FNN Presentation .. WOW!, page-103

Erie2011, don’t get me wrong on that.
I have no doubt our device is far more superior than what are available on the market. When I said Breakthrough program is not relevant at this stage because we are already in the box seat in commencing FIH trial soon. Focusing on getting the trial done quickly and safely with positive data over our competitors will ensure we can obtain the approval to sell the product in US sooner than later.

Yes, Breakthrough status could accelerate the pre-market approval due to prioritised engagement status with FDA, but it could also lead to more stringent requirements on us to prove the distinctive benefits of our product over the incumbents, which may prolong the approval process.

My second thought about Breakthrough designation is that it may elevate our distinctive benefits to the TAVR community which may lead to better sales and adoption, so it may also worth consider pursuing.

Anyway my main point for discussion was about going in alone with partner or selling the company to one of the majors. Risk on execution, funding required, potential returns for shareholders etc...