Complementary to the Company’s retail business, is its ongoing Pharmaceutical Development initiative. This relates to the development of a proposed Pharmaceutical grade version of Tauri-Gum™, for nausea regulation (specifically designed for the following indication: Patients Subjected to Ongoing Chemotherapy Treatment). On March 18, 2020, the Company announced that it had filed a provisional U.S. patent application covering its pharmaceutical grade version of Tauri-Gum™. The Patent, filed with the U.S.P.T.O. is Titled “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT”. On December 18, 2020 the Company disclosed that it had entered into a Master Services Agreement with CSTI to lead the Company’s clinical development efforts.
The Company has entered into a Master Services Agreement (the “Agreement”) with North Carolina based Clinical Strategies & Tactics, Inc. (“CSTI”) to resume the clinical development of its proposed “Anti-Nausea” pharmaceutical grade version of Tauri-Gum™. CSTI will largely be focusing its efforts on the following: Pharmaceutical Development Strategy (“I.”), Commercialization Strategy (“II.”), and Funding Strategy (“III.”). The Company will be working closely with CSTI’s Founder & CEO, JoAnn C. Giannone (“Ms. Giannone”), who has over 25 years’ experience effectively leading companies through the drug and medical device development process (Prior to founding CSTI, Ms. Giannone held leadership positions with Johnson & Johnson and Pharmacia). The Company intends to fund the entirety of this Agreement, before the end of Calendar 2020.
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I. Pharmaceutical Development Strategy
- Clinical and Non-Clinical safety and efficacy strategy/studied (e.g., purpose, type, estimated sample size, treatment duration, etc.)
- Product development and manufacturing strategy (e.g., physical product formulation, scale up, testing, packaging, and analytical testing to meet stage-appropriate regulatory requirements)
- Regulatory submission strategy with defined regulatory milestones (e.g., pre-IND, IND, NDA, etc. and any special designations)
- Overall development costs and funding needs by milestone
- Overall development timeline
- Elements of the development program that should be prioritized for development
II. Commercialization Strategy
- Market Assessment
- Competitive Analysis
- Product Differentiation & Market Advantage
- Target Product Profile (“TPP”)
- Market Research
- Pricing
- Reimbursement
- Draft Forecast
III. Funding Strategy
- Non-Dilutive Options
- Commercial Partners, Venture Funds, Universities, Philanthropic Opportunities, Patient Advocacy Groups, etc.
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The delivery system for this proposed Pharmaceutical version is a modified version (substantially higher concentration of CBD) of the existing “Tauri-Gum™” chewing gum formulation based on continued research and development.
On March 18, 2020 the Company announced that it had filed a Provisional U.S. Patent covering its Pharmaceutical grade version of Tauri-Gum™. This patent application, filed with the United States Patent & Trademark Office (“U.S.P.T.O.”), is titled: “MEDICATED CBD COMPOSITIONS, METHODS OF MANUFACTURING, AND METHODS OF TREATMENT.”
U.S. Provisional Patent Application No. 62/990,709
Below – CSTI Corporate Website: