The market needs to know in plain language what the FDA requires...

The market needs to know in plain language what the FDA requires from Anteris to get approval in the United States and what the real timelines are.

I am no means an expert, but for other device companies they seem to have a clear and coherent path to commercialisation with the required details (such as the type of application and the timeframes between each step).

I would assume the animal testing and the EU EFS are totally separate from the Phase 3. It isn't clear to me how they fit into the overall picture, whether there has been an oversight, or it is based on feedback from the FDA. For the Phase 3 I believe the steps are something like this.... (keep in mind I am no expert).

• AVR needs to get approval to start the trial - ie agreement on the protocol
• AVR commences to fully recruit the clinical trial
• Phase 3 trial in progress (minimum 1 year after fully recruited)
• Trial is completed
• Data is compiled and release
• If AVR believes the trial is a success they need to prepare a submission to the FDA
• FDA accepts their submission
• FDA informs AVR of the outcome

In my mind I am trying to calculate how many times they will need to go back to ask for more money. There were "one offs" in the last 4c but the outflow of 22m~ is outrageous. Investments in people and R&D can offer a fantastic return but the consistently SG&A (Admin and Corporate) costs are concerning.

Admin and corporate costs (latest quarter) for other pre or low revenue device companies.

AVR: 3,088
EMV: 406
OIL: 50
IPD: 1,997

Note: I had to purposely included IPD as an example of a poorly run company and then they are limiting their cash bleed to under 10m a quarter.

It seems they really needed to raise 100-150m in one go and cop a huge dilution event to get a cornerstone investor onboard so they could get investors to a point where it is a legitimate takeover target. Ie the money in the bank will get us to approval and beyond.