LBL...
I agree with your post..Quote: "And if that’s using a certain dc law firm to grease wheels then do it."
The one place FDA does not want to go...Is back to Federal Court..Amarin has used Covington the top rated legal firm in civil disputes and litigation...Chris Sipes (Covington)...was so superior against the FDA hacks in the NCE..That the federal judge told the FDA Lawyers to listen to Mr.Sipes and he will explain the law to you..FDA has a very tough row to hoe here as Amarin is already an fDA approved drug...And that limits how far FDA can go...Since they have already signed out on safety..
In 2013..Amarin was a little known, little company...Pretty much on its own. Eight years later Amarin and its drug Vascepa is known to virtually the entire Cardiology and diabetic academic community..In 2013 Amarin had not the evidence we have today from the R-I CVOT...In fact that WAS the central issue..Regardless how evil you consider the FDA...The fact was Amarin did have any evidence other than surrogate markers to back up any claim it would reduce CVD event risk in statin patients...These were facts...It is true that FDA did "break the law " or use very devious reasoning to renege on the ANCHOR SPA..The new science claim was just them bullying...But the FDA was correct in its assertion that only completing a scientifically valid CVOT would prove that V would lower CVD event risk...
Now Amarin has completed this CVOT...which shows V does indeed cut CVD significantly...How can FDA not grant the label expansion,,,I believe that is what the medical community will say, What Sipes will say and what the Federal judge will say...And this will be a black eye for FDA that will last for a long time...
I think FDA will not let things get to that stage and will simply grant the sNDA....
":>) JL
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