There was one, maybe two blank pages with the otherwise very comprehensive Appendix. The Board have admitted that not enough data was available on the device itself (not the science behind it) to satisfy the stringent requirements of the TGA in last years application. Evidently the mixed group of Australian and French organisations they had on the job, overseen by former CEO Glen. Gilbert, could not pull it together.
Therefore, there is a new plan afoot, driven by major shareholder and temporary Executive Director Otto Buttula, to engage a US based Contract Manufacturing Organisation who will produce, and refine the kit, as well as collect the required data for both IVDR and TGA. A proven start to finish approach for what is after all a relatively simple immunoassay test kit.
The shares I bought as part of the capital raise for 10 cents each have one for two 20 cent Options attached which I'm looking forward to purchasing in due course. Obviously shares purchased on the open market don't have this significant bonus!
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