MMJ Biopharma Cultivation is currently in the running to receive a bulk manufacturing license from the US Drug Enforcement Agency (DEA). The premier medical cannabis research company announced recently that it has begun preparations to ship THC and CBD from Canada for use in developing an oral drug product made from natural whole plant extract derivatives. MMJ will use the product for an FDA approved treatment for multiple sclerosis and Huntington’s disease. The DEA license will enable to company to cultivate pharmaceutical-grade cannabis and extract for use in clinical trials.
The DEA has set a number of stringent guidelines that applicants must meet in order to be considered for licensing, including demonstrating a case to meet the public interest, such as FDA filings for the development of a pharmaceutical.
MMJ Biopharma Cultivation meets the public interest use case because of its supply agreement with MMJ International Holdings who is in development of a cannabis-based drug to treat multiple sclerosis and Huntington’s disease; MMJ International Holdings has filed for clinical trials approval with the FDA. Right now, MMJ Biopharma cultivation is one of the few other applicants aside from universities and research institutes that have a decent shot at obtaining a federal license, according to Dr. Elio Mariani, CEO of MMJ Biopharma Cultivation. Furthermore, they plan to cultivate the crop on federally-protected Native American land.
Cultivating on Native American lands proves to be a mutually beneficial arrangement with the partnered tribe because it provides a number of economic benefits. Many members of the tribe will be employed by MMJ, and there are financial incentives for economic development on tribal lands that can be of great help to the community. As semi-sovereign nations, tribes are generally exempt from local, county, and state zoning and land-use restrictions, so the partnership also offers flexible regulatory environments.
This is a strategic move on the part of MMJ President Duane Boise, and he said, “the plan to cultivate on federally-protected Native American sovereign lands is unique and progressing rapidly to completion for final approval from the DEA.” Boise’s approach circumvents the need to be associated with a university or research institute, which so far has been the only option for cultivating federally-approved cannabis.