Quote:I agree with an earlier post in that I don't see what the EMA could require in the P3 that the FDA didn't require.
The EMA is typically more stringent than the FDA. Europe in general has higher safety standards for food/drug products than the US. If we get a protocol ironed out with the EMA, it will almost certainly be good enough for the FDA.
That's why all this nonsense about Leo going to Europe because the FDA is giving him a hard time is bunk. The EMA will be the true test.