Ann: Latest Patient Group Show Best Results to Date at 30 Days, page-83

What he's saying is that we're not like a drug company. With a drug company there can be a lot of uncertainty about whether a drug will pass or fail a clinical trial. The general parameter is the p-value, a statistical determination of the probability that a drug is effective for a patient outcome that is monitored by the trial. If a p-value is below 0.05 then the drug failed. So there's a lot of risk and nervousness waiting for drug trial results as I've experienced many times.

The DurAVR, and medical devices in general, don't have such strict rules about pass or fail and the DurAVR has shown in the patients already implanted that everything looks real good. So that's why Wayne is saying it's de-risked. The DurAVR will eventually be approved it just will take time and money.