You always make good points and your posts are always...

You always make good points and your posts are always appreciated. I just think you fail to appreciate a few important points:

* The FDA approved the use of TAVR in younger patients and have kind of accelerated this VIV issue. They need to solve it and sooner rather than later.

* You seem to deny any credit AVR may have with the FDA considering the tissue (largest issues in most failures) in the valve is already FDA approved and has + 10 years of excellent use evidence (30k plus patients) in paediatrics globally (most susceptible to calcium due to rapid growth).

* The FDA harmonises with Health Canada on humanitarian use considerations. DurAVR is being approved because there are no viable alternatives. Otter valves may have been considered viable before DurAVR was available because that’s all there was - an average valve or death. The emergence of DurAVR as an option has now rendered the rest of the market no longer viable for VIV (in comparison to what DurAVR can achieve - returning patients back to pre disease state).

* We are a medical device company and not a Biotechnology drug company. Why you compare the two is beyond me as the pathways are completely different and the factors that influence them are completely different. You are smarter than this.

I firmly believe we WILL secure a quicker path to market for VIV than we will for normal AS and first time valve replacement. Wayne has said we will seek a seperate pathway and that VIV DurAVR should be seen as a seperate device with its own market.

So, your prudent pessimism may be accurate but I am way more optimistic that we will get some sort of early approval for VIV use from the FDA.

These patients will likely die a lot earlier otherwise and our results are quite frankly revolutionary and incomparable to anything in the market. It is becoming increasingly unconscionable to use anything else.

This is exactly why a program like HDE exists.

DYOR - Not advice and my uniformed opinion only.