD Pharma higher on FDA approval of phase 2 clinical trial of FSD201

FSD Pharma (HUGE) says FDA has authorized the initiation of a Phase 2 study 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").The company is expected to start dosing patients in October 2020. The FSD201 COVID-19 Trial is a randomized, controlled, double-blind, multicenter study, conducted on 352 patients to assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily, together with standard of care. The treatment period for patients in the FSD201 COVID-19 Trial is 14 days and the primary end point is determined at 28 days.Shares up 16% premarket.

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FSD Pharma higher on FDA approval of phase 2 clinical trial of FSD201