ACCESSWIRE
01 Aug 2022, 22:01 GMT+10
Both bills eliminate researchers from obtaining any marijuana products from any state dispensaries or growers.
WESTERLY, RI / ACCESSWIRE / August 1, 2022 / MMJ International Holdings, MMJ BioPharma Labs, and MMJ BioPharma Cultivation the premier medical cannabis research companies announced that it has completed the FDA required manufacturing of its proprietary THC and CBD marijuana soft gelatin capsule. MMJ International Holdings has several filings with the FDA in Multiple Sclerosis and Huntington's disease and is developing a non-synthetic oral drug product from the marijuana plant extracts. MMJ will be utilizing its new product for its clinical trials once FDA approved.
MMJ had received a DEA permit to import its cannabis proprietary extracts into the United States to develop therapies for Huntington's Disease and Multiple Sclerosis. After a considerable amount of work, the team has reach several milestones by developing its proprietary scientific extraction process of THC, CBD, and other ingredients for its drug formulation. MMJ was awarded the coveted FDA Orphan award for Huntington's disease and MMJ BioPharma Labs has been awarded their DEA cannabis schedule 1 analytical lab registration.
While MMJ has been cooperating with multiple government agencies, including FDA, DEA, U.S. Customs and Border Protection (CBP), Health Canada, and the Center for Drug Evaluation and Research (CDER), to accomplish its mission most recently it was forced to file suit against the DEA for dragging their feet. Duane Boise the President and Founder stated ' Unfortunately we had to file suit against the DEA to facilitate a response however we are in discussion to clarify any concerns the DEA may have. We feel confident that the API Bulk Manufacturing registration will be issued soon. The DEA is currently processing the company's application so it can proceed with the FDA required evaluation and research'.
Tim Moynahan, the companies chairman opined ' it is egregiously wrong that the DEA has taken so long to process our application. We have been patient since December of 2018 waiting for the DEA to act. We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work with the FDA and DEA to fill in the knowledge gaps about the science safety and quality of MMJ's products. We are committed to advancing our product development through an approach that is in line with the governments mission to prioritizes public health, fosters innovation, and promotes consumer confidence.
The DEA has stated, ' the DEA anticipates that additional strains of marihuana will be produced and made available to researchers. This should facilitate research, advance scientific understanding about the effects of marihuana, and potentially aid in the development of safe and effective drug products that may be approved for marketing by the Food and Drug Administration,'
Dr Elio Mariani, the CEO stated, 'MMJ's clinical trials will provide patient dosing, safety, and efficacy data to the FDA to prove that cannabis can treat the debilitating effects of Multiple Sclerosis and Huntington's Disease. MMJ continues its process of scientific drug development and discovery by following the FDA development processes and the DEA regulatory manufacturing guidelines.
This past week the U.S. House of Representatives passed a revised bipartisan bill that would make it easier for researchers to study marijuana. The bill passed Tuesday by a resounding vote of 325-95. The Medical Marijuana and Cannabidiol Research Act, or H.R. 8454, now goes to the Senate, where it is expected to pass.
Both bills eliminate researchers from obtaining any marijuana products from any state dispensaries or growers.
Researchers can only obtain product for research from DEA approved schedule 1 registrants.
CONTACT:
Sara Parker
media@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
Get a daily dose of Maryland Leader news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Maryland Leader.
More InformationZAGREB, Croatia: Authorities have said that a weekend bus crash near Varazdin in Croatia killed 12 passengers and injured 32.The ...
WASHINGTON D.C.: The U.S. will participate in a joint military exercise in mid-October with India, less than 62 miles from ...
SEOUL, South Korea: South Korea has launched a domestically manufactured lunar orbiter that took off from Florida's Cape Canaveral Space ...
MOSCOW, Russia: A leading Russian scientist in the field of hypersonic flight, Dr. Alexander Shiplyuk, has been arrested on suspicion ...
LOS ANGELES, California: During a meeting that was disrupted by protesters this week, the Los Angeles City Council voted to ...
WASHINGTON D.C.: The U.S. Justice Department announced this week that former Puerto Rico governor Wanda Vazquez has been arrested in ...
NEW YORK CITY, New York: After a study released on Wednesday projected a 15 to 20 percent reduction in the ...
MOSCOW, Russia: Financial information released by the Rosstat federal statistics service this week indicated that Russia's economy shrank 4 percent ...
KATHMANDU, Nepal - While the Ministry of Finance has begun repaying interest on the loans for the planes, a batch ...
WASHINGTON D.C.: Providing relief to drivers in the United States, the average retail gasoline price in the US fell below ...
NEW YORK CITY, New York: Walmart could sign a deal with Disney, Paramount, or Comcast, with the aim of breaking ...
MILAN, Italy: Milano Today has reported that seven years after launching in the country, American pizza giant Domino's has now ...