More valuable info. No FDA Approval. All FDA work is halted, per IMDS. From Page 55 of IMDSs 10Q released yesterday. http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=9296931 Progress toward re-submitting a PMA application during Fiscal Year 2012 and the ten months of Fiscal Year 2013 was significantly delayed and then eventually halted simply due to lack of funding to hire the necessary FDA consultants required to assist in the process.