Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-47

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LifeCrisis

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30/04/24

18:04

Post #: 73590929
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Originally posted by FindMyBroker: ↑

Having said that though, re your point " FDA will assess results and likely issue CLIA waiver in the following year 2025.", i am convinced he said 2026 in the vid, and i listened back a couple of times to be sure (hence my wondering if he got himself mixed up with his flu seasons, as I definitely want to believe it is earlier than that).

He may be discussing flu season 2025-26? As in September 2025-Feb2026?

Not sure. May require clarity. This is what I sent to IR:

Hi Jane,

Trust you have been well.

I seek some guidance and clarity on this article from Foster Stockbroking around the latest 4C and commentary around the CLIA waiver for Febridx.

CLIA waiver progressing. Key to unlocking FebriDx's full potential is obtaining a CLIA waiver from the FDA. This confers huge potential to expand the market for FebriDx beyond its current remit limited to ER and urgent care facilities. LDX estimates the waiver could see FebriDx's target market rise from 18k sites currently to >220k.The company is readying administration for the CLIA waiver study which should be finalised by June, with first patient expected in September.
https://www.listcorp.com/publisher/foster-stockbroking/hologic-enables-maiden-net-free-cash-flow-3024654.html

I don't recall any discussions from management or in the releases confirming that CLIA waiver should be finalised by June and I'm hoping to confirm the expected status of CLIA Waiver? I believe this could be a primary driver in a re-rate of the share price and shareholder value. Given there has been no advancement since the release of recent news and the quarterly reporting (in fact, a continued down trend in value) I am wondering whether this comment (somewhat material) should be released to the market?

Is the company conducting a further study (how many do we need??!) throughout September to ensure the CLIA waiver? How long is the study expected to take and what is the company's expectation on release of the waiver?

Further to the above (not sure if anyone is reviewing the hot copper pages (i can understand if not) is there any expectation around the management/director investment into the company via direct share purchase? We can see that management does hold some small interest in direct stock ownership however, I am sure that further direct share purchasing at current level would be reasonable by management to show support to the brand being built and its future indications for success.

I appreciate any response provided.

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Excellent, and thanks for posting the content.

I had also asked re the size of the cohort of patients needed for the trial and when they would expect to have it filled (i.e. first being September, but how long to get the full quantity, however many they may be?) although i don't have direct contact details so just went via the contact us page re investor question, so not sure how likely i am to get a response compared to your much better communication.

If i do get any response i will post it.

LDX Price at posting: 5.0¢ Sentiment: Buy Disclosure: Held
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