I posted this comment to EPA CP also emailed it to Ms. Behr and requested she forward it to the commissioner. People should not be confident the FDA intends to change their minds, the delay is a regulatory requirement and a decision must be communicated in a 30 day window, hence out "before" January timeline.
Something to keep an eye out for, is the treatment AZN gets with 505(b)1 application for Epanova. An Ad Com should be announced in the next few weeks. Remember, the blood levels of DHA are multiples higher than Lovaza...do I expect a full CV safety evaluation for A.Fib;). Now this is a real safety issue worth a CP.
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.
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