@PabloEskyBruh your reasons to hold $AVR are all good ones.

What makes it difficult for me to value this business myself, is that the pivotal trial will run for some years. Although we've seen a step up in cash burn as $AVR prepared for the launch of the trial, I don't have a good understanding of what the remaining investment is to get it to the approval milestone. Certainly, there are several more raisings to come, as I reckon there is several more hundreds of millions to spend.

Secondly, I haven't yet learned enough about the device and the condition to place a reasonable risk range on the outcome of the pivotal trial.

However, ....

Today's initial readout on the one-year clinical outcomes to date look positive. (I'm puzzled by the ASX SP response. What am I missing?)

In particular, the PPM of 1.5% compared with 11.2% to 35.3% for current commercial devices is a very positive, differentiated outcome.

However, it is interesting that the release highlights "no valve-related mortality", whereas the endpoint for the pivotal trials is non-inferiority on "all cause mortality". (Clearly, they can't communicate anything else at this stage because there is no comparator data set for the historical trial.)

$AVR is definitely on my watch list and, more importantly, on my research list because I always invest effort in trying to understand better the therapy areas I am invested in. And this one is new to me, so I don't know nearly enough at the moment.

At this point, I must raise my hand and point out my previous stupid question about whether data would be unblinded in this clinical trial. It was a stupid question, betraying my lack of knowledge in this area because ... you can't unblind something that hasn't been blinded in the first place!

The pivotal trial is a prospective, randomised trial. Which means that in the patient population, the selection of which patient gets which device is what's randomised. Obviously, the trial can't be blinded becase the surgeon and everyone else involved knows what device is being installed.

So, it was an obviously stupid question for me to ask, and the reason to fess up about about my stupidity, is that this does re-raise the original question. And that is, at what rate will the market be updated on the rolling progress of the trial? Because if there are meaningful interim updates, then there could be SP catalysts along the way. Importantly, if there are significant SP "pops" along the trial, then that gives CEO Wayne optionality to time his capital raisings in a way which might be significantly less dilutive than otherwise.

If this device is better than the current incumbents, then $AVR becomes a multi-billion company, for the reasons you've been pointing out to the community for a long time.You won't get any debate from me about that at this stage.

So, a second question is that, given that once early patients start to pass the one-year milestone for the endpoints, it becomes possible to calculate performance versus standard of care. If the product is significantly better, then I wonder if we could get to a point where there becomes a case to finish the trial early. Because if the results on the endpoints are strong enough, then it becomes ethically wrong to withhold the product from all patients. There is plenty of precedent for this in clinical trials.

What are your perspectives on this? Do you think it is worth asking @Strawman to see if Wayne Patterson would pay us a visit at a Strawman meeting?

Disc: Not held but interested

Thanks for the feedback @mikebrisy, and from my point of view — when it comes to money — there are no stupid questions. I certainly didn’t pick up the error, but I did get the gist of what you were after which is “at what points during the PARADIGM trial will the market know which product is doing better?” I still think it’s a very valid question, but I think part of the answer will be that surgeons and the medtech industry will know first, and those industry outsiders in the retail share market like me will get our information from share price movement — at least to some extent.

As to ASX movement today I think we just followed the NASDAQ draw down to about the capital raise price (when it rains it pours, a lot happening at the moment). I also think that the US can be parochial and the only good news that market cares about in the near-term is the FDA IDE, which I’m convinced is soon.

I know my ‘letting the share price inform me’ as a proxy for interim results may sound glib and reckless, but there have been valve acquisitions of companies with less in-road than Anteris has presently to US regulatory approval. The margins for TAVR are lucrative and I think companies like Johnson & Johnson could make riskier bets than acquiring Anteris. I agree with your characterisation of the investment still required. I think we will average $100 million USD a year from here until approval and/or partnership or acquisition. I don’t think the burn will slow, I think each point on the development (1. Pivotal trial 2. Continued Access Revenue 3. PMA 4. Full commercial operations) will require more and more capital outlay the longer we go it alone.

As to the trial not finishing on ethical grounds (ie due to DurAVR being so good), I think that is slim to non-existent unfortunately. My first reason for saying that is that Edwards Sapien is already clinically inferior to Medtronic’s Evolut on available data. The second reason is that I think DurAVR’s main strength (its durability) can’t really be known until say the 10 year endpoint of this trial. TAVR leaflet failures and calcification tend to take years, so clinical proof of that aspect is some years away yet.

I’m not concerned about how the mortality data was framed in the latest clinical data. One of those was a car crash unfortunately. And in these early stages there are some desperate situations with age and comorbidities . Anteris wasn’t getting the insured Americans in their 60s who only had Aortic Stenosis. The data for the pivotal will be gathered 1 for 1 to standard of care and on large enough samples that there will be nil disadvantage to Anteris.

I’d love to see interest in Wayne Paterson doing a Strawman meeting. Personally, I’m happy with his present updates to the market. However, I think I would have more to gain by seeing the Strawman community ask its questions and the answers he might (or might not) have. He is based in Minneapolis so there would be the (not insurmountable) issue of the time difference to consider.

Thanks for your interest!