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If this isn't an appropriate question (my guess is due to the fact there that I suspect the answer will involve a fair bit about the differences in laws and policies across the countries when it comes to drug aproval) please direct me to a stackexchange website where it would be an appropriate question.

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I don't think questions about legal issues and regulations are a good fit for this site. Those issues need completely different expertise than questions about biology.

I'm not aware of any SE site that deals with such questions, maybe there will be one if a medicine proposal finally manages to get launched.

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