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