Replies to post #54660 on Amarin Corp Plc (AMRN)

[Sam81]

I'm having a quick read...point 72 is interesting:" government admits that the anchor study was not designed to measure the impact of vascepa on cardiovascular risk....." WTF, this means that it should have been approved...correct me if I'm wrong pls!!

[jessellivermore]

Thanks HG...

Amarin's response to FDA is 62 pages long. Have skimmed it and will go over before too long..

Looks interesting...For you Game of Thrones junkies...You know nothing FDA.

This is a wowser response going back to the start of the century. Basically the document, which could be squashed if the judge agrees Amarin has no status, or the case is not ripe, is a frontal attack on the FDA's ignorance (I told you so). The FDA simply lacks the medical and scientific evidence to determine what is true or false. They repeatedly, as in their NCE decisions, contradict themselves in terms of their decisions. They are woefully inadequate in general medical knowledge so much so that they make ridiculous decisions which offer zero consistency one to the next.

This response brings upm the SPA (paragraph 62)...It blasts a whole in the ACCORD trial which the FDA had prior characterized as referring only trig reductions by fenofibrates. It brings into play the 2004 decision to allow "supportive, but not conclusive" qualified medical statement to dietary supplements.



Basically the FDA can not attack companies for non truthful information if "They know nothing".

":>) JL

[gozips]

Thanks, HG, for the information. Have only given it a glance, but it appears to be chock full of horse hockey.