MNTA does not appear to be taking the Gad litigation seriously, which suggests that MNTA knows its workaround for measuring molecular weight is non-infringing and the FDA is already on board with the workaround method.
Re: Gad patents and timing of Copaxone ANDA review
…it sounds as if MNTA needs to submit an [ANDA] amendment. the fact management does not think this will be rate-limiting in approval tells me copaxone approval is at the earliest a late 2011 event.
Already done, according to Rick Shea on today’s RBC webcast. Hence, I think your inference vis-à-vis the timing of FDA approval is no longer valid.