Pompano Beach, FL, Sept. 17, 2018 (GLOBE NEWSWIRE) - Nesvik Pharmaceuticals, Inc., a wholly owned subsidiary of BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem” or the “Company”), focused on the development of novel reformulated pharmaceutical products that address unmet needs in large, established and underserved markets, announced today that the Company will engage The Gnomon Group (“TGG”) to provide senior regulatory strategy support, document formatting, eSubmission publishing, and submission management support for their investigational products.
This proposal covers assisting Nesvik with pre-Investigational New Drug Application (“pre-IND”) communications with the FDA for all current investigational products. Activities will include establishing electronic submission (ESG) authorization, preparation and eSubmission of pre-IND documents and participation in FDA meetings/interactions.
About Nesvik Pharmaceuticals, Inc. A company focused on the development of novel reformulated pharmaceutical products that address unmet needs in large, established and underserved markets.
About The Gnomon Group Mike Dalton and Tom Schumaker founded The Gnomon Group in 2007. Mike and Tom have over 50 years combined work experience in a variety of large and small pharma companies and CROs. Seeing the challenges faced by startup, small, and mid-sized pharma companies in accessing the pharmaceutical development experience needed to move promising ideas forward, they formed The Gnomon Group to provide virtual project teams to these companies.
About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine. The Company’s mission is to discover, develop and produce the most effective Pharmaceutical and Regenerative Medicine products in the world. The Company is comprised of a diverse group of scientists, physicians, and entrepreneurs who collaborate to create innovative products. These technologies improve the Quality of Life for our patients and, as a result, drive shareholder value.
Forward-Looking Statements: Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the company with OTC Markets.
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Andrew Van Vurst