My email sent to the investor relations at 11:02am on 11/2/2022:With the announcement last week of the plan to move forward with Victorian manufacturing of CoviDx Rapid Antigen Tests starting next quarter subject to the Therapeutic Goods Association (TGA) approval, how confident is the company that such approval can be gained expeditiously given the timeframe that has already elapsed since the initial application was lodged?
As part of the arrangements with the Victorian government, have they offered/provided any assistance to Lumos to gain TGA approval?
Have Planet Innovation offered/provided any assistance to Lumos to gain TGA approval?
Assuming TGA approval is granted in the near term does the company have sufficient funds to commence production in Victoria with the assistance of the government, or will Lumos need to secure additional working capital?
The Vic Govt announcement and the subsequent ASX announcement reflected the nature of the discussions between the parties and the conditions precedent, namely the TGA approval of a self-test product. Given the nature of approvals and the fact that the TGA is an independent 3rdparty agency, we cannot comment on confidence levels. Please note that the self-test application is a separate application to the one that was previously lodged with the TGA and therefore, we will need to go through the process and monitor the level of engagement / prioritisation. The Vic government has been helpful in our discussions with the TGA to date and we hope to that this arrangement continues to help progress the initiative.
I think it is also important to highlight that the legal agreements are pending as stated in the announcement. This means that the plan and agreements can be subject to change based on our progress with the TGA. We will continue to work with the government and will make the necessary disclosures as milestones are achieved.
With respect to funding capacity, co-investments have been designed to coincide with the working capital commitments of the project. The board and management will continue to review our financial capacity and our ability to commit to a contract in light of other movements in the business at the time.
At 1:03pm the same day I replied seeking clarification:Thanks for the reply. With regards to this part:
Please note that the self-test application is a separate application to the one that was previously lodged with the TGA and therefore, we will need to go through the process and monitor the level of engagement / prioritisation.
Is this indicating that the TGA application for the self-test is currently going through the evidence gathering stage and has yet to be lodged with the TGA?
