I don’t expect any issues with FDA approval. We have operations...

I don’t expect any issues with FDA approval. We have operations and management based and living in the US. We have an extremely talented Ad Board that have deep connections we the FDA. We have the tissue / biological component of our TAVR used extensively on a daily basis that is already approved and well known the the FDA. The actual mechanical device (TAVR) is also well known to the FDA. Plus we have the prospect of receiving Breakthrough Device Designation. You don’t award that and they “slow down the approval”.

I believe the data will be so compelling that approval should be relatively straight forward although does always seem to take a bit longer than expected.

I think we need to remember the company will always talk a long game and will continue to act and prepare for going alone. With Perceptive on board, their capital injection and the listing on the Nasdaq the likelihood of going it alone has increased immensely.

It will now just come down to at what point a competitor wants to step in and buy us out. Hopefully that is after FDA / EU approval and first sales. There is a small chance first sales could be late 2023 in the EU. CE mark is often a faster approval process than the FDA and we will have Dr Prendergast helping with his extensive connections in the EU.

Everything is lining up very well.