The MDSAP audit is a regular audit. People have annual audits as part of the MDSAP program. For the MDEL, depending on whether you're a manufacturer or an importer and distributor, it will be two- to four-year cycles. You have two cycles going, but when the two coincide, and we're within three months, and you're essentially looking at the same elements that are being audited, there's very little difference. It's more the scope of the product that changes.
On February 7th, 2019. See this statement in context.