9th Circuit Court of Appeals Orders DEA to Respond to MMJ’s Writ of Mandamus Within 30 Days
WASHINGTON D.C. / ACCESSWIRE / October 3, 2023 / Attorney Megan Sheehan representing MMJ BioPharma Cultivation last month filed suit against the DEA for “dragging their heels” for the approval of MMJ’s API Bulk Manufacturing Registration to grow pharmaceutical marijuana needed to produce its medicine. Today the 9th Circuit Court of Appeals ordered the DEA (Drug Enforcement Agency) to respond within 30 days.
MMJ BioPharma Cultivation, MMJ Biopharma Labs , MMJ International Holdings, are the leading Pharma cannabis companies that have FDA Investigational New Drug (IND) filings to conduct clinical trials in Multiple Sclerosis and Huntington’s disease. MMJ has completed manufacturing of its proprietary dose form, THC and CBD non-synthetic soft gelatin capsule developed from marijuana plant extracts. MMJ has submitted its proprietary formulation to the FDA for approval to utilize its medicine in human clinical trials. To date MMJ is the only company with a final dose THC, CBD formulation ready for clinical trials. Duane Boise the companies President stated ” while there has been significant DEA delays on processing MMJ’s application to grow strain specific cannabis for development of its pharmaceutical, the court has not turned a blind eye on the patients suffering from Multiple Sclerosis and Huntington’s disease. MMJ has been strictly following the current federal laws to obtain the FDA and DEA approvals necessary to preform clinical trials to prove efficacy of MMJ’s drug. “
DEA CONTINUES DELAYING MMJ CLINICAL TRIALS
Last October President Joe Biden asked the Secretary of the Department of Health and Human Services (“HHS”) and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.
Bloomberg News reports that the National Institute on Drug Abuse agreed with the recommendation and he Health Human Services Secretary recommended that the DEA reschedule cannabis to a schedule III. By doing so the HHS Secretary has made a determination that cannabis does have medical value.
Cannabis in schedule III would still require a prescription issued by a DEA-registered, state-licensed doctor. Legitimate handlers in the cultivation, manufacturing and distribution chain would have to obtain registrations from the DEA like MMJ. Registrants would have to create and maintain inventory and transaction records, file certain reports and maintain adequate security. Schedule III placement would loosen registration requirements for cannabis researchers.
Tim Moynahan the companies chairman stated “This federal case is of critical importance for the patients and their loved ones suffering from Multiple Sclerosis and Hutchison’s disease. For that matter, any advocate of health care and scientific research, committed to discovering new modes of treatment for disabling diseases, will be vitally interested in the progress and speedy resolution of the issues presented. We look forward to the full cooperation of the DEA and FDA. Ultimately, MMJ’s goals coincide with the health and well being of patients by ameliorating the causes of their pain and suffering.”
Dr. Elio Mariani, MMJ’s cheif scientist stated “MMJ has followed the FDA’s directives and we feel confident that we have fulfilled the FDA’s request that 1. MMJ’s drug chemistry is known and reproducible; 2. that there is a preponderance of adequate safety studies; 3. that MMJ will be conducting well-controlled studies to prove efficacy; 4. that the drug is accepted by qualified experts; and the scientific evidence is widely available.
MMJ’s scientific breakthroughs and new research are now underway and MMJ BioPharma Cultivation will ensure that schedule 1 DEA approved researchers will soon be able to obtain their specific cannabis strains for clinical trials.
MMJ is represented by Attorney Megan Sheehan of Rhode Island.
For more information on MMJ, please visit www.mmjih.com.
Contact: MMJ
Madison Hisey
Email: mhisey@mmjih.com
203-231-8583
SOURCE: MMJ International Holdings
View source version on accesswire.com:
https://www.accesswire.com/789357/appeals-court-orders-dea-on-mmj-marijuana-lawsuit
Charlotte, North Carolina--(Newsfile Corp. - December 23, 2024) - cbdMD, Inc. (NYSE American: YCBD) (NYSE…
AUSTIN, TEXAS / ACCESSWIRE / December 23, 2024 / Interactive Strength Inc. (Nasdaq:TRNR) ("TRNR" or…
Originally published in Quest Diagnostics' 2023 Corporate Responsibility ReportNORTHAMPTON, MA / ACCESSWIRE / December 23,…
Marlborough, Massachusetts--(Newsfile Corp. - December 23, 2024) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage…
WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotech company developing the world’s most…
WESTON, Fla.--(BUSINESS WIRE)--ILiAD Biotechnologies, LLC (ILiAD), a clinical stage biotech company developing the world’s most…