FDA Reviewing Panel Comments In 9-2 Vote
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.
Remember that regardless of these facts, the FDA has clearly said that the failed studies results (featured in recent releases) has changed the atmosphere and tilted the FDA toward (now) requiring REDUCE-IT results before approving ANCHOR indication. This makes all of your points irrelevant.
No it doesn't, the FDA convened an expert panel to ask that question, if it can be shown the panel vote was skewed to get an answer it doesn't really support the FDA won't have any support for that position.
VI. SPECIAL PROTOCOL QUESTION ASSESSMENT AND AGREEMENT 5 If a protocol is reviewed under the process outlined above and agreement with the Agency is reached on design, execution, and analyses and if the results of the trial conducted under the protocol substantiate the hypothesis of the protocol, the Agency agrees that the data from the protocol can be used as part of the primary basis for approval of the product. The fundamental agreement here is that having agreed to the design, execution, and analyses proposed in protocols reviewed under this process, the Agency will not later alter its perspective on the issues of design, execution, or analyses unless public health concerns unrecognized at the time of protocol assessment under this process are evident.
"unless public health concerns unrecognized at the time of protocol assessment under this process are evident" what are the public health concerns with approving Vascepa? None. FDA was referring to some recent studies which showed no benefit of fish oil but that does not raise a public health concern? i think Amarin lawyers should prepare for the battle. they have three months to put their case.
If you watched the panel meeting, everything is clear. There was no conflict between the panel and the FDA. The fact that Amarin already is cutting staff by 50% should indicate they have no doubt about the FDA's decision on December 20th.
I agree. chances of approval are low but are not zero. FDA overturns ADCOM recommendation about 30% of the time but most of these are where the ADCOM says yes and FDA says no. Here, the FDA lead the group to a no vote by the way the worded the discussion question and voting question. So I would say the chances the FDA approves the Anchor label expansion is less than 1 in 10, but is possible. The best hope is that AMRN is able to argue that the failure of the two other trials are not comparable and not sufficient to legally void the SPA. Second, the FDA does want the Reduce-it trial completed and may be swayed if they think it is in jeopardy. No one should be counting on approval, but in my opinion at the current price, CRL is more than priced in. IMHO GLTA