I am as shocked and dismayed as the rest of you longs and out a lot of money...but I am in no mood to give up..
I did not not learn anything today new about AMRN..I was not impressed with the AdComm panel. Many years ago I became aware that votes can be purchased, coerced, or awarded on the flimsiest of reasons..including ignorance of the facts.
What was missing in the AdComm today was solid information that Vascepa presented significant health risks to those who took it, compelling information that indicated it had or would fail as a CVD-Type2 DM medication, and a comprehensive discussion on the now known pathophysiology of EPA..
Instead we got a bucket full of mineral oil placebo bull served up de novo without any scientific reference as to why the, according to the pharmacopoeia, inert mineral oil, is now a statin blocker..It was AMRN that should have been asking the FDA reviewer where she got that idea from, instead AMRN was put in the docket and ask to prove mineral oil was not a statin killer..
Then came the niacin-fibrates argument that just because these two drugs lowered trigs and did not show outcomes improvements under all conditions..that EPA could not possibly work...Well to begin with both fibrates and niacin raise LDL-C over the statin lowering effect, this I am sure everyone knows could adversely effect outcomes..Vascepa does not..There are too many examples of drugs working in different pathophysiological ways to produce an outwardly similar effect to conclude because one drug does not have the desired effect that another might not.
The FDA and these clinicians maintain an obtuse relationship with their cardiac drugs clinging to the same old crap. LDL-C is not the most accurate predictor of CVD events..Medical science is very convincing when it pins the principal role in the etiology of CVD and DM on inflammation..These statins have existed under the same aegis they claim Vascepa might exhibit...ie they have not not significantly improved outcomes in patients with high LDL-Cs, but no history of heart disease..At least with the statins...we know they don't work (skip the sermon on JUPITER, we know how they "cherry picked that one).
I am not as negative about the ADComm as most of you, because there was nothing substantial...No smoking gun, no eye witnesses..Just some paid informers and a rigged jury..a real Kangaroo Court..The FDA is going to have to ask itself if its willing to flush its integrity down the toilet and renege on a promise they made that lead to the commitment of millions of dollars by AMRN, not just a "small foreign company", but a company with American shareholders, many who know more about EPA than the FDA and the stooges they hired, and invested their hard earned money on the basis of the promise the FDA made...And please do not argue that the panelists made points about safety or effacy that were game changers..If the FDA was going to make the sNDA contingent on the results of ACCORD and AIM-HIGH then they should have declared those conditions, the FDA did'nt because they knew AMRN would not have gone for the deal..no one would have..
I still believe the FDA will review this AdComm and conclude as I did that the panel has not provided any information significant enough to break the SPA agreement...Mineral oil, fibrates and niacin are not enough...regardless how these jokers voted..Meanwhile Amrn need to get to work before Dec and destroy these arguments...It would also be helpful if they researched inflammation..
":>) JL
AMRN should hire me
