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biowreck

04/03/15 7:53 AM

#46627 RE: HDGabor #46625

So HD, are you saying that the Anchor SPA was written and agreed upon by both parties to include vascepa's effectiveness by measurement of reduced CVD? Because I thought reduced CVD was the primary measurement of reduce-it, not Anchor SPA. If the game plan changed, FDA never notified Amarin that I'm aware of....and that is also part of the SPA language...to notify of changes to the agreement.

jessellivermore

04/03/15 4:40 PM

#46727 RE: HDGabor #46625

HD,

IMO: You are far to kind in your treatment of the FDA. You make them sound like the lady's knitting circle down at the local church. Clearly you need to read the NCE transcripts.

The transcript paint a far uglier picture. FDA comes across as high on its own authority. The transcripts reveal a pattern of the FDA ignoring or changing congressional statutes, changing definitions and decisions in a arbitrary an inconsistent manner and making interpretation where the statute does not grant FDA the authority to interpret.

And this does not even get into the possibility that corruption might play a major role in some of the decision making. Hard to come up with other plausible explanations. As a graduate of MIT and Harvard Med School, I do not for a minute believe the FDA's argument in rescinding the SPA holds water and that it would persuade a fourth grader..Just pure unadulterated BS put out by people who think they answer to nobody.

":>) JL