MMJ BioPharma is taking its fight for FDA approved cannabis medicine directly to DEA Administrator Terry Cole, as President Trump signals openness to marijuana's medical benefits. After seven years of delays, MMJ is ready to launch clinical trials for Huntington's disease and Multiple Sclerosis- if the DEA finally issues its long overdue API Bulk manufacturing registration.
WASHINGTON, DC / ACCESS Newswire / August 11, 2025 / MMJ BioPharma Cultivation announced today 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, acknowledging the complex nature of the debate and expressing openness to medical applications.
"Some drugs are okay, but we're trying to clean up crime. How does marijuana go hand in hand? We're only looking at that. That's early, but you know, somebody reported about marijuana reclassification, which is fine - we're looking at it. Some people like it. Some people hate it. Some people hate the whole concept of marijuana because if it does bad for the children, it does bad for people that are older than children.
But we're looking at reclassification, and we'll make a determination, I would say, over the next few weeks. And that determination, hopefully, will be the right one. It's a very complicated subject - the subject of marijuana.
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. For other things, I've heard some pretty bad things."
Seven Years of DEA Delays
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 (ALJ) proceedings. With no ALJ currently in place, the company is urging Administrator Cole to exercise his authority and approve the registration without further delay.
Why MMJ's Model Fits the President's Priorities
MMJ's approach directly addresses the balance President Trump emphasized between public safety and legitimate medical need:
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-separate from the recreational cannabis industry.
"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. The science is ready. The patients are waiting. All we need is the DEA to follow the law and issue our registration."
The Next Few Weeks Are Critical
With President Trump's announcement that a reclassification decision could come "over the next few weeks," 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. "This is the moment to prove that science, safety, and public health come first."
About MMJ BioPharma Cultivation
MMJ BioPharma Cultivation, a subsidiary of MMJ International Holdings, is developing proprietary, plant-derived cannabis pharmaceutical products for the treatment of Huntington's disease and Multiple Sclerosis. The company has received FDA Orphan Drug Designations, filed multiple IND applications, and operates in full compliance with FDA and DEA regulations.
MMJ is represented by attorney Megan Sheehan.
CONTACT:
Madison Hisey
MHisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/president-trump-signals-openness-to-medical-cannabis-mmj-biopharma-fi-1059109
