I don't think FDA is stuffing them around. I think IXC are not confident in adding PMD into the trial as an primary endpoint. If they were they would add it in. I'm certain EMA wouldn't object to an additional end point.
The most likely outcome is they roll with the EU trial and have PMD as an exploratory end point and they will then push this to FDA if it has a statistically significant outcome.
IMO, etc
Ann: Notice of Annual General Meeting/Proxy Form, page-112
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