AT1 FY21 - General Discussion + FA, page-1825

Hi All,

Just a thought, would it be worth while formatting a standardised letter that could be distributed to the respective State and Federal Members of each shareholders electorate, asking the relevant MP to reach out to the TGA to progress the application made by Atomo Diagnostics for Self-Use Rapid Antigen Test for COVID 19 utilising the CareStart medical device?

I see a few valid reasons why this should be progressed on public health policy grounds. The first, given that we just received preliminary estimates of 25K new daily infections projected for the State of NSW to occur next month this will result in a excessively high level of demand for RAT. On top of this, considering that the domestic retail market for these tests are already experiencing supply constraints, the excess demand generated from 25K daily infections will no doubt result in added price pressures for the supply of all RAT currently available to the retailer market, resulting in higher check out costs to the consumer. This is based on the proven assumption that these devices work efficiently as a effective screening tool to capture infections across mass population groups.

Therefore, it makes perfect sense for the TGA to fast track the assessment of a sponsors application of a device that is has already received registered approval for self-testing under a different sponsored application made to the TGA by Pantonic Health. The perceived risk of a fast tracked application would be extremely low to the community. Finally, a company like Atomo Diagnostics who have already secured a 10mill supply agreement with Access Bio (the manufacturer of the medical device) would generate material benefit in addressing the worsening supply constraints of these tests to the public, especially when case numbers are on the cusp of exploding!

I only consider this to be a good idea on the assumption it might pressure the TGA to get the approval out this side of Christmas. Once the organisation breaks up for the year I doubt we'll see much happen until February next year. One person sending an email/letter to a politician is pointless, but hundreds sending the same thing might get them moving!