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FA/General Discussion, page-17

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FinFree101

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26/11/21

08:45

Post #: 57870080
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Originally posted by Surandy70: ↑

Thanks for sharing that, I got the email earlier today about it being available but am only now getting the time to sit down and listen to it.

Very informative, quite technical in a lot of the information, reinforces what they have said previously, such as in their annual report, quarterly report and presentations but provides more context and clarity.

I liked how they said about having a strong focus on costs and even achieving some cashflow positive months. They were very clear that the 2021 annual results only included 1 month of contract manufacturing and so expect to see the revenue mix change over the coming months and years. Contract manufacturing is higher margin revenue and their own branded products are even higher again.

What caught my ear was at about the 17m15s mark where Rob states "there's a 510(k) clearance coming with FebriDx in the next several weeks".

A 510(k) clearance is the USA's FDA regulatory clearance and it was the EUA de-prioritising the FebriDx test that prompted the sell off earlier in the year. The EUA was an attempt to allow early sales/use of theFebriDx tests prior to full 510k clearance.

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Hiya, slight correction if I may.

The US FDA de-prioritised their CoviDx EUA app, not the FebriDx application. LDX company has applied only for the full 501(k) approval for FebriDx test from the beginning and this seems to be continuing with no issues yet (as you heard the CEO mention its expected in near future).

The CEO also answered my initial Q about why the CoviDx EUA was de-prioritised and he confirmed it was due to the US FDA seeking to approve OTC tests for the US infection control needs (and presumably their CoviDx test and commercial plan didn't fit that immediate need)

LDX Price at posting: 83.0¢ Sentiment: Buy Disclosure: Not Held
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0 Great analysis

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FA/General Discussion, page-17

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FA/General Discussion, page-17

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