Don't worry about orphan status as my understanding is that it is a gimme once green light is given for trials - 30 day time frame for response.

Aplastic Anemia is already designated as an orphan qualified malady as FDA has already granted orphan status to other companies trying to treat it, but nothing has yet come to market and most trials came to an end.

So when BMSN/REGEN gets green light for trials and submits Orphan Drug status, it will be an automatic approval within 30 days as I understand.