To my mind it is unambiguously positive. Firstly, they are now dealing with the Neurology department, secondly they have basically submitted what the EMA has approved and said does this work for you ?.
If there was some guidance to give or some areas of concerns from the FDA you would get an in person meeting where they could speak more off the record or provide the required nudges to approch. So to my mind that means the FDA see things as being pretty straightforward at this stage. So I suspect they are either "yes, broadly this works for us" or "No, this does not work for us at all". I strongly lean to the former, while from time to time there can be differences of approach between the EMA and FDA, they tend to see things the same way far more than they seem them differently.
IXC Price at posting:
75.0¢ Sentiment: Buy Disclosure: Held
