The following few paragraphs caught my attention and gave me a hint on what is really happening in the Health Sector compared to the Political Sector.
In vitro diagnostic (IVD) manufacture is heavily regulated. To operate in chosen markets successfully,
organisations must ensure ongoing supply of product of the highest quality and performance. The
products must be fully supported by the manufacturer and integrate the support of OEM suppliers,
distributors and supply chain organisations. Any questionable aspect of quality or support will risk
scrutiny by regulatory authorities whilst in market and this could lead to penalties and / or removal of
product from the market. Many organisations close to AnteoTech have been the subject of such
scrutiny and been forced to remove product batches or entire products from the market and this has
caused the organisation valuable reputational damage that will hinder further developments.
To ensure compliance with regulatory requirements and ensure product quality is maximised, it is best
practice to build processes from product development through manufacturing, distribution, product
support and market surveillance that are fully integrated. This requires the involvement of all parties in
the chain, including, in the case of AnteoTech, distributors around the world, an outsourced
manufacturer in Spain and OEM’s such as Axxin and others supplying component parts of our product.
It also requires the company to develop products aligned to development procedures recognised by
regulators. The standard required by regulators to assess adherence to market operations and
development is ISO13485. AnteoTech graduated to legal manufacturer level of this standard in
September 2021.
To be able to confidently supply a volume of product into any market, a legal manufacturer must
integrate three primary elements being Manufacturing, Distribution and Quality Management. Any
scaled selling of product carries considerable commercial risk if the integration of these elements is
not robust. Whilst we recognise that there has been a significant and immediate imperative to turn on
sales to support the Life Science business, we have balanced our progression to ensure we also protect
long term security of the business. We are now confident that we have progressed these elements to
the point that our scaled selling risk is reduced.
Risk Management and reputational damage are extremely important and whilst it is frustrating for the company and shareholders that the TGA have added additional requirements relating to clinical trials, it is extremely important that the approval results in a superior and more reliable product in the market place. The medical profession and the Health Sector only want products that are accurate and reliable.
The push for rapid antigen testing (RAT) has only come about because the politicians wanted the country opened up after vaccination targets were achieved. (Western Australia excluded). When Omicron numbers surged, PCR testing could not keep up with the demand for testing mainly due to border travel requirements. Hence, RAT was seen as the answer. If these demands were not so high then I doubt whether RAT testing would be in demand because I still believe the Health Sector officials are still very concerned about RAT testing. False positives are very dangerous for the community.
The TGA are now requesting further proof from RAT manufacturers about the validity of their tests to pick up new variants. My sister works in the Health Sector and she is continually complaining about the RAT tests that are indicating negative results when PCR is picking up positives albeit several days later. Hence, reputational damage and the likelihood that approvals will be revoked if at home tests cannot meet updated requirements is very real.
In my opinion, I would not be surprised that several RAT manufacturers will have their approvals revoked and their products removed from sale. This is what is highlighted in the quarterly commentary.
Whilst the last few days has been frustrating for shareholders, it is more important that our product passes all the quality standards and becomes a go to product in the Health Sector.
The share price shot up on hype and political sentiment towards rapid antigen testing and lack of supply.
RAT will be important in the market but only reliable products will survive over time.
Sure the progress of the company appears to be slow and the revenues are lower than most expected but I have never heard management say in any communication that they are making significant revenues. The company appears to be confident in getting TGA approval and when it does achieve approval, revenues will rise but I still believe it will be gradual and only year on year growth will attract significant interests in the market.
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- Ann: Quarterly Update / Appendix 4C
Ann: Quarterly Update / Appendix 4C, page-128
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