ColoSTAT® application for an Australian Register of Therapeutic Goods and TGA 26 page response
Dear Therapeutic Goods Administration,
I would like to obtain a copy of the 26 page response from the Therapeutic Goods Association with regard to an application made by an ASX listed company called Rhythm Biosciences Ltd (ASX code RHY) and/or Vision Tech Bio Pty Ltd for a product called COLOSTAT (a Colorectal Cancer blood test) to be entered on the ARTG.. The lodgement date of the application was on or around 12 May 2022. The response from the TGA and subsequent withdrawal of application by Rhythm Biosciences Ltd and/or Vision Tech Bio Pty Ltd was on or around 6 March 2023.
I am still an investor in Rhythm Biosciences Ltd and the company has not disclosed why it withdrew its application in detail. Obtaining this 26 page report will allow me to re-evaluate my investment.
I had previously requested a copy but misunderstood the response of withdrawing the request. My understanding was that someone else had requested similar information and for the request to move forward was that I withdraw my request.
Therefore my new request albeit very similar to the original request is above.
Yours faithfully,
Ragnar Lothbrok
Dear Mr Lothbrok
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has accepted transfer of your request
on 20 September 2023 for access to documents under the Freedom of
Information Act 1982 (FOI Act) as follows:
'I would like to obtain a copy of the 26 page response from the
Therapeutic Goods Association with regard to an application made by an ASX
listed company called Rhythm Biosciences Ltd (ASX code RHY) and/or Vision
Tech Bio Pty Ltd for a product called COLOSTAT (a Colorectal Cancer blood
test) to be entered on the ARTG.. The lodgement date of the application
was on or around 12 May 2022. The response from the TGA and subsequent
withdrawal of application by Rhythm Biosciences Ltd and/or Vision Tech Bio
Pty Ltd was on or around 6 March 2023.’
Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 20 October 2023. Due to the statutory processing time afforded
under the FOI Act in which to provide you with a decision in relation to
your FOI request, we would be grateful if you could please monitor your
emails periodically for updates regarding your request.
Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.
Personal information:
Documents containing the personal information of third parties (e.g. the
names and contact details of any individuals, or any information that
could reasonably identify an individual) may require the Department to
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grateful if you would consider removing the personal information of third
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In addition, please note that as mentioned in our earlier correspondence
(FOI 4371), a decision was made not to publish the documents relevant to
that request, and as such the FOI team will be able to process the request
expeditiously and without charges.
I would be grateful if you could respond to this email by Friday 29
September 2023 so that we may continue processing your request.
If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].
Kind regards
Emily
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [2][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [3]www.tga.gov.au
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From: Ragnar Lothbrok [7][FOI #10701 email]
Sent: Wednesday, 20 September 2023 4:36 PM
To: FOI [8][email address]
Subject: Freedom of Information request - ColoSTAT® application for an
Australian Register of Therapeutic Goods and TGA 26 page response
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Dear Therapeutic Goods Administration,
I would like to obtain a copy of the 26 page response from the Therapeutic
Goods Association with regard to an application made by an ASX listed
company called Rhythm Biosciences Ltd (ASX code RHY) and/or Vision Tech
Bio Pty Ltd for a product called COLOSTAT (a Colorectal Cancer blood test)
to be entered on the ARTG.. The lodgement date of the application was on
or around 12 May 2022. The response from the TGA and subsequent withdrawal
of application by Rhythm Biosciences Ltd and/or Vision Tech Bio Pty Ltd
was on or around 6 March 2023.
I am still an investor in Rhythm Biosciences Ltd and the company has not
disclosed why it withdrew its application in detail. Obtaining this 26
page report will allow me to re-evaluate my investment.
I had previously requested a copy but misunderstood the response of
withdrawing the request. My understanding was that someone else had
requested similar information and for the request to move forward was that
I withdraw my request.
Therefore my new request albeit very similar to the original request is
above.
Yours faithfully,
Ragnar Lothbrok
-------------------------------------------------------------------
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Dear Ragnar Lothbrok
Please find attached correspondence in relation to your Freedom of
Information request.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
[3][IMG][4][IMG][5][IMG]
Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.
The Department of Health acknowledges the Traditional Custodians of
Australia and their continued connection to land, sea and community. We
pay our respects to all Elders past and present.
"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information.
If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you
receive this transmission in error please notify the author immediately
and delete all copies of this transmission."
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