One thing that still tickles me is that, why in world would FDA ask for 50 mono patients if they are approving for combo.
Does this translate to ... They already know patients will be using this as mono.... And that's what is stopping them to approve combo before knowing mono is working and safe.
If that is the case why would the company need a trial again for mono..
Is it supposed to be a quick and formal thing.

Any insight/analysis on FDA thoughts are appreciated.