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Have we submitted an application to the TGA?, page-2

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T-Pain

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08/09/21

11:56

Post #: 55917554
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Originally posted by ollyolly: ↑

Seems to be a lot of confusion on whether ADO has submitted an application to the TGA.
Do we have ISO 13845 certification? Only information we have is that the audit process was completed.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02401548-2A1312773?access_token=83ff96335c2d45a094df02a206a39ff4

In the next months, we will be working with our distributors to ensure we have all the required
registrations for local health regulatory bodies within the territories in which we are operating. 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 1 3485 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.

3AW Interview yesterday
https://omny.fm/shows/mornings-with-neil-mitchell/3aw-mornings-with-neil-mitchell-7th-september-2021?fbclid=IwAR17UwVwvWbk_f6mLZ-SpNSMuGz-K1fwzb-fD2SuQpnDcU3KgNg2C0m-umE
1:38:55
Neil: How far off approval are you, do you think?

Derik: Pretty close, we submit our approval this month and we will be asking the TGA to expedite our approval. Once they finish assessing our test we will be in the market. So we are quite excited about that"

Expand

I am of the opinion that we have most likely received the updated certificate, but are waiting for the Indian trial results so as we can get TGA approval for both nasal and whatever "saliva" method they come up with.

If so, I'm guessing we will get the Indian results in the next few weeks with confirmation that these will be incorporated in the TGA application.

Last edited by T-Pain: 08/09/21

ADO Price at posting: 21.5¢ Sentiment: Buy Disclosure: Held
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