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Wellbeing Subsidiary KGK Science Announces AKL No Objection Status for ProGo® Branded Ingredient from FDA
KGK client, Hofseth Biocare ASA, is yet again part of an Exclusive Short-List of Companies to Have Successfully Notified FDA while receiving a No Objection Acknowledgement (AKL) Letter for ProGo® Bioactive Peptides
Wellbeing Digital Sciences Inc. (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based mental healthcare company focused on the development and implementation of innovative clinical solutions, including psychedelic medicine and digital therapeutics as supported by clinical research, announces that its wholly owned subsidiary KGK Sciences Inc. (“KGK”) provided regulatory guidance and expertise on behalf of its client, Hofseth Biocare ASA (HBC.OL) (“HBC” or the “Client”), to develop a New Dietary Ingredient (“NDI”) dossier for notification to the US Food and Drug Administration (the “FDA”) for its patented ProGo® branded ingredient. FDA has responded with a no objection letter, also called an Acknowledgement (AKL) Without Comment Letter.
HBC, a leading manufacturer and marketer of unique and innovative marine-derived calcium, protein, collagen, and lipid nutritional supplements, is now part of an exclusive short list of companies that have successfully notified FDA of their NDI. The AKL response letter from FDA for ProGo® is the highest safety rating and attestation the Client could have received for its dietary ingredient. This achievement follows on the heels of successful receipt of the same accolades for both CalGo® and OmeGo® late last year. Today, HBC’s entire portfolio of human food-grade ingredients has received FDA’s “good day” AKL Letter.
“KGK has significant experience in helping its clients achieve their goals by earning these high marks of achievement and market distinction and we are thrilled to be able to assist HBC, a valued client of KGK, distinguish themselves from its competitors,” said Najla Guthrie, CEO of Wellbeing and KGK. “Consumers and retailers are starting to understand what it means to have an AKL no-objection letter from the FDA. Both can have confidence that the serving levels in these products are correctly chosen, based upon appropriate scientific methods, and rigorously reviewed by FDA scientists,” added Najla.
“KGK is a leading contract research organization (CRO), offering high-quality clinical research trials and expert regulatory support for the nutraceutical industry,” said Angelika Florvaag, Chief Quality Officer at HBC. “At HBC we pride ourselves in producing superior health ingredients to enhance human health and quality of life, above and beyond what is currently available in the market today and KGK has enabled us to continuously meet that high standard,” commented Angelika.
ABOUT KGK SCIENCE
Subsidiary of Wellbeing Digital Sciences, KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 25,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
ABOUT WELLBEING DIGITAL SCIENCES
Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the development and implementation of innovative clinical treatment solutions, including psychedelic medicine and digital therapeutics, as supported by clinical research. Its mission is supported by a network of North American clinics that provide forward-thinking therapies and other types of treatment to patients as well as through a contract research organization that offers clinical trials services to clients pursuing drug development. For additional information, please visit wellbeingdigital.co.
ABOUT HOFSETH BIOCARE
Hofseth BioCare (HBC) is a fully integrated salmon business, devoted to enhancing human nutrition and wellbeing in the most natural, sustainable way. Its naturally safe ingredients deliver pure nutritional performance and clinically-proven health benefits, while conserving the delicate ecological balance. A global leader in marine lipid and peptide research, HBC’s resourceful, tried and trusted, truly sustainable approach to human health is unrivalled. Patent-protected enzymatic hydrolysis technology preserves high-quality lipids, proteins and calcium/collagen, yielding naturally safe ingredients with clinically proven health benefits. For additional information, please visit https://hofsethbiocare.com.
On behalf of:
Najla Guthrie
Chief Executive Officer
WELLBEING DIGITAL SCIENCES
Notice Regarding Forward-Looking Information:
This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.
The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220825005205/en/
Contacts
Natalie Dolphin
VP of Marketing & Investment Relations
Email: ndolphin@wellbeingdigital.co
Twitter: @Wellbeing_IR
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