I really don't think there's any chance we'll get approval in 2023.
We'll still need a pivotal trial with a larger patient population that will start after the EFS is completed. The question is how many patients the pivotal trial will need. The EFS should be around 15 patients (not sure yet how long they will be followed) but for a comparison, Edwards next gen Sapien X4 is enrolling 915 patients for its pivotal trial and will be following patients for a year. A trial that size should take 6 months to a year to enroll. Then the Premarket Approval application will have to be submitted to the FDA and the FDA will have 180 days to make the decision on an approval. The timeline could shorten a bit if we are granted Breakthrough Device status by the FDA but that only covers our interactions with the FDA, not the time the actual trials take.
I don't see how we could get an FDA approval until well into 2025 at the earliest. A European approval could be quicker but we'd still have to start a trial there. Wayne has mentioned Dr Meuris in Belgium, who did our SAVR trial, but there has been no updated info given on whether that's still in the plans.
Add to My Watchlist
What is My Watchlist?
