We have a 30-day review period for those packages. Generally, we have a meeting with the manufacturer as well at that time, and point out any considerations we have. I'm talking about the drug side; the exact timeframes I'm more familiar with. Then there's a commitment for the manufacturer to file the submission within a certain time, between the decision that we grant them priority status and when they come in with the package.
Generally, there's no requirement for companies to come in at a certain time after the presubmission meeting. Then we go through the process.