The PPS sucks and is at a 3 year low because Amarin is impossible to value as an asset without NCE decision....period.
The current Market cap is based on 2014 "lowest" sales estimates.
John Fuson, former Associate Chief Counsel at the FDA as late as May 2012, was the partner from Crowell & Moring LLP that filed the citizen petition requesting an active ingredient change in the OB. That right, an ex FDA employee privy to confidential FDA material was hired by ??? to further delay a NCE decision.
This petition was filed two weeks before MAPP policy 5021.1.
MAPP 5021.00, "Naming of Drug Products Containing Salt Drug Substances" was posted and effective 2-20-2013. Referring to page 7 and the Active Moiety definition reference 17 at the bottom of page 7. "The USP has announced plans to revise the USP Salt Policy definition of an active moiety so that it will no longer include 'esters'." How lucky was that? Or did he get a tip?
MAPP 5021.11 appears to be directly relevant to Vascepa's exclusivity.
How much access did Mr. Fuson have of these matters before May 2012?
It looks suspicious that Crowell & Moring filed their citizen petition two weeks before MAPP 5021.11 was posted.
How much does Crowell & Moring know about the inside FDA discussions related to Vascepa exclusivity?
Has this petition delayed Vascepa exclusivity decision?
The stock price and options have been manipulate every FDA OB update. An intentional delay could be seen as Securities Manipulation.
The FDA can delay a 505b2 application at the request of a citizen petition if it believes a patient safety issue is involved.
No one at the FDA will discuss this. Crowell & Moring and whoever hires them, is privy to more information than the FDA has released.
Please contact the FDA and complain.
