Further to my post, it's important to note that the company has not previously engaged a Contract Manufacturing Organisation (CMO). They previously attempted to submit for TGA using a variety of external Australian consultants alongside French manufacturer Biotem. This time around, they are essentially engaging a 'one stop shop', based in the US, to complete the whole task through to the regulatory IVDR/TGA application. I believe the Board will have selected an experienced CMO, with a proven record of success, of which there are many in the US, bearing in mind that Colostat is a simple ELISA immunoassay test.
An interesting aside is that the ELISA test diagnostic market is forecast to hit US$4 billion by 2030 (worth US $2.35 billion in 2022).
RHY Price at posting:
9.9¢ Sentiment: Buy Disclosure: Held
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