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
View source version on accesswire.com:
https://www.accesswire.com/710334/Senate-To-Pass-Marijuana-Research-Act–MMJ-BioPharma-Cultivation-DEA-Approval-Imminent
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