TORONTO– FSD Pharma Inc. (Nasdaq: HUGE) (CSE: HUGE.CN) (“FSD Pharma” or the “Company”) today announced that it has submitted to the U.S. Food and Drug Administration (“FDA”) an Investigational New Animal Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat Gastrointestinal enteropathy in dogs. The application has been accepted for review.
The proposed trial design is a randomized, double-blind, placebo-controlled, crossover, trial comparing FSD201 (ultramicronized Palmitoylethanolamide (PEA)) dosed twice daily for 30 days to placebo for the treatment of canine inflammatory bowel disease. The primary endpoint will be a validated diarrhea score, evaluated by both treating veterinarian and dog owner. The trial will be conducted at 5-10 sites in the USA, and will enroll up to 200 dogs.
Vote Only the BLUE Proxy FOR the Management Director Nominees
FSD Pharma thanks shareholders for the strong support the Company has received ahead of its upcoming Annual and Special Meeting of Shareholders (the “Meeting”).
On May 5, FSD Pharma announced that Institutional Shareholder Services Inc. (“ISS”), a leading independent international corporate governance analysis and proxy advisory firm, had recommended that shareholders vote FOR all Management Director Nominees i and FOR the elimination of the dual-class share structure (the “Dual-Class Sunset”) at the Meeting.
FSD Pharma urges shareholders to go to FSD Pharma’s website www.fsdfuture.com to cast their vote electronically and for additional information on how the Company has the right strategy and the right Management Director Nominees to build on its positive momentum towards value creation for all shareholders. Shareholders should contrast this plan with that of the Dissidents, whose self-serving approach pulls the Company backwards, making promises that are unlikely to materialize into real shareholder value creation.
