Ann: US Clinical Trial Results Published, page-53

Distribution agreements in place in seven countries.
Product is certified for sale in all of those markets, and more.
Manufacturing begins within two weeks, distribution beginning within six weeks.

Why do you say 12 months for "meaningful revenues"?

The product already has insane levels of awareness. With the study now published the product now has credibility to go with the awareness. My personal expectation is that we will see significant revenues this quarter, with possible positive cash flows from the December quarter.