MMJ BioPharma Cultivation announced it will file an emergency motion directly to newly confirmed DEA Administrator Terrance "Terry" Cole, seeking immediate action on the company's long-delayed application to grow pharmaceutical-grade cannabis for FDA-approved clinical trials in Huntington's disease and Multiple Sclerosis. The move comes just hours after President Donald Trump addressed the nation on marijuana rescheduling, expressing openness to medical applications.
Presidential Support for Medical Cannabis
President Trump acknowledged the complex nature of the marijuana debate while signaling potential support for medical applications. "I've heard great things having to do with medical, and I've heard bad things having to do with just about everything else. But medical - for pain and various things - I've heard some pretty good things," Trump stated during his national address.
The President announced that a reclassification decision could come "over the next few weeks," describing marijuana as "a very complicated subject" while emphasizing the distinction between medical and recreational use.
Seven-Year Regulatory Standoff
MMJ BioPharma's application to become a DEA-registered bulk manufacturer has been stalled for over seven years due to inconsistent guidance, procedural irregularities, and unconstitutional Administrative Law Judge proceedings. With no ALJ currently in place, the company is urging Administrator Cole to exercise his authority and approve the registration without further delay.
"President Trump's remarks recognize that there is a legitimate place for cannabis in medicine when it's held to the same standards as any other prescription drug," said Duane Boise, President & CEO of MMJ BioPharma Cultivation. "Our work is about delivering safe, consistent, FDA approved medicine to patients in need-not about recreational sales."
FDA-Approved Development Pipeline
MMJ's approach directly addresses the balance President Trump emphasized between public safety and legitimate medical need through several key regulatory achievements:
- FDA Orphan Drug Designations for both Huntington's disease and Multiple Sclerosis
- Two Investigational New Drug (IND) applications on file with the FDA
- Good Manufacturing Practice (GMP) compliance ensuring safety, purity, and consistency
- Full alignment with federal law, operating separately from the recreational cannabis industry
The company, a subsidiary of MMJ International Holdings, is developing proprietary, plant-derived cannabis pharmaceutical products specifically for treating these neurological conditions.
Critical Timing for Cannabis Policy
With President Trump's announcement of an imminent reclassification decision, MMJ sees a historic opportunity to align federal cannabis policy with rigorous, science-based medical development. "If Administrator Cole acts now, the DEA can lead-not obstruct-America's transition to regulated, pharmaceutical-grade cannabis for legitimate medical use," said Boise.
The company emphasizes that its model fits within the President's priorities by maintaining strict regulatory compliance while addressing legitimate medical needs. "The science is ready. The patients are waiting. All we need is the DEA to follow the law and issue our registration," Boise added.
MMJ BioPharma operates in full compliance with FDA and DEA regulations and is represented by attorney Megan Sheehan. The company's emergency motion represents a direct appeal to the new DEA leadership to resolve the prolonged regulatory impasse that has prevented advancement of potentially life-changing treatments for patients with Huntington's disease and Multiple Sclerosis.
