While I disdain "all things SA", here's a good read on orphan drug designation and how it relates to overall approval from the FDA. Well written and researched.
http://seekingalpha.com/article/1894751-orpha...hould-care
http://seekingalpha.com/article/1894751-orpha...hould-care
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Lord, help me to be the person that my dogs think I am...