Replies to post #23104 on Amarin Corp Plc (AMRN)

[Biobillionair]

DeepBreath,

I'm glad she's hearing it from others, but she's known about this BS for a VERY long time...it's likely she's part of the problem and not the solution...just my opinion.

She "looked" into my complaint about John Fuson filing the CP and assured me there's no conflict of interest, this is absolutely incorrect.

1) John Fuson did not qualify under Regulation 18 U.S. CODE § 207 to file the petition, his employment was still in the year window.

2) His document didn't contain the full disclosure statement, also a Regulatory rule. The Lovaza CP should have contained who paid him.

She didn't look real hard and quiet likely looked the other way.


"I certify that, to my best knowledge and belief: (a) this petition includes all information and views upon which the petition relies; (b) this petition includes representative data and/or information known to the petitioner which are unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any representative data and/or information which are unfavorable to the petition were disclosed to me. I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: _________[in the blank space, provide the date on which such information first became known to such party]. If I received or expect to receive payments, including cash and other forms of consideration, to file this information or its contents, I received or expect to receive those payments from the following persons or organizations: ________ [in the blank space, provide the names of such persons or organizations]. I verify under penalty of perjury that the foregoing is true and correct as of the date of the submission of this petition."

My CP comment:

I'm concerned that outside political/Business sources have influenced CDER into making irrational decisions regarding the entire approval process of Vascepa. On 7-26-2012 Vascepa was approved for very high Triglycerides population >500 mg/dl Marine population but not assigned exclusivity at this time.

In the fall of 2012 private citizens contacted CDER Ombudsman Virginia Behr to express concern that the exclusivity delay negatively effected the Amarin's business plan to negotiate a sale to a larger pharmaceutical company with the structure to successfully market the new drug. However, without a NCE/NME designation for Vascepa, it was impossible to value. To date this decision has yet to be made and continues to damage the Business of Amarin.

My concern continued into the Winter of 2013 with the filing and acceptance of Crowell and Moring LLP Citizen Petition ID: FDA-2013-P-0148-0001. My comments to this petition are available in the "Comment" of this document. Again my concerns where brought to CDER Ombudsman Virginia Behr's attention and followed with an informal meeting of these issues.

In the Spring of 2013 the FDA accepted the sNDA for Vascepa in the Anchor population. Later Amarin informed investors that the "74 day" letter was "clean".

In the summer of 2013 the USPTO addressed CDER in a letter, requesting a very straight forward question that directly related to a Patent Extension request made by Amarin IN THE FALL OF 2012! Again, as the delay in exclusivity made it IMPOSSIBLE to value Vascepa as an asset this further complicated assessing the life market of Vascepa and further DAMAGED Amarin. Days after the USPTO letter requesting CDER's decision, related to exclusivity, an Advisory Committee was scheduled to take place on October 16 2013 to discuss the Anchor SPA sNDA for Vascepa. My concerns of a retaliatory response where communicated to CDER Ombudsman and FDA Ombudsman offices at this time.

The October 16th Advisory Committee speaks for itself, the meeting can be viewed in it's entirety via the FDA Advisory Committee Calendar and meeting material website.

This petition accurately assess the content of the Advisory Committee meeting that took place to "discuss Amarin's sNDA 05 Anchor indication approval". CDER under the protection of regulations allowing them to defame Vascepa to the public members of the Advisory Committee singlehandedly destroyed $1 Billion in Amarin market share from the release of the Advisory Documents to after the trading opened post Ad Com meeting.

The views and the requests of this petition are just, however, further delay of Amarin's sNDA for the Anchor population beyond the PDUFA date will continue the unfairness that has been bestowed upon Amarin. After the October 16 th Ad Com, the FDA continued to expand Vascepa's direct competitor Antara. The Antara expansion refers to the addition of patent use codes U-1447, U-1448 and the approval letter signed on 10-18-2013 by Dr. Eric Coleman. Vascepa's efficacy and saftey profile is far superior to Antara, especially in the Metabolic Syndrome population in which Antara raised LDL-c by >14%, >15% , and >40% in 3 separate studies that are included on the label.

Amarin and Vascepa, without question have been harmed by CDER's inactions and direct actions.

In closing, grant this petitions request to reverse the rescinding of the Anchor SPA before the PDUFA date December 20 th 2013. Further delay or inaction will continue the material harm done to investors, Amarin and most importantly patients that have been kept from Vascepa access.