As specifically requested in the Citizen Petition, PDUFA date has been delayed and "Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA". No new PDUFA date was established.
I agree. Excellent news. But now is the time for an even heavier foot on the pedal. Amarin and the EPA initiative need to continue to work toward approval. I am sure that will be the case. The FDA needs to know the wrong that was committed at the adcom and how that needs to be reversed!! But this is good news!!
This is fantastic news!!!!! It shows that all the hard work that you, Kole, the EPA Initiative, and all others put in. This would not have happened without these efforts....My heartiest congratulations and thanks! God Bless.