GSK IS, repeat IS already Dynavax's partner on 4 different programs; Heplisav just isn't one of those 4 though (yet).
In short, I think that you are correct, and that is also my point. GSK rules the road over in the EU as well, so the road to the finish line (kind of sort of) has to go through the US FDA.
Dynavax would not be better off trying a flanking manuever around the FDA and to the EMEA. Because GSK guards the door there as well.
Win at home first and I would say that they recognition by the FDA would curry favor with the EMEA for "the nod" in Europe. I wouldn't necessarily say that it's a guaranteed shot doing it the other way around; there is not that much of a record of American companies doing it as EMEA first and then FDA anyways.
The road for Heplisav goes through the FDA first or not at all (partnered or otherwise).
And you don't know who the 8000lb gorilla is over in Europe?
If they have the US FDA in their pockets (via a guy like Dr. Daum) wouldn't you suppose that there is a "mirror-counterpart" for the EMEA? I mean, if they are the "darlings" of the FDA, how could they NOT be moreso to their own home-turf agency?
Just for laughs, go and search for Glaxo Smith Kline Worldwide Headquarters and see what answer it returns. It's kind of frightening (the reach of some companies in this modern age); now isn't it?
Midnight Oil wrote in their song "The Dead Heart":
......Mining companies, pastoral companies
Got more right than people
Got more say than people......
Yes, of course this is possible. But the FDA wants to play games, DVAX should as well; how do you issue a CRL to a company when THEY HAVE ALL THE DATA THEY NEED. They could have at a minimum approved it for high risk groups; instead, they put additional human beings at the risk of getting Hep B, and some will get Hep B when Heplsisav could have prevented it; for some people Energix does not work (Diabetes & CKD)