Ann: Investor presentation, page-4

The presentation has provided a satisfactory explanation for the FDA delays. I see most FDA applications get delayed. Whilst disappointing, one shouldn't be too surprised by it. The most disappointing thing last year was the cancellation of the sales contract in Wales in the UK due to implementation delays. I think the lack of end-to-end 3base instrument is hindering the uptake, as the implementation of the workflow with generic PCR machines appears to be complex. The company could have developed the end-to-end 3base PCR machines earlier, although it probably meant that more shareholder dilution and bigger capital raising would have been required. I hope the company will soon achieve prototype success for the machine development project.
The granting of the first FDA approval, once achieved, will be transformational for the company. As seen with a number of other players like Nanosonics, Avita Medical and the now privatised Sirtex Medical, all new medical technologies tend to be taken up much faster in the US, while Europe and Asia sales typically lag and grow only slowly. US sales will decide the success or failure of this promising company.
Looking at the numbers, the company is currently doing non-covid sales at roughly 15m a year, and mostly from Australia. That's not bad. FDA and US sales success could soon see sales at 10 times this level. And given the economics that we had glimpsed during the pandemic, the company will be very profitable by then. And with the long product pipeline, it could become a big winner.
There is light at the end of the tunnel. One just need to hope that it is not the light of an oncoming train