Omthera and AZN have likely just been slapped with an Antitrust lawsuit. The dots are connectable....if AZN gets a conviction for Antitrust on top of other past violations, I'm pushing maximum Regulatory Sentences, including 10 year US marketing ban. It's time to breakup the "legal" drug cartel...getting dangerous drugs like Vioxx approved killing thousands and profiting billions for a slap fine. Time to get congressional support!!!
Should put a $10 Billion dollar market cap on our stock...we need some court victory's to get there, the FDA's going to obstruct all the way.
Amarin's legal team doesn't sell Vascepa. There's more to this suit than claimed, Amarin is seeking monetary damages. The only damages I can dream up, are Antitrust violations r/t Fuson petition, FDA regulatory violations related to excepting petition, and conflict of interest violations intermixing CDER, Omthera, and Athrotec. $2 Billion in market damages could provide a suit requesting $6 Billion in damages from Fuson, C&M, Omthera, AZN, FDA and HHS. I expected this action, but not this early....it welcomed...thank you Amarin management!
It got approved as a "thank you" for the cash supply by BP for buying seats at FDA meetings. Perfectly legal stuff here;)$$$
The lawsuit filed last Friday is the tip of the iceberg...if the FDA doesn't wakeup...CDER's gonna get buried. That's a promise!
Go to FDAlawblog and read the story, they have links to the actual suit
On February 27, 2014, we filed a lawsuit against the FDA that challenges FDA’s denial of our request for five-year exclusivity for Vascepa based on our reading of the relevant statute and inconsistency with FDA’s past actions. Our complaint requests that the court vacate FDA’s decision, declare that Vascepa is entitled to the benefits of five-year statutory exclusivity, bar the FDA from accepting any ANDA or similar application for which Vascepa is the reference-listed drug until after the statutory exclusivity period expires, and if necessary, set aside FDA’s premature acceptance of any such application.
NP and Lovaza CP come on the same day ... Hummm...
Original Epanova formula was 60 % FA EPA and 40 % other six omega 3's. Amarin's newest patent's may have blocked this formula with the new 30% DHA / 60% EPA ... It will be posted 3-4-2014. It's my speculation Omthera had to go back to the drawing board to come up with a product that wouldn't infringe on Amarin's IP. I can't really see why they'd redo a trial..same population and placebo.
Amarin has 4 NOA patents related to combo's in the past two weeks. AZN is SOL when it comes to catching Amarin's IP. The FDA might run on bribes, but USPTO is still clean.
Currently Omthera is repeating their Marine study and it's not due until 2015...they may have be forced to reformulate due to Amarin's new IP. May 5 PDUFA is not likely to happen.
I'm not positive but Amarin's new patents and Lovaza Citizen petition rejection, may have forced Omthera to change the formulation. Omthera is now repeating their Marine study, you can search it out on Clinical Trials. This is the study that supports their 505b1 with the PDUFA date of May 5. They'll also have to prove full cardiac safety profile due to the much higher DHA blood levels compared to Lovaza. They likely need a label warning for Afib and if the rate is higher than Lovaza...I doubt it's even approved.
In the past 2 weeks Amarin's had 4 significant NOA.
I understand your line of reasoning... But the FDA has no intension of serving Justice! Do you think they're going to let Amarin in? Fool me once, shame on you, fool me twice, shame on me! Don't forget NCE, and Anchor SPA...the deck is stacked against Amarin.
I agree with the 1% rejection...the a FDA clearly has an ax to grind...but selling for cheap...no way! Amarin has 4 NOA patents that destroy AZN's EPAnova purchase and EPAnova has to redo Marine study with new formula...likely related to Amarin's new patents...
The one thing Amarin has proven to be good at...securing IP.
Refresh my memory of "estimated" interim results. If Icosapent works as good JELIS high trig pop, it will significantly reduce incident numbers by 1/2! The FDA's going to have to make a very supportive REDUCEIT study statement for me to back continued spending. It probably one of the only things management has handled correctly in the past year.
Without Anchor and continuing REDUCE-IT is not financially responsible. If Amarin had other products I'd understand...but no further trust should be placed with SPA or FDA. Amarin's management has disappointed me, yes Placebo needs to be vetted in public.