Daily Share Trades - any manipulation?, page-96

I don't want to sound holier than thou on this matter or demeaning of Anteris investors who've relied predominately on Wayne's statements because I've lost money in the past taking company projections on faith instead of doing thorough research but it's been obvious for years that to get an FDA approval Anteris will need a 1000 patient pivotal trial. That was required of Medtronic and Edwards devices so the DurAVR will be required to follow that path too.

With the pivotal trial not starting until next year, I don't think a 2027 approval is reasonable. I think a year and a half after the first patient is enrolled is the absolute minimum timeframe to get to full enrollment but it will likely take longer. After implantation, patients will be followed for a year so the full trial won't be complete until a year after the final patient is implanted. So that's at least 2 1/2 years after the first patient is enrolled. Then the FDA submission has to be prepared, which will take months although it can be submitted in modules as they are completed to expedite the process. Once the modules are all submitted and acknowledged by the FDA, the FDA has 180 days to decide on an approval (although that time period can be lengthened if the FDA has issues with the manufacturing or something).

So 2 1/2 years or more (probably more) after the first patient is enrolled until trial completion, then 2-4 months to complete FDA submission and 180 days (hopefully less but potentially more) to get an approval.