A non-scientist (most of us and the judge) could easily describe the request for immunogenicity data as EITHER relating to bioequivalence or purity. The judge might even be dyslexic on iv vi.
Thus the contributions of mouton* (whose sense of humor I have come to love), Mpower and DD have pegged the decision.
JMO
ij
* Getting us the documents was greatly appreciated.
There are times when rules and precedents cannot be broken; others when they cannot be adhered to with safety. (Thomas Joplin)