I can certainly comment on the fact that we treat every drug for a rare disease uniquely. We meet with the manufacturer of that drug and we go over what kind of data they have available, what kind of data they are capable of getting, what kind of data may have been generated elsewhere in the world. We negotiate on a case-by-case basis what will be the requirements.
Every drug is different, and even in the rare disease area, you could be dealing with a drug for two or three patients versus one drug for 100 or 200 patients. It may be a very rare disease in Canada, but not as rare in other parts of the world, so there may be data from other types of trials.
I can't say this more earnestly: We treat every, every drug case by case. We agree on and design an approach to that drug with the manufacturer that suits the needs of that patient community and the data they are capable of obtaining. We use conditional approvals. We use priority review. We use reports from other regulators. We use literature information. We take all the information....
We like to refer to it as the totality of the data, but it is unique to each product.
I don't know if Dr. Stewart wants to add to that.