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Monday, August 31, 2020

FSD Pharma files IND for FSD201 to treat COVID-19 patients

FSD Pharma (NASDAQ:HUGE) has submitted to the FDA an Investigational New Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19 (the “FSD201 COVID-19 Trial”).

The trial will assess the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice-daily together with standard of care (SOC) compared to SOC alone in hospitalized patients with documented COVID-19 disease.

Additionally, the Board of Directors has authorized the issuance of an additional 369,255 class B subordinate voting shares to certain of the company’s directors, officers, employees and consultants.

Dr. Raza Bokhari acquired 805,802 Class B Shares in lieu of compensation for his services as CEO and Executive Co-Chairman. As a result, he now owns ~8.5% of the Class B shares, in addition to 33.3% of the outstanding Class A multiple voting shares. In aggregate, he controls ~23% of the voting rights attached to the issued and outstanding FSD shares.



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