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Thursday, 08/28/2014 9:04:57 AM

Thursday, August 28, 2014 9:04:57 AM

Post# of 426231
Did the FDA really hang on to Amarin's CP for Two F$cking Months without posting it!

Yes!

Time for me weekly update to my Senator.

CP letter dated June 24th
http://www.regulations.gov/contentStreamer?objectId=0900006481763f62&disposition=attachment&contentType=pdf

Posted 8-26-2014

"So what"... you say...?

Generic filers pay GDUFA fees for Paragraph 4's, they use RLD to see if they can source the generic product, cheap enough to make it worth the play. You can't get pure EPA cheap...unless you run larger batches or have an impure inferior product, that's likely to have an inferior clinical profile and higher side effect ratios, both leading to PPC. (Piss Poor Care)

With the FDA ignoring Amarin's attempts to create an accurate RLD, with the same clinical profile (Ethical Patient Care) they have intensionally ignored their mission and GDUFA goals. They did however collect more GDUFA fees, which is their real intent and (ghost) mission.

Really Really Pissed Today!

I'm calling the FDA Omsbuds & my Senators office and filing formal complaints.

BB

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