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3.13%

6.2¢ rhythm biosciences limited

Ann: Suspension from Official Quotation, page-64

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josiejow37

280 Posts.

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06/03/23

07:23

Post #: 66615736
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Originally posted by ShmoShady: ↑

“You’ll receive an automated email advising that your application has been successful.” (Or rejected)

from here:
https://www.tga.gov.au/resources/publication/publications/medical-device-inclusion-process/step-7-processing-your-application

It could also be possible that ‘the submission’ has been selected for audit. An audit is mandatory for IVDs in certain circumstances. Circumstances are here:
https://www.tga.gov.au/resources/resource/guidance/auditing-medical-device-including-ivd-medical-device-applications

One of particular note that means an audit actually has to take place is:

“An IVD medical device that is intended to be supplied for use in a national screening program”

So it’s either been approved, not approved or selected for audit (perhaps for the reason above, because it’s mandatory)

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Great research!

I imagine TGA would only audit applications that they intend to approve. If they deem an audit necessary after processing the application for 10 months, then it could well be the final step in the approval process.

A delay announcing an audit to stakeholders may be because more information is required from TGA to ensure the announcement meets the ASX rules.

RHY Price at posting: 96.0¢ Sentiment: Buy Disclosure: Held
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0 Great analysis

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Last 6.2¢		Change -0.002(3.13%)		Mkt cap ! $15.41M

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