Ann: Exceptional Results in Second Valve-in-Valve Case, page-15

That's correct and that's my point.

Both in Canada and in the US, compassionate use/special access/expanded access requires a request from a doctor or doctors and the decision to approve that request is generally made on a case-by-case basis (in Canada a month's worth of devices can be approved if there is a legitimate possibility of shipping delays). .

The FDA gets requests for compassionate use from doctors everyday and I'm sure Canadian provincial regulators do as well but those uses, while they can add to the evidence needed to eventually receive an approval, do not allow companies to bypass the formal clinical trials process, which in our case is completing small FIH and EFS studies then a large pivotal trial.