Monday, April 04, 2016 9:23:18 PM
I too wish Amrn had further appealed and litigated the spa. Am I'm not convinced they would have to go through additional appeals as there is adequate evidence that the highest levels in FDA were party to the decisions and additional reviews would have only wasted time and money.
Having said that I am not convinced that the FDA would try to impact results from RI. The study is too big, the impacts too significant. The fact that Amrn has sued and won twice would give FDA pause. In addition, the people at FDA are changing and the record of mistreatment of Amrn so compelling that any suspicious retaliation would bring investigative media and lawyers out of the woodwork in defense.
Fda's efforts are more likely to be focused on enabling generics and dietary supplements to undermine the Vascepa market.
Amrn should go back to the judge re NCE or acknowledge an agreement. It is perposterous that FDA has not ruled on NCE yet. The epitome of bureacracy and or something worse.
Having said that I am not convinced that the FDA would try to impact results from RI. The study is too big, the impacts too significant. The fact that Amrn has sued and won twice would give FDA pause. In addition, the people at FDA are changing and the record of mistreatment of Amrn so compelling that any suspicious retaliation would bring investigative media and lawyers out of the woodwork in defense.
Fda's efforts are more likely to be focused on enabling generics and dietary supplements to undermine the Vascepa market.
Amrn should go back to the judge re NCE or acknowledge an agreement. It is perposterous that FDA has not ruled on NCE yet. The epitome of bureacracy and or something worse.
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