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Rawnoc, so nice to hear from you! Just keep in mind that it was a 1% advance for AMRN today! Enjoy your weekend!
Oh and one last thing just so you believe I'm paying attention, it's Kool-Aid (you'd think it would be -Ade, like in Lemonade.....odd.)
P.S. I'd love to hear something about the latest prescription numbers!
Ajax, not sure what kind of response you're looking for. I heard you on the BioWorld article, and I believe they (the industry) might provide some support. Unfortunately, I don't have any cash left for meaningful share count so I bought 200 more Jan Calls and (just for shits and giggles), 200 more Dec Calls. Also, I still remember how to cross my fingers, how to bend over and how to kiss my ass goodbye! Have a good weekend, y'all.
So have you come to the conclusion that we should all just sell out?
Dancing, if FDA does in fact deny the Anchor sNDA, you bet your ass the company, Amarin, will have been harmed!! Come on into the light brother!
gta, what did you conclude from the FDA protocol that you were studying, for the agency to change or recall an sNDA? They obviously didn't follow their own process so what do you believe may be options for AMRN?
Hmmm, starts to look interesting! So now I see what BioBill has been up to with his posts. This a-hole, Dr. Coleman, eventually conceded for the record that Vascepa was safe so that should not be an issue. For the FDA to argue new science, they should have followed a specific protocol:
Quote
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A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun (section 505(b)(4)(C) of the Act). If the director of the review division makes such a determination, (1) the determination should be documented in writing for the administrative record and should be provided to the sponsor, and (2) the sponsor should be given an opportunity for a meeting at which the review division director will discuss the scientific issue involved (section 505(b)(4)(D) of the Act).
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1) No such determination appears to be documented nor was such provided to sponsor
2) No meeting opportunity was provided to Amarin to discuss the scientific issue involved
The protocol wasn't followed so either the FDA is not going to kill the existing sNDA based on new science meaning sNDA should be approved -or- the FDA did not follow its own protocol thereby creating an obvious opportunity for Amarin to initiate legal proceeding.
BioBill, you are one cagey and clever guy, but isn't the legal course still a significant risk?
BioBill I really enjoy your posts and am always impressed with your DD. What exactly do you think the FDA will do, just approve the indication as is? I hope that's true but I don't get how you draw that conclusion. What's the mandate?
You talking about Gas Prices, bub, 'cause I think you'll be waiting a long time either way. Amarin, like Gas, will not sell for $1.50 in the near future.....take that to the Bank!
I'm in the same camp as you, Chab. My post was a response to JohnKing and his post #17771.
I just finished reading all of the news items for Amarin on Yahoo and I am absolutely LIVID !!! There wasn't a single piece that accurately reported what the FDA AdComm did to Amarin yesterday. The result of the voting was an injustice of massive proportion fomented by a group of "so-called" professionals who demonstrated an inexcusable misunderstanding of the underlying science and benefits of using Vascepa.
But every one of these articles alluded to Amarin continuing the Reduce-It Trial as a moral obligation. Really? They actually have the cojones to put that on Amarin after the FDA's absolutely immoral debacle with that ridiculous AdComm.
I don't see why we as investors nor the company as an injured party should feel an obligation to do anything but attempt to survive! If that means playing hardball on Reduce-It, so be it. If we can put together a position document to present as Citizen Advocates, great! If we could conjure a way to make some of the FDA bozos and Panel Members look like bigger fools than they already do, fantastic.
But the company needs to get priorities straight right now! The company needs to start revealing to investors what moves it plans on making....now and going forward. Enough with the BS information blackouts to keep our competitors in the dark! Had management paid more attention to the knowledge base on this MB, we wouldn't be dealing with this shitstorm now!
I'm not a big proponent of lawsuits, especially not with government agencies. In my experience, the only real winners are the lawyers. But if Amarin management plans on running this business as usual, I'm going to be getting on the bandwagon with Humphrey, Dumphrey and Moe, LLC, and joining in a Class Action. Amarin might have been setup by the FDA, but THERE IS NO EXCUSE for the lack of preparation going into this AdComm....and that failure has cost us dearly.
