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At what point in a product's life cycle would you find it appropriate to submit the same and/or similar registration dossier to Health Authorities ex-US? Are there any gating factors you can think of? What would be the "priority" list of the global expansion?

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At what point in a product's life cycle would you find it appropriate to submit the same and/or similar registration dossier to Health Authorities ex-US? Are there any gating factors you can think of? What would be the "priority" list of the global expansion?