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Friday, January 28, 2022 7:53:20 PM
Yes, that is why they started talking about taking external data before the FDA was publicly, though they likely knew a change in policy was coming because those kinds of conversations with the FDA can often hint that if you wait a bit, we will be updating our guidance or regulation, etc.
But, I'd not expect that the EMA would post the halt in the way they did if it was not driven by the regulator, and they were probably waiting for the explanation when it came up from Feuerstein's article. But subsequently they even said they did not know why, and indicated it was driven by the regulator. And if it was voluntary, they'd not have needed the FDA to "lift" it and it would not still be on the EMA's website with the same status. That would also be true if the FDA imposed it because then the EMA's partial halt would have been effectively lifted when the FDA lifted it and it would reflect that status. It would be the same if the EMA had lifted it and the FDA's status was dependent completely on the EMA's partial halt. B ut the FDA has more discretion since I do not belief the FDA would have imposed a halt of any kind in those circumstances, and only did it because they had to where a relevant sister regulatory body put such a designation on the same trial. Once the trial was complete, because the FDA is regulatory predisposed not to put holds on trials where they are not critically necessary, lifting it was not an issue at that point. As I have said, I think it was a matter of conflicting regulatory directives between the US and Euriope, particularly Germany. This sort of conflict happens all the time in regulated industries. Lifting the halt was a work around by the FDA of the sort we often see with no action letters or other regulatory relief when there are really almost irrational conflicts of policies and rules.
But, I'd not expect that the EMA would post the halt in the way they did if it was not driven by the regulator, and they were probably waiting for the explanation when it came up from Feuerstein's article. But subsequently they even said they did not know why, and indicated it was driven by the regulator. And if it was voluntary, they'd not have needed the FDA to "lift" it and it would not still be on the EMA's website with the same status. That would also be true if the FDA imposed it because then the EMA's partial halt would have been effectively lifted when the FDA lifted it and it would reflect that status. It would be the same if the EMA had lifted it and the FDA's status was dependent completely on the EMA's partial halt. B ut the FDA has more discretion since I do not belief the FDA would have imposed a halt of any kind in those circumstances, and only did it because they had to where a relevant sister regulatory body put such a designation on the same trial. Once the trial was complete, because the FDA is regulatory predisposed not to put holds on trials where they are not critically necessary, lifting it was not an issue at that point. As I have said, I think it was a matter of conflicting regulatory directives between the US and Euriope, particularly Germany. This sort of conflict happens all the time in regulated industries. Lifting the halt was a work around by the FDA of the sort we often see with no action letters or other regulatory relief when there are really almost irrational conflicts of policies and rules.
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