looking at this, I see it's all in vitro, and I don't see the embodiments relating to PK and PD, that is, if they are there, I am not recognizing them as such
it's an invention relating to an in vitro bioassay for copaxone. so it covers PD. One argument TEVA makes for the need for trials is that there is no in vitro bioassay for copaxone like there is for lovenox (factor Xa and IIa activity)