Replies to post #46727 on Amarin Corp Plc (AMRN)

[HDGabor]

JL-

How the NCE transcript was connected to SPA rescission? But never mind ..

NCE: I was who said - since the beginning - that NCE will be granted, since Law is a higher level than Regulation, FDA could not replace ingredient with moiety. Meanwhile, everybody else discussed the moiety determination and the new (indifferent) fixed-dose combination NCE guideline ... I said it well before and w/o the recent transcript ...

SPA: We did not learn trig lowering did not work.. and we did not learn trig lowering do work ... Yes, the idea was to allow Vascepa for mixed dyslipidemia, because it lowered trigs, but did not raise the LDL-C like the other trig drugs did. But it was based on an assumption and not on an evidence. FDA stays within the limits imposed by the congressional scheme with "substantial evidence" request. The SPA wasn't rescinded due to any new substantial evidence (occurring after the start of ANCHOR), it was rescinded due to lack of substantial evidence (substantial scientific issue essential). If you think that trig lowering is a substantial evidence, your diploma should be withdrawn by MIT and Harvard Med School.
Yes, the purpose of running REDUCE-IT was to meet with the requirement of the Act (The effectiveness requirement for drug approval was added to the Federal Food, Drug, and Cosmetic Act (the Act or the FDC Act) in 1962, which included a provision requiring manufacturers of drug products to establish a drug’s effectiveness by "substantial evidence.").

Again, if you do not understand something, beyond your depth it does not mean it is a BS. It means it is over your limit.

[louieblouie]

As a govvie - having to testify countless times in administrative court and a bunch of times before the federal courts in DC, VA and MD - i can truthfully say that more often than not the government attorneys are either entirely out of their element or are often clueless as to the process. Can't tell you how many times I had to prod an attorney on how to cross examine their witness.

Having read the transcripts - I wasn't too impressed with the representation put forward by the government. They didn't have the expertise needed to fight their case and there was a bit too much loosie goosie on their idea of definitions. In my department - with three agencies dealing with the same issue - lexicons are a killer. If we can't all agree on what it is we are dealing with - the judges hammer us.

Not because I am biased as a long - but because the government did not put its best foot forward....and therefore has no solid foundation upon which to argue - I really think the NCE issue will not be in favor of the FDA.