Replies to post #119201 on Biotech Values

[DewDiligence]

BJ et al: The text you are referring to comes from the 2010 Canadian product insert for Copaxone, as written by Teva:

http://www.tevacanadainnovation.ca/downloads/Copaxone_Product_Monograph_EN.pdf

I think investorgold did some random googling and found this hit. Does the material in the above document add anything of consequence to our understanding of what it takes to get FDA approval for generic Copaxone? I don’t think so insofar as similar material has been published and previously posted on this board.

I view it essentially impossible to do a PK/PD study when your pharmacodynamic measure does not take into consideration the "necessary and sufficient" point mentioned above.

Well, MNTA agrees with Peptimmune on this point and says this can indeed be done (and perhaps has been done already). Regards, Dew

[biomaven0]

EAE model in rodents or other species IMO not relevant IMHO

That's a little harsh given the EAE model was what prompted the drug being tried in humans in the first place (if I recall correctly). But maybe you are correct in the current context.

Some sort of biomarker for PK/PD would I think go quite a way to reassure the FDA here.

Peter

[investorgold2002]

you raise interesting questions: question 2 and 3