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Tuesday, May 16, 2017 11:42:32 AM
https://www.bloomberg.com/press-releases/2017-05-16/plandai-biotechnology-announces-phytofare-to-be-focus-of-human-clinical-trial-for-type-ii-diabetes-in-mauritius
Based on the outcome of the clinical studies, Protext will submit its findings to the United States FDA under their Botanical Drug classification to apply to obtain clearance to market Phytofare(R) specifically for treating Type II diabetes. Botanical drugs are subject to fewer requirements by the FDA and can obtain clearance much faster and with significantly less cost. The human clinical trial is an important milestone in obtaining a diabetes claim that would position Plandai as the exclusive supplier to a market where 12% of global health expenditure is spent on diabetes ($673 billion). We anticipate that Protext will release a Phytofare(R)-based product to market before the end of the year with structure function claims while awaiting the clinical trial results and FDA claims specific to treating diabetes.
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