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BB, I think the issue of whether the FDA can use FCA to prosecute for off-label promotion revolves around inclusion of specific language that states the "drug was not in fact FDA-approved or clinically proven to be effective for the off-label use". With this stipulation, there is no false claim to challenge.
Best thing to do now while we wait on promised events is take a nice Summer Vacation, dress up the kids and go Trick or Treating on Halloween, plan on having a fabulous family dinner on Thanksgiving (in October or November depending on your persuasion ;>) and anticipate St. Nick's arrival with the hope that our stockings don't get filled up with Coal.
JMO - L & S
From the Washington Examiner article, Gibbons cautioned that, as of now, the FDA's regulation stays in effect. The 2012 Caronia decision was just in the Second Circuit Court of Appeals and other circuits haven't ruled yet on it. "There is considerable uncertainty as to how sister circuits would rule if faced with the same set of facts," Gibbons wrote in a recent blog post.
A number of these articles covering the 1st Amendment ruling have made reference to limited jurisdiction of Caronia and also Amarin. Do any of our legal experts see any exposure to the company as it promotes Vascepa in other jurisdictions?
Honestly Raf, agree that it seems an easier sell with Anchor approval and Insurance, but if I were Amarin I wouldn't give up PI rights to distribute peer reviewed studies and have truthful discussion under any circumstance. It gives the ability to discuss any of the hundreds of studies Zuman has posted here as opposed to just "hey, we treat high triglycerides". JMO
BTW, sorry to say it but the last time I enjoyed any song out of Neil Young's mouth is back when CSN was CSNY. Again, just one opinion.
Tough to argue with you on your Kowa perspective, I looked at their website and the only reference I found to Vascepa was in a 1 1/2 year old news release. It's the original announcement written by Amarin with barely even a word inserted by Kowa. You'd never suspect they were a marketing partner.
Well no one's heard from Hargrove for a while either.....who knows?
Kiwi, my man, you just can't help yourself can you? Got to love it, LOL!
Is Amarin at risk if it follows the ruling of the US District Court but does so outside the NY, CT, VT jurisdiction? Any legal experts around today?
JL, wonder if you know whether there are ramifications of the ruling being issued only for the New York, Connecticut, Vermont jurisdiction. Does it limit Amarin geographically in any way?
Et vous aussi....and I plan on drinking to that. Cheers!!
I've also been an Amarin acolyte since 2010. Seems I remember you from EPADI, I was forced to extricate myself due to unplanned health problems. Been taking Vascepa since first introduced and it's made a huge difference for me! Here's hoping we have the weekend we deserve!
FYI gg, you haven't noticed but Whalatane and KIWI are one and the same. He doesn't keep that a secret. Also thanks to you gg for all of your efforts on this board!
You couldn't ask for a more opportune entry point. It will probably trade below $2.50 for the rest of the day partially due to larger than usual open interest in Aug 2.50 Call that expires today. That could set the stage for a much awaited lift-off next week. Fingers crossed!
gg, I think you're forgetting about the lemons.
To be honest, I'm a little bitter. There should be some movement in this stock but there is none. A company called Aquinox Pharmaceuticals today announced 2 failed or marginal trials and 1 with positive results in its secondary endpoints consisting of a 2 point pain improvement on a scale of 1 to 11 for BPS/IC (bladder pain syndrome/interstitial cystitis) in women. On that news, it is up 528% at 11.25 from 1.79.
And then we have Amarin, which never seems to win. Maybe BB is right and there is no recovery down the road, nobody gives a shit. Anyone want to bet we finish the day unchanged?
I am Short 100 Aug 7 Calls, Long 200 Aug 14 Calls, Long 100 Aug 21 Calls with 2.50 Strikes. Also Long 200 Sep 18 Calls with 3.00 Strike.
Not much enthusiasm from Amrin Mgmt this time on early Reduce-It results. Actually pretty somber unless I'm misreading, looks like no significant results until end of trial! That sucks. Waiting now for the conference call.
Kiwi, I am LMAO over this....you (and I) are having way too much fun!!! What if nothing happens until Q1 2017? Our street cred will be lost forever...we'll be cast as the boneheads of the board!!
I would consider joining you.....but then I'd decide not to do it. Interim occurs late 4th quarter 2015.
Ray - presumably you meant $3 to $4 Billion?
IMO, the only development at this point that could vindicate Dipsy and Doodle (Hargrove and Bertner) is Titan involvement with the J&J/Google JV. Anything less just won't begin to explain their superfluous roles in this company!
BB, is this a new filing originating from Teva? Not real familiar with court proceedings but this looks substantial!
