MMJ BioPharma Cultivation today has received notice from the DEA that its application for a DEA Schedule-I Bulk Manufacturer license is being processed for approval. Once awarded, the DEA approval will allow MMJ BioPharma Cultivation to cultivate cannabis plants to support MMJ International Holdings investigational new drug (IND) filings with the FDA for Multiple Sclerosis and Huntington's disease.
The MMJ BioPharma Cultivation notice stated that the “DEA intends to propose regulations in the near future that would supersede the 2016 policy statement and govern persons seeking to become registered with the DEA to grow marijuana as bulk manufacturers, consistent with applicable law,” adding that the agency recognizes “the need to move past the single grower system and register additional growers.”
Attorney General William Barr voiced support for increasing the number of marijuana manufacturers in a press release today. He stated “I am pleased that the DEA is moving forward with its review of applications for those who seek to grow marijuana legally to support research.” “The Department of Justice will continue to work with our colleagues at the Department of Health and Human Services and across the Administration to improve research opportunities wherever we can.”
MMJ BioPharma Cultivation will meet the growing demand from hospitals, researchers, and scientist for their FDA/DEA approved research and clinical trials. MMJ BioPharma Cultivation will facilitate a process of scientific drug development and discovery governed by FDA protocol development processes and DEA regulatory manufacturing guidelines.
To further meet the statutory requirements of the "public benefit" MMJ BioPharma Cultivation has entered into an agreement with a US Native Indian Tribe to perform its development activities. MMJ BioPharma Cultivation is planning a phased development program on Native American Tribal Trust lands of approximately 1 million square feet with a state of the art extraction analytics lab to meet DEA approved researchers needs. MMJ BioPharma Cultivation will be employing tribal members in its development and cultivation program.
Dr. Elio Mariani, a senior executive of the company and big pharma veteran stated "we are looking forward to our collaboration with the tribe in unlocking the potential of cannabinoid medicines to address serious medical conditions. Our efforts will be guided by the FDA and DEA as we strive to produce the highest pharma-grade plants and extracts for clinical research.”
Duane Boise, CEO of the company further stated, "At MMJ BioPharma Cultivation, we will grow quality and effective plant genetics as pharma grade medicine through the careful cultivation of cannabis plants. Our goal is to provide the purest, highest quality medicinal marijuana for the manufacture of FDA approved medicines and research.