Anteris will surely submit the 30 day data to the FDA as soon as...

Anteris will surely submit the 30 day data to the FDA as soon as it's processed and in the correct form so we can move on to the next step of getting the pivotal trial designed and approved. The public presentation of the 30 day data will be in Oct.

Also, after re-watching the end of the talk, Wayne said he hopes to have details at the AGM of a potential early valve-in-valve 2024-25 commercial launch. So it's not definite that we'll get info then. The early VIV approval could be under the Humanitarian Device Exemption, which Wayne has mentioned in the past and covers conditions that affect less than 8,000 patients but with him calling it a commercial launch and saying there was a $2-3 billion opportunity, he may be implying VIV procedures beyond just those possible 8,000 patients per year.

And I do have one note of criticism. I cringe every time Wayne refers to a history of studies showing "zero calcification" of ADAPT tissue. Yes, there are studies that show no calcification on noninvasive diagnostic tests but there are a couple of studies that show calcification in explanted ADAPT tissue [Nordmeyer, Kretzschmar et al. (4/30/2018) and Patukele, Davies et al. (3/13/22)]. I don't write this to disparage ADAPT tissue, but to point out that no medical treatment for serious disease has a 100% cure rate with no complications. Medicine doesn't work like that. If he wants to say "superior anti-calcification technology" like he did at another point in the presentation, that's great. Shout it from the rooftops. But zero calcification is not accurate. All of the other data and info looks fantastic and spot on but that one point bugs me.