The FDA doesn't have any disqualifications of repurposing a drug simply because it was approved under orphan drug designation...because they require the applicant to run a separate Phase 3 trial to prove its efficacy (and safety) with patients that are suffering from the disease they are requesting approval for.
Hope that makes sense.
Although I have done a lot of DD, I should also add that all of my comments are my own opinion and should not be used to buy or sell stock of AVXL or any other symbol.
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