But Amarex will "take you from concept to approval" - What's an approval? - I haven't seen/heard of any. ...And that BLA appears a dandy example of "what not to do."
But, I'm a victim of "hearsay" SO I'll wait for the litigation to play out (or a back-door deal) and go from there. Shards of information do not a whole picture make.
The Court will make a determination after they sift through more info than we can easily access.