General Discussion - News - Questions, page-2

That is news to me. I didn't know they lodged a separate application. Can you please tell me when you directed that question to Lumos and how you phrased it? Can you also tell me the date they responded you with the above reply?

I received the below response to my query from Lumos regarding their TGA application.

'Many thanks for your email. Lumos is still actively working with the TGA to secure the necessary approvals required for the proposed project with the Victorian Government to go ahead. As we stated in our release, this requires clearance from the TGA for the over-the-counter (OTC), rather than professional, use of the test. In addition performance characteristics for the test, this also requires providing supporting information and documentation covering its use by less experienced (ie at home) users.

This is an interactive process and, due to the indicated support from the State Government, the TGA has been very engaged with the Company in managing its application. As such, there has been regular, ongoing dialogue including the provision of additional information by the Company at times in order to support the process. This is maybe different and a bit more dynamic to what you have seen previously for other applications in which the regulatory bodies review, ask for additional information to address particular concerns, and then make a decision once the additional information has been received and evaluated.'

I received the above response on the 22nd of February.