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Biden's DEA Marijuana Scam: MMJ BioPharma Awaits Marijuana Registration to Grow Pharmaceutical Cannabis

Tuesday, 11 June 2024 12:40 AM

MMJ BioPharma Cultivation

NO FEDERAL MARIJUANA IS BEING GROWN

MMJ Marijuana Researcher Calls Biden's DEA a Rogue Law Enforcement Agency

WASHINGTON, DC / ACCESSWIRE / June 11, 2024 / MMJ BioPharma Cultivation, MMJ Biopharma Labs, and MMJ International Holdings are at the forefront of pharmaceutical cannabis research, with FDA Investigational New Drug (IND) filings to conduct clinical trials for Multiple Sclerosis (MS) and Huntington's Disease (HD). MMJ International Holdings has successfully manufactured proprietary THC and CBD non-synthetic soft gelatin capsules derived from marijuana plant extracts. These formulations have been submitted to the FDA for approval, making MMJ the only company with a final dose THC and CBD medicine with a consistently reproducible formulation and an FDA orphan designation ready for human clinical trials.

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Persistent DEA Delays

Despite these FDA advancements, MMJ faces significant delays from the DEA in processing their application to grow strain-specific cannabis for pharmaceutical development. MMJ's President, Duane Boise, stated, "While there have been significant DEA delays, the court has not turned a blind eye to the patients suffering from MS and HD. MMJ has strictly followed federal laws to obtain the necessary FDA and DEA approvals for clinical trials to prove the efficacy of MMJ's drug."

DEA Anti-Marijuana Policy

Recently, President Joe Biden's health secretary, Xavier Becerra, stated that his agency "took action" based on available science and evidence, indicating that the decision now lies with the Department of Justice. Secretary Becerra suggested that DEA officials are not necessarily on board with the administration's plan to reschedule marijuana. At a recent event in Sacramento, he dodged questions about rumored pushback from the DEA. "We did our job," Becerra said of the recommendation in an interview, adding that the DEA "now has the final call to make that happen."

The Federal Mandate and Rescheduling Efforts

The HHS Secretary agreed with the recommendation to reschedule cannabis to Schedule III, acknowledging its medical value. This change would still require cannabis prescriptions to be issued by DEA-registered, state-licensed practitioners, and legitimate handlers like MMJ would need DEA registrations. MMJ BioPharma Labs has obtained a DEA Schedule I analytical lab license.

Legal Battle and Advocacy

MMJ BioPharma Cultivation has filed a federal lawsuit against Anne Milgram, Attorney General Merrick Garland, and several DEA personnel. The lawsuit emphasizes the critical importance of addressing DEA delays to facilitate clinical trials for Multiple Sclerosis and Huntington's Disease treatments. Tim Moynahan, the company's chairman, highlighted the urgency: "This federal case is of critical importance for patients and their loved ones suffering from MS and HD. We look forward to the full cooperation of the Federal Court, DEA, and FDA to alleviate patients' pain and suffering."

Scientific and Regulatory Challenges

Dr. Elio Mariani, MMJ's Chief Scientist, explained, "MMJ has followed the FDA's directives, ensuring our drug's chemistry is known and reproducible, supported by adequate safety studies, and conducting well-controlled studies to prove efficacy. We are confident in our compliance with FDA requirements." The FDA's review process for cannabis remains exceptionally stringent. The complexity of the cannabis plant, with its diverse chemical profiles, poses significant challenges for MMJ; however, the company has successfully produced identical batches for human clinical use.

Future Prospects

The FDA's rigorous requirements for data on drug absorption, metabolism, and toxicology will still apply, and the inherent variability of cannabis complicates the production of consistent trial materials. Rep. Andy Harris (R-Md.) and other lawmakers have expressed concerns about the reproducibility of cannabis chemistry, highlighting the diverse products available in state dispensaries. This variability underscores the challenges in standardizing cannabis for medical use that the states have not accomplished.

No Marijuana IS Being Grown

While MMJ faces DEA delays, Bright Green Corp. (Nasdaq: BGXX) also navigates its challenges in the cannabis industry. Bright Green has been working on its facility since 2022 and has yet to obtain DEA quota or produce any products. Along with Groff Hemp, Royal Emerald, Scottsdale Research, and other DEA registrants, none are cultivating pharmaceutical marijuana.

Bright Green Financial Woes

Bright Green recently published its first-quarter earnings, reporting no revenue and a deficit exceeding $48 million. The company highlighted its financial struggles, including a negative working capital of $4.6 million and insufficient funds to cover operating expenses for at least 12 months. Despite these challenges, Bright Green continues to compensate its executives handsomely.

MMJ's Next Steps

The ongoing delays and challenges faced by MMJ BioPharma and other DEA registrants highlight the complex landscape of cannabis research and production in the U.S. While all companies push forward in their respective efforts, MMJ remains the only company with FDA filings to prove efficacy in clinical trials. The medical potential of cannabis, coupled with the regulatory hurdles, underscores the importance of clear policies to advance scientific research and bring new treatments to patients suffering from debilitating diseases.

MMJ is represented by attorney Megan Sheehan.

CONTACT:
Madison Hisey
[email protected]
203-231-8583

SOURCE: MMJ BioPharma Cultivation

Topic:
Company Update
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