I think Amarin could be wrong regarding delayed PDUFA date, this can be clarified and communicated to stakeholders. Woodcock would have to sign off on PDUFA delay and I don’t see this happening....
It’s totally acceptable for the FDA to hold an Ad Com after PDUFA date and “some” label expansion...
Amarin can get this clarified by contacting Dr. Woodcock...hopefully hear something by the end of the day on this......
If Amarin asked the direct question she would provide an answer: