Thanks for getting in touch and I hope all is well with you also.
With regards to the Foster report and the statement that you have highlighted (per the below):
“The company is readying administration for the CLIA waiver study which should be finalised by June, with first patient expected in September.”
In previous announcements, we have stated that a pathway has been established with FDA to pursue CLIA Waiver for FebriDx. This would involve running a study where a trained user performs the test next to an untrained user. We expect that this one study should be sufficient based on discussions with FDA to date, which have all been helpful.
Before we can start the study, we need to engage a Clinical Research Organisation (CRO – referred to as “administration” above) to undertake the study.
We would like to engage a CRO and have administration ready by June 2024. Presuming this is completed on time, we would like to commence the study by the upcoming US flu season which will commence around September 2024. Time to complete the study is dependent on the positive rate of bacterial and non-bacterial infections and having the positive patients identified in the study. We hope that would be over the 2024 – 2025 US winter flu season. If we are successful in the number of positive patients and achieve our performance endpoints we would hope to have the FDA add the CLIA Waiver claim to our intended use by the flu season 2025-2026. As with anything forward looking, these are targets / estimates. Once we have something more definitive to announce on the next steps, we will look to lodge an ASX release. I hope this helps clear up any confusion.
Your comments re management / board supporting the share price are respectfully noted and have been passed onto the Board.
As I assumed, the flu season Doug mentioned in the video around having CLIA available is October 2025 - February 2026 US Flue season if all goes well.So on the back of this anyway, LDX will have Febridx and Viradx selling in current available markets as it was so we could guesstimate revenue once the flu season starts again and assume that primary revenues will be from the Viradx sales.
In the short term, we would be assuming next quarter:
- $5MillionUSD Hologic second payment (cash receipt)
- Updates / further revenue from FFN stage development
- $1.5MUSD in recognised revenue from initial $5MUSD received in Jan. Other services income could be circa $1.8M+USD for ongoing services contracts.
- Potential product release for the IVF hormone test (refer below)
In the Mid Term:
- Further updates on development and trials for FFN product
- Study updates around CLIA waiver for Febridx
- Distributor agreements for Febridx/Viradx in the US (comment again made in recent video with Doug). Also a number of conventions attended and to attend this CY.
- Potential AU distributor agreements for Febridx/Viradx (mentioned previously by Doug)
- Potential new services agreements with other brands
In the long term:- CLIA Waiver for Febridx opening up sales channel to 200,000+ office locations
- FFN product launch with Hologic
- Potential AU product sales if the above AU distributor agreements come to fruition
- Potential updates on Aptatek PKU clinical trials etc.
All in my opinion and supported by interpretation of ASX releases / clinical trial websites etc.
