Biotech Values

[rjmcanoe]

Peter
# 5 Sameness criteria for Copaxone
Will the FDA likely request preclinical studies to show that mCopaxone has preclinical activity.It is not known exactly how Copaxone works. Since we don't have an easy preclinical marker for Copaxine, If Momenta shows that mCopaxone is identical or have the same sameness in all other ways, why would they have to do pre clinical studies. Perhaps pre-clinical studied would not be required. Did TEVA do preclinical studies on Branded Copaxone. Im sure Momenta could do similiar pre-clinical studies to those done by TEVA.
Bob