Money changes everything lol.
An announcement around any of these topics would almost certainly light things up. FDA Orphan Drug Act: Fast Track, Breakthrough Therapy, Accelerated Approval and Priority Review.
I believe these items were alluded to in the Orphan Drug Patent announcement 06/11/2013 "USA FDA Grants Orphan Drug Status for PAT-SM6".
ann: data from final cohort of patients, page-39
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