FF just asking about one point you have mentioned highlighted below.
[Yes is a puzzle but relying on my biotec investor experience the peer reviewed paper gets published, the partner and BRN ask for trial design, the regulator approves design and testing commences.] quote by FF
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It's been my experience on another stock[cannot remember which one now] that The COVID18 Analyser would be non-invasive, non medically ingested and as such actually does not come under the Regulatory regime at all (USA). Could be worth investigating that aspect.
Yak52
2020 BRN Discussion, page-19450
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