The only (very distantly) similar Aussie bio-tech stock at that stage (post phase III, pre-commercial would be Mesoblast that I can think of. A very arduous journey at the FDA, but finally approved post phase III trials and on the verge of US revenues via its BLA success. Very different before I am bashed for comparing a $2 billion mkt cap company (that you will find me chirping about loading up on at <$0.30 last year on HC against the dooms-dayers there too) in being a cellular treatment of course.
There are quite a few other 510K route approved but less analogous. Neuren Pharmaceuticals (ASX: NEU):In 2023, Neuren's partner, Acadia Pharmaceuticals, received FDA approval for DAYBUE (trofinetide) for the treatment of Rett syndrome, but are in revenue mode. Bit rich on mkt cap for my liking - I do like a bit of contrarian buying of crushed stocks that exuberance ran too early on, but yet may achieve their promise, hence you will find me finding with a number of posters on Hot Copper over the years on different stocks that then bounced from their punished lows.
Botanix Pharmaceuticals (ASX:BOT), Neuren Pharmaceuticals (ASX:NEU), and Dimerix (ASXXB) the most obvious comparisons. If you don't mind 510K, Avita, Polynovo and Orthocell perhaps, all three of which I have owned and the latter two I do now.
RCE Price at posting:
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XB) the most obvious comparisons. If you don't mind 510K, Avita, Polynovo and Orthocell perhaps, all three of which I have owned and the latter two I do now.
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