DB...
Like your positivity and the fact you are doing something about it. You never know what effort can lead to..You make a lot of good points, but I'm not sure your first fact is correct..IMO the FDA simply rescinded the SPA..not sure they have done anything else besides turning down the company's request for a TypeA meeting, on what they say are procedural grounds..
I am not at all pessimistic about the future of this company. If Amatrins situation was compared to a poker hand, you would conclude they have many outs.
The "scientific issue" the FDA is basing its decision on are:
Lowering trigs in the 200-500mg/dl has little scientific evidence supporting the idea that this will lower CV risk, and that LDL-C is a much better established biomarker for risk. The idea conveyed is that increasing statin doses to optimize LDL-C is preferable to treating trigs.
To bolster this argument the FDA cites three statin add on trials the ACCORD fibrate study, two niacin studies AIM-HIGH, and THRIVE, all of these studies lowered trigs for the most part at low levels, none of these trials made it to conclusion as the they were halted chiefly because of side effects of combing these unpleasant drugs with the unpleasant statins. So ignoring the obvious objection that both niacin and fibrates are very different drugs from EPA, ignoring the fact that the trigs in all of these trials on average in the normal range...What other conclusion could be drawn from these failed trials other than these drugs should not be combined with statins.
A disturbing element in this whole drama is the FDA's selective suppression of scientific knowledge. Understanding there is a large body of clinicians who still embrace the statin LDL-C dogma. There is simply overwhelming evidence that atherosclerosis is an inflammatory disease, and an equally impressive amount (although it's name must be spoken), that LDL-C is not really a very accurate indicator of CV risk, and that lowering LDL-C in primary prevention does not lower CV risk..But this was the debate that did not take place in the AdComm room..Why was Amarin not allowed to introduce population studies showing the EPA/AA ratio in a population is a much better indication of CV risk than the average LDL-C levels..The Japanese have a 71% lower CV risk Americans when age adjusted, yet their LDL-C levels are virtually the same, what is different is the EPA/AA levels in Japan are 70% higher..
I see these facts coming out eventually perhaps in court, perhaps somewhere else. The facts are not going to go away..Amarin is not in deep financial trouble, and I am optimistic about Vascepa sale increasing..The drug is very easy to take..The AHA may have inadvertently lit a fire under the statin issue, by pushing to hard..
In the long haul this is a winning hand..
":>) JL
News 
Market Data 
Discover 
