Thank you for the information, you have done a good deal of research. However, I noticed the FDA classification day was 10.September 2018, that is more than a year ago! the SP was up and down around AUD$0.01 and never over AUD0.03 for the whole year, it only started going up after the US reimbursement codes announcement, which means money is on the way!
FDA, CE, TGA - all regulations cleared, page-78
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