Vancouver, British Columbia, April 12, 2022 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced it has held a pre-investigational new drug application (PIND) meeting with the United States Food and Drug Administration (FDA) Division of Psychiatry (The Division). During the course of the meeting, Filament and The Division discussed Filament’s natural psychedelic drug candidates, drug development strategy, and long term plans. Filament has received official minutes of the meeting from FDA.
“We thank The Division for their time and their valuable insights,” said Jeff Fellows, Head of Regulatory Affairs at Filament Health. “The opportunity for biotech companies like Filament to meet with the FDA to discuss pertinent issues in real time is highly beneficial.”
The meeting was well attended by FDA including senior staff and numerous medical, product, and nonclinical reviewers. Filament Health was represented by Benjamin Lightburn, CEO and Co-Founder, Jeff Fellows, Ryan Moss, Chief Science Officer, Joshua Woolley, MD/Ph.D, Clinical Advisor and Director of the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco.
“We are pleased that the FDA is receptive to our drug development plans,” said Mr. Lightburn. “Our conversation was open and productive, and we look forward to many more between Filament and The Division in future.
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.
Anna Cordon, Director of Communications
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FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including results of the clinical trial. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.April 7