The most recent investors presentation I have (the one on the...

The most recent investors presentation I have (the one on the website won't download) only has DurAVR milestones through 2020 and the end of year financial report is not exactly packed with details either.

A timeline going forward would be very helpful, what we expect over the next year or so and what boxes need to be checked before we have the clinical evidence to support a premarket approval (PMA) submission to the FDA, which is required for Class 3 medical devices, defined as supporting or sustaining human life. Here is the premarket approval process info from the FDA:

FDA Website Premarket Approval

So we need to still gather data from trials before we submit our PMA application with the FDA.

From what Wayne has said, I believe we still need the greenlight from the FDA for our trial design going forward but I am unclear on the timeline for the trials to possibly be completed.

Once we have supporting evidence and submit our PMA application, it will take time for it to be scrutinized and acted on by the FDA. The most recent stat I can find for how long it takes from submission to approval is from 2015 and is 276 days but the FDA has endeavoured to bring that time down so hopefully it will be shorter, but that's just the final step of the process.