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hotcopinvestor

2,676 Posts.

160

08/08/21

20:26

Post #: 55125423
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Originally posted by vein1: ↑

TGA approval of the EuGeni™ Rapid Diagnostic Platform will be invaluable to the success of the product.

IMO, the most important statement in the CEO's recent report was:
"To ensure we continue to meet the high standards required to fulfil these regulatory requirements,
we have been working to enhance our Quality Management System and ISO 13485 certification.
During the quarter, we announced we had pulled forward our annual compliance audit to
receive the annual certification earlier. Today I can report that the physical ISO 13485 audit
process has been completed successfully, and this paves the way to progress our certification
status for primary regulatory processes.
Once we have received the ISO 13485 audit certificate from the independent auditors, we will
submit our EuGeni registration request to the Therapeutic Goods Administration (TGA). The timing
of registration with the TGA is anticipated in Q4 and is dependent on the time required by the TGA
to process the application."

This will open up mass sales in Oz as well as the rest of the world. The way the Delta variant is spreading, it won't be a moment too late.

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To clarify your post vein1, TGA approval for EuGeni will not be before 1st of October?

ADO Price at posting: 21.0¢ Sentiment: Buy Disclosure: Held
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