$ECHOIQ LTD(EIQ.AU)$ I have shared this before but felt a need to revisit this.
Quick update to this "no announcement price movement ". EIQ is pending US FDA Approval for its EchoSolv HF (heart failure). The announcement is imminent, likely anytime soon. They did the filing in Dec last year and expected timeline is 90-120 days, which is around now. The market is pricing favourably for the approval, so if you intend to buy, beware of the risk. As the pathway was using FDA 510(k), this pathway has a historical high approval rate (85-95%). Having said that, it is still a binary event, meaning yes, or no!
What is this EchoSolv (HF) and why is it important?
In fact, the company had a prior FDA approval on EchoSolv AS (Aortic Stenosis) in 2014. The recent agreement and hospitals deployment is attributed to this approval. HF or heart failure is a totally different animal altogether. While Aortic stenosis covers only a single heart disease, heart failure as its name implies, covers the entire heart. It is therefore a game changer as it is very broad. The market size is obviously massive (we are talking about ~$60B here, yes, with a "B")!
Therefore, market has partially prices its success, but the actual approval would still trigger a major analyst's upgrade. It would be transformational and I am looking to hang around a little while.
I repeat, the market is anticipating this imminent FDA announcement, so it's probably high risk to come in now. Importantly, it could still go either way. It has happened before. This is the 2nd submission after FDA came back with more information. Trade with your eyes 👀 open!
Just for any keen... it's AI... and could be a lifesaver with this approval and subsequent deployments... one last thing, do you see a potential double top? Then a correction might be around the corner... however if the price shoots beyond the previous high, then a super uptrend is coming... so it goes either way... the RSI indicator confirms this! It's in a very good uptrend and not overbought at all, so I am optimistic...
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Having gone through the process before, it is likely the market is overweighting a possible positive outcome given prior experience of the approval process.
What comes after around September will be the submission of CAT III, which is the US insurance billing code for smooth processing and payment.