By definition, orphan drug is designated for a small number (relatively). This is why the treatment substitution idea is the key for qualifying. I think what Nader was trying to say when he answered the question from David Callaham, and began quoting from journals was he was listing the various needs Doctors face now for taking patients off of Haart. Once approved, Docs could write it for anyone it might help, but it would be approved as an orphan for treament sub.
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