New Cannabis Therapy for Parkinson’s Seeks FDA-Approved Trials …

GB Sciences (OTCQB: GBLX), a cannabis company that cultivates and produces cannabis and conducts pharmaceutical cannabis research and development, is seeking Federal Food Drug Administration Approval for a ‘First-In-Human’ clinical trial–also known as a Phase 0 Clinical Trial, the initial human trial for a new medical product–for a cannabis-based therapy for Parkinson’s disease. They are planning on performing toxicology studies this year in preparation for submitting an Exploratory IND with the FDA – the next step in the process that leads to an approval for a clinical trial. They had earlier planned to perform a Nevada-based pilot trial instead of going through the FDA but decided the FDA route had a few key advantages, including quicker entry into international markets.

Although GB Sciences anticipates “It may be more difficult to register the First-in-Human trial with the US FDA in the short term,” presumably due to the current political climate

... read more at: https://www.potnetwork.com/news/new-cannabis-therapy-parkinson%E2%80%99s-seeks-fda-approved-trials

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