Some might intone "The Three Blind Mice"! There really is no way to make everyone happy...ever. LOL
I would like to avidly second that thought Mrmainstreet....let's move forward!
I wouldn't exactly call the new stock registration "secure funding". You do realize that this is at best a "market" offering and at worst the price could be deeply discounted. There has to be a contra party who is willing to purchase i.e. there could be no takers!
I'm not saying the shelf-registration is a bad thing, it gives the company flexibility to move quickly to seize an opportunity.....if presented.
This is GREAT but the CCI is the Competition Commission of India. We need the FTC in the USA to stamp this agreement between J&J and Google.
IMO, they are all mistaken about the effectiveness of statins. The Cardiologists have decided that their ability to lower LDL-C produces the beneficial action for the patient. Lowering LDL-C is just coincidental to their true benefit which is their impact on controlling inflammation. That is what causes the CVD improvement and AZN knew this when they designed the Crestor Trial. Unless the PCSK9s have that same ability, they will be very successful at lowering LDL-C but they will fail where it matters, in improving CVD outcomes. Fortunately for posters on this board, none of that matters....enter Vascepa! The rest will learn soon enough.
KB, the name of the Cardiovascular Outcomes Trial sponsored by Amarin is REDUCE-IT and it is still ongoing. If the trial had already been completed sometime in the past, then it might be referred to as Reduced-IT.
BB, the first sentence in your complaint should state an "unfair market disadvantage" for Amarin OR an "unfair market advantage for AZN".
So it looks like the FDA managed to delay the marketing of Vascepa to the larger (high triglyceride) indication long enough for AZN to get a new version of Epanova patented that can compete effectively (perhaps more than that) with Vascepa. It will be interesting to see exactly how overt the FDA actions toward AZN will be from this point onward. As for me, I am completely disgusted.
Did you get a chance to look over the new EPANOVA Patent that BB posted?
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=9050309&OS=9050309&RS=9050309
I'm going to go back and spend more time on it, but the cursory review kind of scares the crap out of me. I say this because it appears the FDA is breaking with the norm and perhaps working to fast track approval of this new improved formulation. After all, that's what the Congress is insisting that the FDA work harder to do, get beneficial drugs to market sooner. Wouldn't that be a kick ???, 1st Amendment or not, FDA assists AZN to beat us to the market with Statin add-on for CVE benefit?
This looks like they started with Lovaza and goosed it with DPA and a Urea compound to make it more bioavailable with a very low-fat diet. They make the point that this was a problem with Lovaza as it required presence of fats to absorb Omega-3s. How dependent on dietary fat is Vascepa (EPA) absorption?
It sounds as if it was made clear to the Judge that FDA will prosecute Amarin for misbranding if Amarin attempts to initiate any discussion beyond existing labeling, whether "truthful and non-misleading" or not. It also appears that the judge understands that FDA does not believe Caronia provides protection to Amarin from prosecution for misbranding.
JL, were Abrams (et al) effective in convincing the Judge that FDA's outdated science arguments were rubbish? Was the Judge convinced? He certainly seemed to agree with the obvious contradiction of "supportive, but not conclusive" evidence as applied to a DS but not to an Rx. I hope he has the conviction to write a just opinion.
BTW, any way to get access to the transcript?
OK, that is hurting my stomach, can't laugh this hard so early! LOL.
Thanks Hitch, always enjoy reading Dr. Sears, he knows how to keep it simple.
It all depends on how much leeway the Judge's decision provides. If it is too wide, I believe the trigger will come from the FDA to continue the First Case. They will be compelled to mount a case for a judgement that removes the injunction or they must watch their powers fade away. IMO, they will not stand by watching this time as they did with Caronia.....nor will they succeed in removing the injunction.
kenyboy, thanks very much for these insights. Would you mind taking a moment and modifying the spelling of your references to REDUCE-IT? Thanks for that also.
As soon as they all get back from Disneyworld, we should expect to hear something from our Titan Management. And you know, that 20 grand monthly to Bertner is really not a lot of money, but "one word" per month since they got hired would have been enough to construct and publish an informative "sentence" for the shareholders. I don't know..is it really "over the top" to expect that much from them?
Management is taking a well deserved vacation at Disneyworld. After all, they believe they all bring tremendous value to the table (sounds like Trump)! Unfortunately for us shareholders, the value is in their wallets and it's gone when they leave the table...;>]
Ah well, it's the American way....and now, apparently, the Canadian way too! From the One-Percent to the rest of us, "Here's hookin' up your assets!"
It's the link you posted, BB. These agencies operate with no fear of repercussions because they view us as insects, annoying but usually not very dangerous. Hopefully one day, we can deliver a fatal sting.