林业发展局核准的MMJ生物药厂尽管符合所有法律要求,但仍等待联邦批准2 500天,违反了60天审查任务。 The FDA-approved MMJ BioPharma awaits federal approval for 2,500 days despite meeting all legal requirements, violating a 60-day review mandate.

司法部在9月承认DEA的内部法院违宪, 凸显了MMJ生物制药的联邦许可申请停滞不前, 尽管满足所有法律和监管要求, 包括FDA的孤儿药物指标和I计划研究许可, 但该公司已经等待超过2500天的批准. The DOJ’s September admission that the DEA’s internal courts are unconstitutional has spotlighted the stalled federal license application of MMJ BioPharma, which has waited over 2,500 days for approval despite meeting all legal and regulatory requirements, including FDA orphan drug designations and a Schedule I research license. 这一拖延违反了2022年《医学大麻病和Cannabidiol研究扩展法》规定的60天审查任务,阻碍了对亨廷顿病和多发硬化症的大麻素治疗的关键研究。 The delay violates the 60-day review mandate of the 2022 Medical Marijuana and Cannabidiol Research Expansion Act, hindering critical research into cannabinoid treatments for Huntington’s disease and multiple sclerosis. 随着SAGE-718试验第二阶段失败的迫切性日益增加,专家们敦促特朗普总统采取行动,批准MMJ的许可证,设立缉毒署医学研究司,确保司法部的监督,使联邦政策与科学和法治相一致。 With a failed phase 2 trial for SAGE-718 increasing urgency, experts urge President Trump to act—by approving MMJ’s license, creating a DEA medical research division, and ensuring DOJ oversight—to align federal policy with science and the rule of law.