The world-other-than-the-US is a big place. The EU (developed economies) has a bigger population than the US. Korea, Japan also. Then there are large developing nations like Indonesia and India. The US market isn't much of a loss in comparison
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The US regulatory ecosystem is.
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FDA approval is not needed in EU/UK since both have their own stringent regulatory systems. For example Metformin was approved in the UK from 1958 and in the US in 1994. The US took almost 4 decades to catch up with Europe!
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