mr. vukken99 Im really not a very smart 55 year old.. though.. I been in upper management all my life.. and the key is to be able to evaluate and to draw from those within the team that have insight ..and that's what ive done with amrn. corp.. and individuals as yourself.. you have made the case, as I have dissected this drug to the core,, along with many studies.. ive sat on many panels, spending 100ks and even we were so much involved in securing the outcome.. the fda failed.. and Ive had a hard time understanding why.. with the spa.. the fastracking of this drug that was secured with the spa.. the fda failed without regard towards their written responsibility;;; any insight;; what were the other motives.. im not a conspirator theorist ,,, I just would like truth to be at the forefront.. thanks my good man for your comments.. still believe in the product and the market. long and strong amrn..
Sentiment: Strong Buy
I think Amarin's big weakness has been bringing EPA for FDA approval...they were chasing valuation due to pending or probable mandatory insurance coverage by changing the treatment protocol...
I think this was their biggest mistake here....The biggest market is not insurance based...it is the consumer who are actually looking to spend money on nutritional supplements but they are willing to pay high as long as they are proven to be the BEST....I hear all the time people asking what is the best of this and best of that...and guess what they prefer 10X of buying the best vitamin than spending money on some medication....
Lets look at the scenario of Vascepa being approved the mixed dyslipidemia...
who are the winners: Amarin which will become higher in valuation
losers: Big Pharma now has to pay more to buy out this company and more so they would be force to buy it after this approval because the new market size 10X could not be ignored...
Other losers would be insurance companies now they would be force to cover omega 3 as adjunct to cholesterol treatment in a population size 10X of current statin market...Insurance company will make less due to new cost...
The real losers The American Public...ordinary folks who would not get access to high purity grade EPA.... in reality there is data supporting that EPA use can decrease the incidence of metabolic syndrome so therefore it decreases the cardiac and diabetes and even stroke events....
So if you are bringing to market a medication aka high grade nutrition which can decrease the illness broadly speaking cardiac, diabetes and strokes then think about how much Big Pharma may lose in revenues for less patients needing to take: statins, plavix, xareltos, all those expensive diabetic medications so in a long run big pharma loses big here I think and I did not really immediately think about this...
Sorry that I can be more precise but I am trying to expand the loser and gainers with this decision..
And, it is obvious that in a long run less medicine would be needed for big three diseases...
There is some speculation that EPA or since the advent of Omega 3 class of medications there are less heart attacks than before and even use of statins decreased tremendously.
Once I heard the Chief of Major Hospital stating in the elevator that he stopped taking all statins and his cholesterol became normal with omega 3 only.....so just figure who would be losing in the long run
There was clearly no science in the adcom meeting
look at how wrong they were:
mineral oil use in placebo creating increased abnl lipid number
-ok so did the crestor group in placebo increased the lipid number??
crestor is hydrophilic and it is not affected by mineral oil it should not
because it is hydrophilic so they are wrong on this one
-jelis study; it is good medicine to use lowest dose of statin not high
more chemicals increase the risk of side effects so why are they saying to
use higher dose statin.....i am sure those guys patients are not doing well for sure...
vascepa is already being used with statin broadly and with good response
high triglycerides linked with metabolic syndrome if i am not mistaken
is not the metabolic syndrome high risk cardiac and diabetes as well???
so where is the scoop here??? there was no basis for this except other motives...that is my view of things here
I THINK THOSE WHO SOLD WILL BE SORRY AND THOSE WHO BOUGHT AT THIS LEVELS WILL MAKE A KILLING...THERE IS A HUGE POSSIBILITY THEY MAY APPROVE THIS....CHECK OUT THE PUBMED ARTICLE
A Highly Bioavailable Omega-3 Free Fatty Acid Formulation Improves the Cardiovascular Risk Profile in High-Risk, Statin-Treated Patients With Residual Hypertriglyceridemia (the ESPRIT Trial).
Missing the little detail on CVD outcomes there. You can't get valid CVD data on a 647 person trial over 6 weeks. You need around 8,000 over a few years to draw a statistical CVD change conclusion.
The simple fact is we don't know what impact lowering lipids has on CVD and neither does the FDA. That means the advisory panel erred when they decided the FDA could walk away from the Anchor SPA. The FDA has no proof that lowering lipids does not improve CVD outcomes. Taht means they have no justification to tear up the SPA since there's no safety issue.
This is not over yet by a long shot.