rumper IMO that would be precisely $OCAT agenda for an FDA declared Orphan Status designation for the RPEs AMD/SMD in the USA. $OCAT mgmt will need to apply for that Orphan status, if they have not yet done so. In my Pharma experience, the Pharma will do so after the efficacy is established in a Pivotal Phase2B. However enough efficacy and definite visual acuity improvement has already been established in the Phase1/2A so that the FDA may already be encouraged by the maintained acuity improvements after 3 to 4 years history along with zero adverse events.
The next official SEC document by $OCAT will be its scheduled annual 10-K expected typically in early Mar 2015.
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