The narrative around FDA approval is at best confusing. It's now pretty clear that 2026 is the soonest they can hit approvals, assuming they undertake the further studies. They've not said anything about the timing of those further studies and have instead misdirected everyone to the compounding market which doesn't really answer the important questions about approval of the actual product.
Moreover, they don't seem to have progressed with even the TGA - and again, 2026 seems to be the best possible timeline.
So the two key regulatory approvals, TGA and FDA are really no closer and it seems if anything they are further into the future with a requirement for particular clinical trials that were not referred to previously.
Given the share price has been under heavy pressure, perhaps some market participants know this and other did not.
The fact that everything is dressed up means I have zero confidence in these guys going forward.
I think either plan to hold this until 2026/2027 - assuming the cashflow gets there or sell out now to someone who is willing to do that.
LTP Price at posting:
43.5¢ Sentiment: Hold Disclosure: Held
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