" How do we interpret: Not FDA Approved for Orphan Indication?"
All good. We got it for fragile X, and the fda website says the same.
Interestingly according to the fda site it was designated for Fragile X on 23/10/13 and neu announced it on 30/10/13.
Here's the links:
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=409013
http://www.asx.com.au/asxpdf/20131030/pdf/42kg1xkt8lhs43.pdf
FDA Grants Orphan Drug Designation, page-17
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