I appreciate Wayne doing the interview but the problem is always...

I appreciate Wayne doing the interview but the problem is always that the interviewer doesn't ask follow-up questions, likely in this case because he doesn't know enough about the company and specifics of the industry. And Wayne can obviously unleash a verbal onslaught like no other. He's the Eminem of biotech CEO's when it comes to sheer words per minute.

A few things I did notice:

The goal seems to be 100 ViV procedures, which is expected, so those will continue to be done and added to the evidence pile although not in a formal trial, that's what it sounded like to me. I don't expect an early ViV approval but that's just my opinion.

When discussing getting paid for the trial, he said, "if the procedure is covered by (Medicare) insurance". Not sure if that means a $25k USD reimbursement is still undecided but I do think it's probably a good idea to watch the Medicare IDE reimbursement site to see if the study eventually shows up: https://www.cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved

There is the potential to get paid for procedures done after the final trial implant but before approval. This is likely under the Treatment IDE program. Once the final trial patient is implanted it will take another year of follow-up before the trial is complete, then maybe another 9 months to approval with submission and review. In that year and 9 months the company will be able to sell valves for $25k each but those procedures can only be done at sites that participated in the trial.

He said a European approval may come earlier than the FDA but that statement was definitely not definitive so we'll have to see. My guess is that it would only be months earlier, if at all, just because the FDA is slower with the approval review process.

I did chuckle when Wayne said that, "I take a conservative view as I always do."