The Orphan Opportunity: Getting Designated!
Got an idea for a new drug for a wicked rare disease? How do you move your idea from fantasy to pharmacy? More specifically, who are those people at the FDA and how can you best engage with them without losing momentum?
Hear about how to get your entry ticket as an orphan drug from the guy who used to sign them off. Learn about disease subsets, the medical rationale criteria and how do you find those prevalence numbers anyways?
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