Toxicology Study for GRAS Compliance Completed
The 90-day toxicology study necessary for GRAS compliance has been completed. Although the live animal portion concluded in early December 2017, the clinical analysis and histopathology work consumed another 90 days, followed by biostatistical analysis and report drafting. ZIVO R&D director Dr. Amy Steffek received the draft report from Product Safety Labs (PSL) on Monday, March 19 for initial review and comment. The Company is expecting the final, signed PSL report by the end of March 2018. Initial review finds no unusual or adverse results reported. In mid-2017, the rat study was delayed by availability of algal biomass due to unseasonably hot summer and early fall weather in Southern California, where Synthetic Genomics, Inc. (SGI) was cultivating ZIVO strain algae in outdoor ponds.