Cannabis researcher MMJ International Holdings Corp recently reached a milestone when it officially submitted requested responses to the U.S. Food and Drug Administration (FDA) regarding its cannabis formulation. This submission comes in response to an FDA notification highlighting chemistry, manufacturing and control (CMC) concerns.
Dr. Elio Mariani, MMJ's chief scientist, expressed confidence in the submission, stating that it comprehensively addresses the CMC questions related to its all-natural plant-based soft gel capsule containing THC and CBD. These responses were pivotal as they paved the way for MMJ's forthcoming clinical trials for conditions such as multiple sclerosis and Huntington's Disease, per a press release.
MMJ's president, Duane Boise anticipates significant developments upon approval. He notes that MMJ International Holdings, along with its subsidiaries MMJ BioPharma Cultivation and MMJ BioPharma Labs will become one of the few federally legal companies approved by both the DEA and FDA. This approval extends to their capacity to cultivate, manufacture, transport, import and export cannabis for pharmaceutical development and clinical trials.
MMJ BioPharma Labs, with its DEA Analytical Lab Registration for Schedule 1 drugs, assumes a prominent role in cannabis research and development. However, it is worth noting that MMJ continues to face delays in the DEA approval process for MMJ BioPharma Cultivation's API Bulk Manufacturing registration, leading to litigation.
Chairman Tim Moynahan emphasized the significance of these achievements, underlining the need for safe and reproducible marijuana medicine to set the standard for reliable results in clinical trials.
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