Antibotter,Generally, I wouldn't comment on another company’s...

Antibotter,

Generally, I wouldn't comment on another company’s product, but since you have posted this on the FRE page and implied that Firebrick might be financially at risk because of the product, I am compelled to correct the misinformation.

The product you refer to is approved in Europe as a medical device and claims to be seeking approval in Australia also as a medical device.
Medical device approvals tend to be faster and have a reduced regulatory burden compared with registered medicines, like Nasodine® Nasal Spray (“Nasodine”). However, as medical devices, their potential to make therapeutic claims is limited by the fact that those claims can only rely on a physical effect (e.g., “traps viruses”) and not a pharmacological effect (e.g., “a broad-spectrum antiviral agent” or “kills viruses”), otherwise they become a “medicine”.
I note that the rebranding of the reference product from “antiviral nasal spray” to now “barrier nasal spray” for their UK relaunch is consistent with its being a medical device and its physical mechanism of action, which as outlined in the release, is: “…forms a physical moisture barrier between viruses and the nasal mucous membrane that traps and blocks virus.”

In Australia, there are already several similar nasal spray ‘devices’ on the market, with a similar barrier mechanism of action and all aimed at the cold and flu market, namely: Vicks First Defence, Mundicare Cold Defence and Blackmores Cold Shield. However, based on independent pharmacy sales data, this category has achieved minimal sales, last year (MAT August 2021) under $1 million in total, representing less than 0.4% share of the ‘cold remedies’ category (see Firebrick prospectus, p. 36). In Australia, it would seem that any new medical device nasal spray would be entering a very small and crowded market.

As to the claims such a product could make, you should be aware that any claims relating to COVID-19 are prohibited in Australia, and any therapeutic claims (treatment or prevention of a disease) have to be supported by human clinical trials. For example, if a product is claimed to treat the common cold or “influenza A&B” then well-controlled human safety and efficacy studies are needed in people with the disease. In vitro efficacy data alone is nowhere near enough to support therapeutic claims and any company making such claims based only on in vitro data would find itself in trouble with the regulators and likely its competitors.

Nasodine is not a medical device; Nasodine is seeking approval as a registered medicine for the treatment of the common cold and as such, is required by the regulatory authorities, prior to approval, to prove its safety and efficacy in well-controlled human clinical studies. Nasodine has completed Phase 1, 2 and 3 human clinical trials and we are currently undertaking a second Phase 3 trial to confirm the efficacy of the medicine in the common cold. If approved, Nasodine will be the world’s first approved nasal spray medicine that targets the viral cause of the common cold. This will be a breakthrough.

In the meantime, we are not concerned about another medical device nasal spray entering the market; also, our “kitty” is very healthy, with no plans for a capital raising.