Any positives?, page-95

I agree with your post Slippin. The science hasn't changed only the timelines.

The TGA and EU Common List requirements are changing monthly and becoming more stringent. The company has been caught up in the revised changes and has had to quickly organise clinical trials. Everyone seemed to expect these trials to be completed quickly but in reality they take around 6 months to complete and submit. The Company has never said how long these trials will take in any announcements.

The problems with RAT testing started to surface around December 2021 and with the new Omicron Strain, WHO and MDCG developed new guidelines for regulatory approval. So many companies have now had their regulation rejected because they haven't provided clinical data. This was included in the slides yesterday.

*TGA post market surveillance currently being conducted by
Doherty Institute, with the current focus on variants of
concern. Stringent post market surveillance is expected in the
future.
• EU Common List is updated monthly – it has removed 10 test
and ~180 test rejected for not meeting MDCG guidelines.1
• Independent evaluations undertaken by the German Paul
Ehrlich Institute have found that, out of 245 tests analysed 46
did not meet the criteria. 2

Unfortunately, Derek presented the information poorly yesterday and focused on the reasons for delays. Some of which were out of his control and not providing enough detail in previous announcements. Even if he tried to spin this differently he would have been found out.

It was the emphasis on delays and possible uncertainty with TGA and EU Common List approval that caused panic in the market.

The Company is confident they have a quality product and have ISO accreditation to prove it.

The current market price is below the 52 week low and one needs to assess whether the company has gone backwards that far. I don't think so.

COVID is so dynamic and we are going to see more changes and problems in the future. Because there are so many RAT tests picking up false negatives and positives, I would not be surprised to see them removed from point of sale and back to relying only on PCR testing.

The medical profession will only want accurate and proven technology. I still have confidence in our science and technology that it will compete with PCR testing.

The share price is creating a good opportunity for a hostile take over.