As usual, Helen left many questions unanswered and succeded in muddying the waters. I'm betting that the patents are issued, because she is giving extremely specific expiry dates. Patents are easier to obtain even on a theoretical basis, because the concept doesn't have to be approved for use by other regulatory bodies, e.g. FDA, with different jurisdictions.
As for the requirement for new trials, my gut is that there will be some such requirement but it may be streamlined, since the original product has a demonstrably safe track record. This is not more than a guess though.
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