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Monday, September 16, 2013 7:28:05 AM
Vascepa...EPA may be the biggest drug ever. The only other "investor" on this board that may agree with me on this opinion is JL. (Although I hate to put this opinion out there without him actually saying it)...sorry JL;). It's safe to say if the World changed it's AA:EPA ratio it would reduce chronic diseases and save thousands of lives and $Billions of healthcare dollars.
Dr. Sears is no joke:
"A turning point in his research occurred in 1982. That year, the Nobel Prize in Medicine was awarded for discoveries of the role that specialized hormones, known as eicosanoids, play in the development of cardiovascular disease, diabetes, auto-immune diseases, and cancer. Since eicosanoids are only generated from dietary fat, Dr. Sears reasoned that one could apply drug delivery principles to nutrition in order to control these exceptionally powerful hormonal responses with laser-like precision. In essence, this theory treats food as if it were a drug"
http://www.cbn.com/health/naturalhealth/drsears_bio.aspx
So yes, Vascepa, in my opinion, will dawf Lipitor life sales which have exceeded $120 Billion life time sales...so far.
Conspiracy's happen to be my speciality. Many BP's have positioned themselves around Amarin, some legally, some questionable that could go as far as Antitrust violations. At this time I currently believe the FDA is committed to get this right. The NCE delay, Lovaza Citizen Petition delay are proof they are in no hurry to get this wrong...which I take as a good sign.
My absolute worse case senerios:
Vascepa is approve for Anchor (the science of approvability is a no brainer efficasy:safety leaves no other possibility)...but the FDA concludes Vascepa is only due 3 years of NME. NME provides 3 years of exclusivity from the date of approval, December 20 th PDUFA. This gives Amarin 2014, 2015, and 2016...at which point a generic EPA could enter the market...IF they could defeat the OB's patents. In December, if Amarin is given "only 3 NME" the FDA will see the largest number of generic applications ever for a drug...EVER.
This leaves us with the following questions:
Can Amarin protect exclusivity with the 40 patents they likely have booked by December 2013? ( as of today Amarin has 20 patents OB'd for Marine...with the approval of Anchor 11 sitting on the sidelines will go in the OB at Anchor approval). Worse case some slimy attorney finds a way around all the patents...December 2016.
Amarin legally will get a 30 month stay....2017, 2018, 2019.
At worse case...Amarin gets the EPA market until 2019, at which time a Generic could enter after defeating patents. 2014, 2015, 2016, 2017, 2018, 2018. 6 years of solid Anchor marketing and sales.
At bare minimum Amarin is worth $5 Billion worse case.
At best case...Lipitor life time sales >>$100 Billion.
Thanks for sharing your story,
Williams/BioBillion
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