Yes and they would have to report the activation of the Shelf!
I am not sure a label change for Vascepa, would be a good reason to delay shelf registration. But you are correct not needed now, but the did file a regisitration, then turned full circle and delayed it. So the next 2 weeks will be interesting.
Question did they say we will have an answer in two weeks? or was this an assumption. I forgot how Amarin worded this FDA appeal delay during the C.C.