3D printed heart valves, page-25

@kogarahboy
I don’t know for sure but I would suggest we did the Georgia trial because of the backlog and waiting list with the FDA due to Covid.
In my view this was a master stroke mainly because it got the options over the line which providing much needed funds and confidence to investors. Imagine 2022 if that didn’t occur, it gave us the data to present on the podiums and something for investors to focus on instead of the impending FDA trial approval.
I don’t believe the Georgia trial means anything to the FDA with regards to our upcoming EFS with the FDA but I am hopeful of the ongoing collection of data from the Georgia trial in conjunction with the FDA trial will lead to the BDD.
I am far from certain of the timelines and endpoints of this first 15 patient FDA trial, and that is because in the announcement WP states we will significantly increase the numbers of DurAVR implants during 2023. Now that is only my interpretation that 15 isn’t a significant increase in numbers.
If it wasn’t for that statement I would have thought the trial will run for 2023 before the pivotal trial starts in 2024. The pivotal trial could be up to 2 years as far as I’m aware, so without being fast tracked I’m going with approval end of 2025.
But again I am far from certain.