Nexien BioPharma is proceeding with pre-clinical and clinical drug development activities, in accordance with U.S. Food and Drug Administration ("FDA") protocols, for a number of pharmaceutical formulations that include cannabinoids.
BioPharma’s drug development strategy consists of:
1. The determination of medical conditions and disorders that could potentially benefit from cannabinoid-based formulations;
2. Conducting “freedom to operate” investigations on these conditions;
3. The preparation of patent applications and the prosecution of such application and/or the licensing of existing patents;
4. Identifying the regulatory pathway with the U.S. Food and Drug Administration (FDA); and
5. Proceeding with pre-clinical and clinical development activities in accordance with FDA protocols for submission to investigate and ultimately obtain approval for the particular product(s).
Nexien BioPharma is currently researching and developing proprietary pharmaceutical formulations consisting of different cannabinoids and terpenes.
Due to the legal and regulatory challenges in researching cannabinoids derived from the cannabis plant in the United States, Nexien BioPharma is initially focused on developing drugs utilizing synthetic cannabinoids. If the Company intends to proceed in researching pharmaceuticals derived from the cannabis plant, it will proceed with the research and trials in a country where the research is legal, such as Israel, and not in the U.S.