Date designated 11/02/2015! How do we interpret: Not FDA Approved for Orphan Indication?
If it is granted Orphan, I'm wondering if the other decision is close at hand, so only one announcement to market?
They certainly seem to have had time to get the Orphan decision out to market by yesterday. It's clearly material news. Might be missing something here, perhaps a formal communication process with the FDA?The timing of the Kaminsky video was very strategic in my view.
FDA Grants Orphan Drug Designation, page-4
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