A developing story, the FDA will be closely reviewing discussion comments and questions that arose during a recent Vascepa FDA panel hearing. Actual comments are typically reviewed for FDA decisions on new drug approvals. In fact, they play a critical role and were the factors in recent weight loss drug approvals, in light of negative panel votes. Nearly 25% of panel vote are ignored by FDA (admittedly, more yes than no votes), and in each case, commentary from the panel was used as justification. Commentary from the panel on 10/16 revealed more than the usual doctor insight on the requested indication and medical need - comments at the Vascepa panel suggested clear confusion about what question was being asked and several doctors were also confused about information presented (or not presented) during the FDA's presentation:
-Critical safety data on Vascepa omitted, yet voting question asked about safety and nearly 40 minutes taken up discussion safety
-One doctor asked before voting to clarify and explain the question being voted on
-One doctor asked to re-write the question or answer a different question
-Another doctor goes on to say to the FDA that AMRN has done everything FDA asked them to do
The FDA is a very documentation-driven (black and white) entity and the panel's commentary will clearly not support the 9-2 vote and an outright rejection on the Anchor sNDA. If anything, the FDA and AMRN must work together to come to an agreement on how Anchor gets approval on December 20th with the proper labeling language. In this case, everyone wins - FDA, patients and AMRN investors.
Will keep following the developments, this one is going to be a photo finish.