AVR (ASX) Ann: Quarterly Activities/Appendix 4C Cash Flow Report

Originally posted by synaphai: ↑

Timelines are a huge part of the money projections. Obviously we're still waiting for the start of the EFS to be announced. I emailed Anteris yesterday asking for an update so maybe I'll get an answer but they'll probably just say that I have to wait until info is publicly released.

Wayne has said he expects the EFS to be completed with data ready for presentation by the end of the year but as the year gets longer in the tooth with no EFS commencement, Q1 2023 is probably more likely, although it's really hard to say because we don't know the duration of the study yet.

Then, after the EFS is done and data is presented to the FDA, Anteris will probably have some back and forth with the FDA about the design of the pivotal trial before the FDA gives the green light and the trial commences. Next obviously comes enrollment and doctors doing the TAVR procedures. My guess is that we'll need enrollment in the hundreds, probably 500 or more (because many will likely not complete the trial for whatever reasons), so that's a lot of patients to find and having enough medical facilities involved in the trial will be a big factor in how long it takes to reach full enrollment. The Medtronic trial had 45 locations and the Edwards had 57, so even half of that is a lot of medical facilities to sign up.

Right now we don't know what the duration of the pivotal trial will be. From Wayne's comments, my guess is that he's expecting to follow patients for one year after each TAVR procedures is done but it could be longer. The Medtronic pivotal trial followed patients for 1 year for the primary endpoint and 2 years for the secondary endpoints and the Edwards for 2 years for all endpoints. The FDA will have input into the study duration and there's no point in running a trial that doesn't meet their expectations as far as trial length.

Then, when the trial is done, the data has to be processed and presented along with manufacturing quality assurances in a form that suits the FDA, which takes longer than it sounds for data gathered from a large group of patients.

Finally, after everything is submitted the FDA has 180 days to make a determination.

My guess is best case scenario time-wise would be the pivotal trial starting a year from now with enrollment taking 9 months so the trial would be done in April 2024 and Premarket Approval being granted by the FDA in early 2025, but it will probably take longer than that and could take an extra year if the FDA wants a 2 year trial duration. So sometime between early 2025 and maybe Q3 2026 for approval is my guess.

Wayne also talked about having Dr Meuris in Belgium (who did our SAVR trial) also do a trial to get our CE Mark in the EU, so maybe that could be done in parallel and completed earlier but I have no idea how far along we are with that, or if anything has happened beyond the planning stage. I also asked Anteris about that in my email yesterday.

Expand

Comparing what Anteris will have to do with what Medtronic and Edwards had to do is folly. They are not comparable. When Edwards did their first trials in the USA they had to stop due to high deaths and change the delivery method. It was far from a proven technology.

Fast forward more than 10 years and TAVR is not experimental anymore. Further to this the main component of the DurAVR has already been implanted in 20k patients and Adapt is already FDA approved.

Add to that the prospects of us getting Breakthrough Device and the perks that come to that and we could have an accelerated pathway to commercialisation.

So again trying to gauge what we may need to do in terms of patient numbers etc comparing us to the trials of Edwards and Medtronics may not be accurate.

Just IMO, Not advice and DYOR.

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Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-60

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