Replies to post #23833 on Amarin Corp Plc (AMRN)

[DeepBreath]

Where have you been? We've exhausted all opinions with this exact issue. Was there relevant "new science"? And if not, how can you question the efficacy. That is what this whole uproar is about.

[ziploc_1]

"clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun ____________________________________________________________ No substantial issue regarding safety or efficacy has as yet been seen. If interim results from Reduce-it showed efficacy issues, that would be different.

[slowmover]

If there is a problem with efficacy fda
would have given a crl directly there's
no need for the rescinding of spa.

[Ajax133]

Nuts: You sound like you must be affiliated with FDA or are
a short. There were no issues with either the changes in
Science, efficacy, or adverse events related to Vascepa. The
Mineral Oil issue was debunked by Dr Iffat Chowdhury the
FDA's expert witness , who testified during the Marine approval
that Mineral Oil does not infact increase LDL. Closed case.
Comparing the Niacin and Fenofibrate trials to Purified EPA
IS COMPARING APPLES TO ORANGES. Both of those trials failed
because of the drop out rate due to the nasty side effects of
both drugs. The Intention to treat analysis, used in both trials
severely penalizes the Drug Cohort because of the close to 30%
drop out rate. It would be nice to read a semi intelligent post
from you with accurate information.

[johnking29]

nutsyprofessor: The problem you are running into in this forum is you are new and the issues, comments, statements you are making are items gone over and over and over many times and all have virtually been put to rest.

Unless you post something new like a new 8-K that just popped up on the Amarin site you are in effect asking or forcing people to explain items that have been discussed.

What you should do if it is possible is go back to October 16th in this forum and go thru all Posts since then.

The frustration you are getting is very experienced posters here are attempting to give you the 30 second synopsis and you are coming back with the same "already shot-down counter-points" addressed many times to the point that no one brings them up or asks anymore.

Not being as Technically proficient as the handful of Pro's on the forum (who truly know what they are saying), I've learned to read what they post and not challenge them.

The only people I can challenge are those who are new. I try to (kindly) steer them straight so they stop running into road blocks...

Hope this helps!