md34...
Quote "What are your thoughts on whether they owe Amarin anything for this mistake and if so, how you think they will “make it up to them"?
These are very good questions and I have spent some time thinking about this..
FDA is a bureaucracy, hierarchical in nature...FDA employs over 15,000 employees so there has to be a good deal of delegation of authority. So what happens when subordinates make mistakes, or in this case when a subordinate makes a colossal blunder and promises or guarantees get reneged because carrying out the promise would lead to unacceptable consequences.
This question goes all the way back to Greek Mythology...In the myth of Phaeton and the Chariot of the Sun...
Please understand there were people (private individuals) on the MBs in early 2013 that said the FDA would not grant the mixed dyslipidemia label without seeing a convincing CVOT (completing RI), Posters like myself thought the FDA would never renege on an SPA simply because it was congressional creature.
So the issue must of come up...Certain BPs would have made certain FDA understood the issues, and how fragile was the proof, if any that EPA, would reduce CVD event risk in this group...And this indeed turned out to be the famous Mary Parks question to the SPA panel..."Considering only the ANCHOR trial results only...How confident are you that Vascepa will lower CVD event risk"...This was a directed question because the ANCHOR trial addressed only blood chemistries and said nothing about the efficacy of the drug...
The FDA made a mistake in offering a label expansion for a drug which no scientific or clinically convincing evidence it worked...
FDA being a bureaucracy did not admit it made a mistake..It did go into CYA mode. It never considered that it owed Amarin anything...because Amarin should have understood the folly of receiving such a windfall not based on solid evidence...
FDA did break their word and like a bully they did use the power of a sovereign agency to stone wall the company and prevent them from seeking remedies in the federal courts...as a shareholder like many others on this board I have been injured like you...
Still I believe the right thing was done...Vascepa needs R-I...If Amarin had been able to force V down the FDA's throat I believe the medical community would have boycotted the drug as the issue of clinical proof would raised over and over again...Better that our proof is beyond the pale...
Patience the time is comming...
":>) JL
