Pluristem announced they applied for Orphan Drug status 30 August 2012 and announced receipt on 21 February.

Submission:
www.pluristem.com/pluristem-files-for-orphan-drug-status-with-u-s-fda-for-use-of-plx-cells-in-treatment-of-aplastic-anemia

Approval:
www.pluristem.com/pluristem-receives-fda-orphan-drug-status-designation-for-treatment-of-aplastic-anemia/

And this was their SECOND US FDA Orphan Drug submission/approval with the first being in 2011.

www.pluristem.com/pluristems-plx-cells-receive-orphan-drug-status-for-treatment-of-buergers-disease-3/

Further, there was a final ruling by the FDA on 13 June 2013 with respect to Orphan Drugs. The publication consists of typical governmental pull-your-hair-out language. But, you can identify within this that it never is as cut and dry as some will have you think.