>MNTA …the FDA contends that it may not be, or else why require immunogenicity studies.<
The FDA has not yet said they will require immunogenicity studies, although they may do that. All they’ve said so far is that they want more information vis-à-vis immunogenicity from all of the generic-Lovenox applicants (Teva, WPI/Amphastar, and Sandoz/MNTA).
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”