Maybe, and obviously Wayne is trying to generate leverage with...

Maybe, and obviously Wayne is trying to generate leverage with the FDA by doing these compassionate use/special access procedures in Canada but drug companies provide clinical stage drugs to patients for compassionate all the time and no matter the efficacy shown in those patients, the FDA still requires those companies to go stepwise through trial phases to gain approvals.

I can't emphasize enough the fact that there's a reason the FDA requires pivotal studies of around 1000 patients before novel valves can be approved: safety, safety, safety. There are no shortcuts when it comes to validating the safety of life-sustaining devices and trials must have large enough patient populations to prove that the device is safe for widespread use.

Is the Humanitarian Device Exemption for ViV in the US still in play? It's possibly debatable although I've made my opinion known multiple times that there are approved alternatives so I think that door's closed.

This is my projection:

Aug 2024 Pivotal trial start
Feb 2026 Pivotal trial enrollment complete
Feb 2027 Pivotal trial completion
Aug 2027 Premarket Approval submission
Feb 2028 Approval

I'm not trying to be a wet blanket just realistic. I'm definitely not a biotech god so I could be wrong but I think it's a very realistic timeline.

Wayne has talked about going for a CE Mark in Europe, which could be completed faster. I believe he last made those comments at the 2022 AGM but hasn't mentioned anything since that I've heard and running another large trial takes money.