Thursday, October 17, 2013 1:30:24 AM
To whom it may concern,
I am appalled and disheartened that a circus show put on today (Vascepa Adcom) was able to destroy the future of small bio's searching for medicines to solve our nations number 1 and 2 killers. The decision today to not only violate the SPA agreement and set Amarin up for failure has led many to believe that you or the Adcom panelists were on the take. I tend not to believe these conspiracy options but maybe you can help to educate me further.
First, has any other lipid drug surpassed this bar that has been set for Vascepa, such as the Fibrates or Niacin? The bar being Reduce-It being needed to be finished prior to adding a new label to Vascepa.
Second, how can mineral oil become such an important discussion point when that data show clear statistical changes ignoring the mineral oil?
My last question is this, If the drug is safe and has proven efficacy and the company has done all in it's power as Dr. Hiatt stated, why was the goal post moved in regards to the needed outcomes trials? Your belief that "new science" exists is a wrongful comparison considering the information available (Jelis Study) and the drugs used in those studies.
How unfortunate that your decision to breach a contract will probably result in the termination of a much needed scientific look into the outcomes of the Reduce-It Trials and probably result in the bankruptcy of a company that depended on your honesty to provide them the opportunity to continue this testing.
I implore you to look at the safety and efficacy of this drug and realize that although all the answers are currently not available, the rewards far outweigh the risks with Vascepa.
Thank you for your time,
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