Accounting for errant supply chains that let their ISO Audit lapse due to Covid-19 restrictions was an inhibitor and outside Anteotech's control. ISO Audits are about the whole kit and caboodle, and unfortunately there are no gimmes in ISO Audits.
As for folk questioning TGA EUA approval 'Oversight' - there was NO foreseable OZ market ATT - ATARG, Pollies, TGA and National, NSW & Vic Expert Advisors were dismissing RATs out of hand until they were drowned in a flood of evidence. Ellume's Sean Parson bashed his head against belligerent "Experts" without effect so why would AnteoTech waste its time. Yes "They" finally conceeded there was a place for RATs, however in the meantime AnteoTech nurtured and won a fist full of Country and Regional distributors agreements (with more to come?), and got a better structured (non EUA) FULL TGA Approval Application together and submitted.
With ISO in place, the new Advisors & Executive, and endorsement from one of the few enlightened Experts Mary-Louise McLaws, at hand - the road to TGA and others Regulatory Entities' approvals should be smoother.
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