Indication Second Indication Clause Samples

Indication Second Indication. First dosing of a patient in a Phase II Clinical Trial [***] [***] First dosing of a patient in a Phase III Clinical Trial [***] [***] Health authority acceptance of marketing authorization submission in the US (FDA) [***] Health authority acceptance of marketing authorization submission in EU (EMA, centralized procedure) [***] Health authority acceptance of marketing authorization submission in Japan [***]