Abstract

To determine the unique US policy and market access nuances which must be addressed for ex-US biotech companies or startups to enter the US market. The aim of this study is to determine what ex-US biotech startups must understand and focus on within the US market access space to best position new drug launches, given the differences among landscapes. Additionally, this work provides a framework of required issues to explore during early decision-making process in a pre-launch setting.

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