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US (FL): Grower awaiting DEA approval for federal cannabis grower license

MMJ Biopharma Cultivation has applied for the Drug Enforcement Agency (DEA) Federal Marijuana Growers’ license. The cannabis cultivation company has negotiated an agreement with pharmaceutical company MMJ International Holdings (MMJIH) to supply pharmaceutical-grade extracts for its drug development in Huntington’s Disease and Multiple Sclerosis. MMJ Biopharma Cultivation is growing cannabis in collaboration with a Native American tribe on federal sovereign lands. The yet to be identified tribal government will be making an announcement later this week.

On Wednesday, the U.S. House of Representatives passed a groundbreaking bill to reduce barriers and expand scientific research for medical cannabis. Duane Boise the companies President stated “We support a comprehensive regulatory framework that encourages more research and development of FDA-approved, cannabis-derived medicines; it provides adequate safety protections for consumers ingesting foods and dietary supplements; and that distinguishes FDA-approved medicines from nutraceutical consumer products. This approach will ensure that patients will have access to medicines that are proven safe and effective for specific medical conditions.”

MMJ’s experienced team has worked within the DEA and FDA guidelines to obtain significant approvals. Earlier this year MMJ International Holdings received a DEA permit to import its cannabis proprietary extracts into the United States for potential therapies for Huntington’s Disease and Multiple Sclerosis. Now, MMJ researchers can proceed to develop our cannabis-derived, whole-plant, natural extract oral gel cap for FDA approval to proceed with our clinical trials in the United States,” said Dr. Elio Mariani the Company’s Executive VP in charge of drug development. Two of MMJ’s lead therapeutic candidates, MMJ-001 and MMJ-002, are liquid formulations containing highly purified THC, CBD, and other active ingredients. MMJ-001 is in development to treat spasticity (abnormal muscle stiffness) in people with multiple sclerosis. MMJ-002 is evolving to treat Huntington’s associated chorea (involuntary jerking or writhing movements). FDA granted MMJ-002 orphan drug designation in early 2019, to advance the therapy’s development.

Tim Moynahan, MMJ International Holdings’ Chairman, commented that “Because cannabis is a federally-controlled substance in the U.S., there are numerous, complicated legal hurdles that we have cleared in order to proceed with our scheduled clinical trials. This tribal agreement will facilitate our endeavors which is focused on the health and welfare of the patients suffering from these chronic diseases.”

For more information:
MMJ BioPharma Cultivation
330 3rd Street South Suite 1005 St Petersburg, Fl 33071
1-800-586-7863
1-561-627-9455
[email protected]  
mmjbiopharma.com  

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