Leading FDA consultancy firm to advise on drug development and clinical trial pipeline
DENVER, Dec. 15, 2020 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced therapeutic medicine for mainstream use, announced that it has partnered with ProPharma Group, the leading provider of regulatory and compliance services to the pharmaceutical, biotech, and medical device industries. As part of the agreement, ProPharma Group will provide regulatory advisement as the company seeks approval from the Food and Drug Administration (FDA) for its drug development platform as well as the Company’s various stage clinical trials.
“ProPharma Group is a globally recognized firm with a strong track record of working with life sciences and biopharma companies to ensure full compliance with all FDA regulations, including all necessary steps for eventual global federal approvals,” said Josh Bartch, CEO and Co-Founder of Mydecine. “Mydecine currently has a jam-packed clinical trial calendar with plans to expand it to include additional various phase trials throughout the globe. Additionally, Mydecine has built a strong IP position in the psychedelics space. As we build upon our drug development platform, ProPharma Group will be a key partner for us as we explore the most efficient regulatory pathway in our mission to bring innovative treatments to the forefront for people suffering from mental health issues like PTSD and addiction.”
For more than 35 years, ProPharma Group has played an instrumental role helping its clients advance viable and efficient drug development pathways and solutions utilizing its scientific and regulatory acumen as well as its expertise in FDA, regulatory, quality and compliance, and company-related matters. With decades of experience and a positive working relationship with the FDA, ProPharma Group will serve as a key partner as Mydecine moves its drug pipeline and clinical research trials forward in an effort to increase compatibility and safety of psychedelics for therapeutic use.
“ProPharma Group has long held the leading position in working with our clients to develop strategies and supply them with viable and efficient drug development pathways and compliance solutions,” said Matthew Weinberg, Global VP for Regulatory Affairs, ProPharma Group. “Mydecine has shown a solid execution track record and is well positioned to lead in the development of the international psychedelics industry as regulations evolve. We look forward to working with the Mydecine team as they seek FDA approval for their clinical trials and drug development pipeline.”
About Mydecine Innovations Group
Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.
About ProPharma Group
ProPharma Group is the only truly global, independent, single-source provider of regulatory, compliance, pharmacovigilance, and medical information services serving pharmaceutical, biotechnology, and medical device firms. Our team of experts brings a comprehensive portfolio of regulatory and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.
Learn more at https://www.propharmagroup.com
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
Charles Lee, Investor Relations
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.