BK, the reason I was questioning this a few weeks ago was because there were at least two other companies(I don't remember them now) that applied for Fast Track status for OM drugs. I wondered why the other companies didn't file for orphan status and just went with FT. Maybe Leo and Menon think even though it is a "long shot", the fallback is Fast Track, so why not take a chance.
I think what CTIX has going for them is the pre-clinicals were SO effective that the FDA will want to push this through, though I wonder if maybe the FDA can grant some of the benefits of orphan status without, say, the 7 year exclusive marketing benefit and maybe drop another one of the benefits.