by statute the FDA may not allow efficacy studies for an AB rated generic (this was a hot button topic in the recent SNY lawsuit). as you know the clinical immunogenicity studies were justified to determine manufacturing purity. i'm not quite sure what TEVA means when they say they intend to conduct and submit PD study results, but if it is an in vivo study it seems to me it cannot be used to supplement their application if they do intend to get a fully substitutable generic
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