New Colombia Resources Forming Joint Venture to Apply for an Orphan Drug Designation with the Food and Drug Administration (FDA) for a Medical Cannabis Pharmaceutical Product
BARRANQUILLA, Colombia, October 14, 2016 /PRNewswire/ --
New Colombia Resources, Inc.(OTC: NEWC) (the "Company"), a U.S. listed Colombian resource company with premium metallurgical coal and medical marijuana assets, is pleased to announce they will be applying for an orphan drug designation with their collaboration partners, Advanced Imaging Projects, LLC (AiP) for regulatory agency approvals of a cannabinoid pharmaceutical product for multiple medical indications with a focus on treatment of a rare pediatric disease. Once the application is submitted the designation and/or comments are expected within 90 days. The Company expects to file the application in the next 60 days.
Other companies with cannabis drug applications with the FDA include, GW Pharmaceutical (NASDAQ: GWPH), Zynerba Pharmaceuticals (NASDAQ: ZYNE), and INSYS Therapeutics (NASDAQ: INSY). These designations confer significant advantages including waiver of application filing fees, expedited approval, government grants, and reduced number of patients in clinical trials. Dr. Stanley Satz , Chairman and Chief Scientific Officer of Advanced Imaging Projects stated, "My sense is that by working together with New Colombia Resources, similarly we could obtain this for the cannabinoid under development."
New Colombia Resources and Advanced Imaging Partners have been in discussions and meetings in the U.S. and Colombia for the past year and are building a team of physicians, biostatisticians, and toxicologists in preparedness of FDA trials and a pre- IND meeting. With many more states expected to approve medical marijuana in the upcoming elections, including Florida, they feel it is the best time to submit the application which they've been working on for the past year.
The joint venture will seek the collaboration of Colombia's Ministry of Health for the clinical trial to be conducted in Colombia. The Ministry has publicly expressed interest in bringing Cannabis research to Colombia and the Company feels their project is in line with this aspiration. In late August, New Colombia Resources received a letter from the Presidency of Colombia directed to the Health Minister requesting his assistance on behalf of the company's medical marijuana project. "There would be great personal satisfaction in this project as I lived in Colombia for 5 years while working for the World Health Organization there," further commented Dr. Satz.
To view or purchase cannabis based products from the Company's medical marijuana joint venture in Colombia, Sannabis, visit http://www.sannabis.co. Follow Sannabis on Facebook for photos and testimonials at https://www.facebook.com/sannabis.cannamedicinal
New Colombia Resources, Inc.
New Colombia Resources, Inc. is focused on the acquisition and development of high-quality metallurgical coal properties and other available resources in the Republic of Colombia. They expect to have several revenue producing businesses including; metallurgical coal mining and rock quarry aggregates for domestic Colombian highway and railroad building projects. The Company owns 100% of La Tabaquera metallurgical coal mine in Colombia with an estimated 15- 17 million tonnes of reserves. They have another pending acquisition for 390 ha and a solicitation contract for 184 ha metallurgical coal concession. New Colombia Resources also holds a significant position in Sannabis SAS which legally produces medical marijuana products in the Republic of Colombia, visit http://www.sannabis.co. For more information on the Company visit http://www.newcolombiaresources.com.
Forward Looking Statements
Forward Looking Statements; This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing works such as "anticipate," "seek," intend," "believe," "plan," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements might not occur. Factors that could cause or contribute to such differences include financing, the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations. New Colombia Resources, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.
Contact Information Media/Company Contact: New Colombia Resources, Inc. John Campo President/Chairman +(1)-410-236-8200 USA +(57)-318-657-0918 Colombia firstname.lastname@example.org
SOURCE New Colombia Resources Inc.