CEDAR response to my email. The last sentence sounds somewhat promising...
"Thank you for writing to the members of the CDER Medical Policy Council at the Food and Drug Administration (FDA) regarding FDA’s rescission of Amarin’s Special Protocol Assessment (SPA) for its drug, Vascepa (icosapent ethyl), which is currently under review. Please accept this response from the Division of Drug Information on their behalf.
Your comments have been received and are greatly appreciated. Please know that FDA is making every effort to resolve the matter as expeditiously as possible, while also ensuring that the Agency’s decision reflects a full consideration of the issues brought to our attention in light of all the available scientific evidence."
Best regards,
LC
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration