I wouldn't expect it to work exactly as you outline. Each jurisdiction will still have its own guidelines and rules that they use to establish what they will and will not approve. That said, I would expect that they may accept much of the existing data that would have been part of the FDA process. They may then ask for their own version of a Phase 3, perhaps with lower patient numbers. Its their choice, but I definitely would not expect any jurisdiction to just 'rubber stamp' an approval, just because the FDA had already granted approval at some level. As you say though, there is nothing to prevent anybody, with the means, to travel to a country where approval had already been granted. Happy to hear a counter view ... but that's my understanding. Now if it was in Africa ... that may be a whole different story.
AIMO.
IMU Price at posting:
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