Sure, depends on your drug(s), how many prescriber

Sure, depends on your drug(s), how many prescribers you need to get it to, and very importantly your competition in the space. 89% of the more successful companies in your example for Europe were orphan drug designation. Every situation is different, but me personally and my opinion I think licensing is needed to get out of the gate. We can argue go it alone semantics after we can afford to pay the light bill.