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US (FL): Approval process going forward to grow MMJ on tribal lands

MMJ Bio Pharma Cultivation has received notification that the DEA approval process is moving forward processing the company application to grow cannabis as a bulk manufacturer for cannabis research. "A notice was published today in the Federal Register," the team with the company explains. "MMJ is developing an oral drug product from natural whole plant extract derivatives from the cannabis plant containing THC and CBD. MMJ will be utilizing its new product for an FDA approved treatment for multiple sclerosis (MS) and Huntington's disease (HD)."

In August 2019, the Drug Enforcement Administration (DEA) announced its plans to revise former President Obama's federal cannabis regulations, and today in doing so with the Federal Register notice, it will begin processing applications for access to cannabis research. In order to obtain a federal license, applicants must adhere to very strict guidelines, including demonstrating a case for the public interest. One way to do this is to submit an Investigational New Drug filing to the FDA for the development of a pharmaceutical, and of the 35 applicants so far, only a few have filed for clinical trials to prove safety, dosing, and efficacy to the FDA.

Universities and Research institutes are the most likely candidates to obtain a federal growing license, yet MMJ Biopharma Cultivation has met the strict guidelines set forth by the DEA for the product development and distribution to DEA-registered researchers. Duane Boise stated, "We meet the public interest requirement evidenced by our filings with the FDA, in our development of a cannabis-based drug to treat Multiple Sclerosis and Huntington's Disease. We have applied and now awaiting approval for the DEA bulk manufacturing license to continue our development of an FDA-approved pharmaceutical."

Aside from meeting the public interest requirement, Boise has another strategy: he plans to cultivate the crop on federally-protected Native American sovereign lands. "The arrangement is mutually beneficial, as MMJ Biopharma Cultivation will end up employing many members of the American Native Tribe on which the pharmaceutical grade cannabis will be cultivated on its 38 acres."

The only approach so far, that would be a viable opportunity to cultivate federally-approved cannabis, would be the association with a university, but Dr. Elio Mariani, CEO of MMJ Bio Pharma Cultivation has managed to circumvent this with his nascent approach."As MMJ BioPharma Cultivation will support MMJ International Holdings which continues to advance to its clinical trials, a specialty pharmaceutical solutions company will be supporting MMJ with the FDA, DEA required development API and specialized liquid encapsulation solutions," said Dr. Elio Mariani,"Patients will benefit from cGMP-quality therapies in an accessible and efficient format."

Most recently the FDA awarded MMJ International Holdings ″Orphan Drug Designation″ for its THC and CBD proprietary drug formulation which will be used for the treatment of Huntington's Disease. The drugs, MMJ-001 and MMJ-002 are two of MMJ's lead drugs that the company is confident will bring much needed relief to patients suffering from the debilitating effects of Multiple Sclerosis and Huntington's Disease.

The DEA amendments to the 2016 Obama policy statement supersede the current policy in place and govern applicants seeking to become registered. One of the key revisions of the policy includes moving away from a single grower system and registering additional growers. The Department of Justice has also been involved in the process to "ensure that the cannabis growers' program is consistent with applicable laws and treaties." The DEA first announced its intent to license private entities to grow Cannabis for FDA approved clinical trials in 2016. However, there was lingering progression by the DEA to approve access for medical grade cannabis delaying many researchers and private entities wanting to further their research for pharmaceutical grade medicines. The hold up is subsiding after a long waiting period from the DEA, and allows for MMJ Bio Pharma Cultivation to move forward with its goal to produce superior and pure medical cannabis for patients facing pain and chronic illnesses.

Along with licensing approval to grow cannabis as bulk manufactures for cannabis research with the approval of DEA, MMJ International's Holding's hit another millstone last month as it received Health Canada and the DEA approval to ship pharmaceutical grade THC and CBD for it's drug development. The company continues its process of scientific drug development and discovery by FDA protocol development processes, intellectual property portfolio, and DEA regulatory manufacturing guidelines to protect the public health interest.

For more information:
MMJ BioPharma Cultivation
330 3rd Street South Suite 1005 St Petersburg, Fl 33071

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