On this blog, we have chronicled the journeys of MMJ International Holdings (MMJ) and MMJ Biopharma Cultivation, starting with the federal government’s revisions of the Obama administration’s cannabis regulations.
During the summer of 2019, the DEA announced it would revise the existing regulations to increase access to legal marijuana for the purpose of research. At the time, the only entity that was federally approved to produce medical marijuana was the University of Mississippi. Dr. Sue Sisley with the Scottsdale Research Institute of Arizona was a key proponent in the implementation of new regulations. Dr. Sisley expressed increasing frustration at the low quality of research being disseminated from the University of Mississippi and felt that the university had a monopoly on medical cannabis research.
Most recently in their series of successes, MMJ has received approval from Health Canada to ship THC and CBD from Canada into the United States. The cannabinoids will be used in developing an FDA approved treatment for multiple sclerosis (MS) and Huntington’s Disease (HD). In addition, the US Drug Enforcement Agency’s (DEA) approval to ship the compounds for its clinical trials.
Prior to this, the FDA had awarded MMJ “Orphan Drug Designation” for its proprietary drug formulation which will be used for the treatment of Huntington’s Disease. The designation provides financial incentives to develop drugs for rare diseases that might otherwise not be developed due to the cost of development.
“We firmly believe that our MMJ natural whole plant-derived molecules with a unique combination of pharmacological properties will be FDA approved as a safe and effective prescription drug that can be of great benefit in treating patients with MS and HD diseases,” said Duane Boise, CEO of MMJ International Holdings. “We are pleased with Health Canada’s approval and the DEA’s cooperation to facilitate our company mission to service the unmet needs of patients suffering from these chronic diseases.”
Furthermore, MMJ will soon start FDA approved clinical trials on the aforementioned diseases. These clinical studies will provide valuable data to prove patient dosing, safety, and efficacy. The regulatory framework for medical marijuana has been strict, and as of recent, has only been getting even more stringent. For MMJ to progress this far is a testament to the company’s dedication to adhering to FDA and DEA regulation to provide a safe consumer health product.