I understand your point fully and you may be right. However,...

I understand your point fully and you may be right. However, everything has changed and not in a way the FDA expected and so something needs to be done.

We now have the first batch of younger patients from the 2019 TAVR approval for lower risk patients coming through and requiring VIV. The current solutions for VIV (for these younger patients) are no longer satisfactory. I am sure the FDA realises this. These patients are potentially going to die and the current solutions are almost palliative.

Therefore, in my view due to an unforeseen issue (created by the FDA) something has to change.

I also think that some more weight should be given to the fact that the tissue in our valve is already FDA approved and in > 50k patients globally with > 10 years anti calcification success (also in paediatrics - harder to do due to fast growth)

Our valve has also now been successfully in humans for over 3 years since the first SAVR trial in March 2023 (and 21 TAVR patients) and the mechanics of the actual device is well known to the FDA.

So if I was a betting man I would suspect that with 10 successful VIV implantations as part of an EFS may result in some negotiation regarding an earlier path to market for DurAVR as a solution to the very serious and growing issue of failed valves needing VIV.

Of course I could be wrong but this is just my own speculation.

DOYR and Not advice.