In my opinion, their strategy of taking the non-FDA pathway...

In my opinion, their strategy of taking the non-FDA pathway raises concerns given that US and Europe are by far the biggest end markets. Shortcuts, such as the UK market entry and failed TGA strategy, compromise the perceived legitimacy of their product albeit the data looks promising peovided the n is increased. If you come on as a commercialization expert, you should shoulder greater responsibility for strategic commercialisation failures, especially as the focus should have been on markets with higher standards like FDA and UK, rather than shortcuts with lower standards. The blame on TGA's adoption of the IVDR appears to be a weak deflection from strategic shortcomings. Regulatory changes involve prolonged engagement with key opinion leaders and a proactive strategy (based on brief desktop research IVDR was first contemplated in 2017 before adoption in 2022), essential for avoiding setbacks and preserving shareholder value. They really should have pivoted the commercialisation strategy to IVDR and had active engagement with TGA, albeit OB arguably had some insight when he sold $6.5m of stock reducing his cost base to negative I.e., no longer any skin in the game.