RE:RE:Omnio is all about plasminogeWow Scott! I had missed that "proof of concept efficacy data in patients" part!!!
So yes, we agree: BTD granted first, than pivotal Phase II/III.
Considering the needs (these amputations cost a fortune), I would even shoot for H1 2018. A one year large trial starting in H2 2016, BLA filed in late 2017.
I bet on a quick performance because of Pg P1TD being already approved by then and it's the same freakin Pg! From human. Ultra purified.
:-)
FD