Pre-IND Application Request Has Been Submitted to FDA OXFORD, Ohio and COCONUT CREEK, Fla., Sept. 23, 2021 /CNW/ - PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the "Company"), an intellectual property driven biotechnology company developing novel, bespoke, fully approved, psycho-targeted therapeutics to potentially improve mental and neurological health, today reported it has submitted its first pre-Investigational New Drug ("IND") application meeting request to the United States Food and Drug Administration ("FDA") as part of the regulatory submission process.
The FDA's Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant IND submission.[1] PsyBio is dedicated to working towards obtaining all necessary regulatory approvals for its therapeutics under development and intends to submit its most promising potential therapeutic candidates to the appropriate regulatory body as part of the approval process. The submission of this pre-IND meeting request for collaborative discussions with the FDA has been submitted in anticipation of filing the first of several clinical IND packages.
"This is a significant milestone for PsyBio as there are currently no approved indications for psilocybin or other similar compounds," stated Michael Spigarelli, MD, PhD, MBA, PsyBio's Chief Medical. "We look forward to working with the FDA to define what would be considered sufficient proof of safety and efficacy within the target populations. This is the first step to defining an acceptable medical use for these compounds, a critically necessary component in order to facilitate further developing and manufacturing at the necessary scale for this new class of potential therapeutics."
"This submission firmly establishes PsyBio among the top biotechnology companies actually seeking regulatory approval for their psychoactive therapeutic candidates," stated Evan Levine, Chief Executive Officer, PsyBio. "The Company's logical and validated testing approach allows PsyBio to effectively design and develop therapeutics to potentially treat specific clinical conditions and submit those to the appropriate regulatory agencies for approval and marketing authorization. PsyBio is doing this as part of our commitment to research and develop potential therapeutics for mental and neurological health."
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