Your reply to genisi is similar to my reply in #msg-34379673. What both of us are saying is that an “FoB” program that does not qualify for an abbreviated regulatory pathways is a non sequitur.
I happen to think the economic and political impetus is sufficient to ensure that some kind of abbreviated regulatory pathway will be established in the US for complex protein drugs.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”