PROVIDENCE, RI / ACCESSWIRE / September 6, 2022 / Duane Boise, MMJ companies President echoing the NIH directors recent statements remarked, "Unfortunately MMJ was forced to file suit against the DEA for its incomprehensible actions. Having issued a schedule 1 analytical lab license in January, MMJ is still waiting for the DEA to issue its grow registration. Fortunately, MMJ has overcome the majority of federal obstacles and is nearing completion of its state-of-the-art, marijuana center of excellence," stated the firm in a recent press release.
WHY HAS THE DEA FAILED ITS MARIJUANA MANDATE?
From The NIH Director - Helene M. Langevin, M.D.
"Breaking Down the Barriers to Cannabinoids Research"
MMJ Companies, the premier medical cannabis development and research, group announced that it has completed the FDA required manufacturing of its proprietary THC and CBD soft gel capsule medicine. MMJ has developed a dose form, non-synthetic oral drug product from the marijuana plant extracts. MMJ will be utilizing its new product for an FDA-approved treatment of multiple sclerosis (MS), and Huntington's disease (HD) for its clinical trials once approved.
Tim Moynahan lawyer and companies chairman stated "As the MMJ companies continue to overcome their struggle with the DEA's unexplained and unanswered delay, the issue is why has the DEA failed its legislative mandate? The DEA's incomprehensible actions are denying suffering patients from potential relief from the benefits that cannabis will offer."
Is the DEA above the law?
As stated on the DEA website, "A Diversion Investigators mission is to enforce the Controlled Substances Act and the Chemical Diversion and Trafficking Act regarding the manufacture, distribution and dispensing of legally produced controlled substances and listed chemicals in order to prevent diversion of controlled substances and listed chemicals into the illicit market, while ensuring an adequate uninterrupted supply of pharmaceutical controlled substances and listed chemicals to meet the legitimate medical, commercial and scientific needs of the public. However, MMJ has been delayed since December 2018.
Breaking Down the Barriers to Cannabinoids Research-From the National Institutes Director
Helene M. Langevin, M.D. is quoted,"Research on cannabinoids is fraught with hurdles. For example, some researchers may not know how to navigate the process of securing a Schedule 1 license. Others might be hindered by the lack of broadly accepted measures for what constitutes a "dose" or modes of administration. Thus, a key step in successfully generating more scientific evidence around the potential clinical uses of cannabis products is to identify barriers to conducting research and subsequently develop approaches that can help overcome them".
"As MMJ International Holdings continues to advance to its clinical trials, these DEA delays are unprecedented and we will get to the bottom of this," stated Elio Mariani, Ph.D., of MMJ.
Following the federal directives MMJ has meet several critical milestones:
- FDA "Orphan Designation" for its clinical trial in Huntington's Disease.
- The company has an investigational new drug (IND) application filed with the FDA to begin clinical trials in MS
- DEA Approved international import of THC formulation from strain specific marijuana
- Issuance of State Pharmaceutical Licenses
- Issuance of Local use permits
- FDA registrations to conduct manufacturing activities
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,"
Recently 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, and 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 as it is in violation of the Controlled Substance Act.
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/714667/Patients-Suffer-as-Dea-Unexplained-Delays-MMJs-Marijuana-Research-Clinical-Trials-and-Pharmaceutical-Development
