Replies to post #46769 on Amarin Corp Plc (AMRN)

[jessellivermore]

HD...allow me to explain how the SPA worked...

The notion you have:

FDA "needs to be confident that triglyceride lowering will result in cardiovascular risk reduction."

Is not the terms of the SPA. Factual proof by outcomes studies showing that trig lowering will or will not result in CVD is non existent. So prior to the SPA this was a controversial subject. Indeed even if studies did exist that suggested trig lowering was ineffective this would not disqualify Vascepa, because there might be (and are) differences in the way drugs lower trigs.

The intent of the SPA exception was to cover situations where either a new and very serious side effect/adverse reaction occurred after the trial began which would make the drug risk/benefit too high: or new scientific evidence that "proved" EPA added to statins was not going to lower CVD risk, by trig lowering or other means. Neither of these two crucial conditions was met.

Unstated in the SPA was the fact that in virtually every case imaginable, both the FDA and the sponsor would have agreed to terminate the trial, if a truly significant issue presented itself, because of either patient safety or futility..The fact the FDA wanted the trial..let the trial continue, is certain proof that no such "new significant issue" ever existed..

":>) JL

[Biobillionair]

HD the basic fact you continue to ignore...FDA had no scientific or safety reason to doubt High Trigs & CVD. The studies they used did study High Trigs...the subgroup in the studies they did use with high Trigs showed a reduction. Not only did they not have science they ignored the science they did have. You really need to get this to understand FDA's intent. It was beyond a "mistake"! They got busted, EPADI protested, FDA quelled protest by ILLEGAL CENSORSHIP of 320 citizen petition comments. Most of the comments where in the first two weeks of CP posting...just prior to FDA refusing to turn of rescindment second week in January.

How come you can't grasp this?

BB

[rafunrafun]

So in ACT C) and D), what substantial scientific issue has been identified that didn't exist when SPA was given? I understand that FDA are saying that they are changing their approach and taking a more conservative approach, BUT BASED ON WHAT?? Unless there is a specific issue that caused them to change their approach, this seems like a load of crap whereas FDA is making up nonsense to cover up for their wrongdoings.

[sts66]

FDA expressed to us that the accumulation of the scientific information that led FDA to conclude that HDL cholesterol could not be used as a surrogate end point for cardiovascular risk reduction occurred in the same timeframe as its decision to rescind the ANCHOR SPA agreement.

FDA further muddling the waters in SPA decision by including something that has zero to do with V (again) - WTF do HDL raising drugs (Niacin) have to do with TG lowering drugs (V)? NOTHING.


FDA noted to us that this illustrates that the science related to the use of drug induced changes in lipid parameters as surrogates for cardiovascular risk reduction remains unstable and fluid."

They never indicated this was their belief when they agreed to the ANCHOR SPA - they raised the bar afterward, cannot do that! Hell, if they actually believed that, they not only had the duty to inform AMRN (they didn't), they should never have agreed to a lipid changing drug SPA for ANY drug!