I'm not responsible for the pre-market review of drugs. We can certainly get an answer to that question for you.
We do, however, in broad terms, review all drug applications, regardless of whether they've been approved in another country first or if the United States is the first approval. We often take the data that form the basis of approval to a public advisory committee, and that can happen whether the drug has been previously approved in another country and approved in the United States, or whether the first approval is in the United States.
With regard to your specific question, I'm not familiar with the program you're talking about, but I can certainly have my colleagues here look into that, and we can forward an answer to the clerk.