The FDA submission will have all the OLE data where the EMA did not. The ABCLEAR 2&3 analysis are AD HOC which weakens them significantly. On the other hand finding an genetic factor that cover 50 to 70% of the population and has a plausible biological process does add some weight to that analysis. That is something the FDA will have to decide.
FDA processing time has been considerably shortened. An NDA should get a decision in 9 months or less.
The FDA may be more amenable to the Bonferroni procedure in interpreting the trial results.
While the primary trial data will remain the same, there are other factors that will be different between the EMA and FDA evaluations. There is only one way to find out and that is to engage with the FDA. The company is doing just that. It's too early to tell whether that leads to an NDA filing or not.
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