The whole point of taking Vascepa is to improve cardiac outcomes in a patient population. However, the proposed indication that should have been reviewed by the panel was as follows:
Vascepa (icosapent ethyl) is indicated as an adjunct to diet and exercise and in combination with a statin to reduce triglyceride TG, non-HDL-C, ApoB, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent.
Nothing in there about Vascepa improving CVD for the indication currently under review. The references to CHD are used merely in description of the patient population being studied.
AMRN had no language re: lowering CVD events in there sNDA application for Anchor.
Linhdtu, my friend, I'm not suggesting a lawsuit against FDA.....more of a Citizen's uprising to protest the results of this AdCom.....and to put some teeth in it, the threat of discontinuing Reduce-It NOW, IMMEDIATELY (or right after a NO vote on Anchor Indication). If the FDA wants Outcomes results, talk to someone who gives a shit.....we need to save what's left of our little "minnow".
Well, I'll tell you what.....I am still giving management the benefit of the doubt. But it's time to step up to the plate with an agenda that benefits us....not BP and not the FDA!!!!!
Enough with the nice-nice BS....pull out all the stops and kick some FDA ASS!!! JL is onboard and I'll bet other pros on this board will be also. We need to start playing the same kind of hardball and if that means shit-canning Reduce-It, then good riddance!!
This has cost me over 200 big ones, my decision, no one else to blame.....if the playing field was level!! It hasn't been and now I want to watch them shrivel. Time to fight back with any and all tools available!!
Thank you and keep on Dancin'...!!
Absolutely....if Amarin takes a position to deal with the FDA decision and try to get by, then I'm calling those ambulance chaser lawyers to join the (class action) suit! That would prove to me that management is not only inept but CORRUPT as well! Let's get to it!
Ajax, God Bless You but you are freaking delusional!!!
You know it brother....now you're talking. What's wrong with maximizing the opportunity for Vascepa? Screw the Reduce-It Trial....if the FDA wants it, talk to the NIH....let them fund it!!!
Amarin needs to sell what they have! Loosen the tongues like the rest of BP and sell the shit out of VASCEPA anyway you can. Crank up the rumor mill with all the benefits and let'er rip!!!
I said it earlier today Ajax, not because I wished it to be but because it was......AMARIN fucked up.....period!! You told me I was wrong, I wasn't and believe me I'm sorry it went the wrong way. You need to lose the altruism brother, it doesn't apply here!
It feels like something is definitely wrong.....BP is in the mix. Amarin lawyers should know about previously rejected sNda agreements but somehow, they don't. There is much here still to be discovered, the lawyers need to get to Washington.....immediately.
The brain trust on this board needs to start writing....not constrained by the FDA. Tell the whole story as it's been developing over the last months. Send the data to the AdComm participants...to the FDA. Cut a deal....force the issue.
If all else fails, go back to the Reduce-It Trial and blow it off. Shut it down at the end of 2013 and work the results for all they can get. If they can't show positive outcomes by then, well who gives a shit anyway, it's a lost cause. You got that prick Cruz playing hardball in the Senate, let's follow his lead!!
There is no way in Hell that JZ will do what you hypothesize! They suck at self promotion anyway, who could he impress now? Unfortunately they just need to move forward as best they can, there are no other real options.
THIS ONE IS ON AMRN!! The Q & A was atrocious, they allowed doubt to seep into the panel.
Gotcha' the 1st time.....I want that, believe me!!
This has really not gone well. I was hoping for much more from Amarin but I believe the results are going to hurt.....badly. Praying I'm mistaken...........
Isaeed, the flashing that you mention is a possible symptom of macular degeneration so, as Grant pointed out, waste no time in getting your mother to an Opthalmologist.
Actually, I'm pretty sure you just did! LOL
I know you like to keep your facts straight, Grant, so let me provide one for you.....Amarin has not been in the 20+ PPS range in the last 5 years. Your references to that price with respect to shorting the stock and all the brilliant traders who participated therein is getting more than a little annoying. Try to get at least one of your primary facts straight......just sayin'. (Apologies for the lack of any color palette - yours are so aesthetic).
There is no possibility of Amarin going bankrupt but go ahead and have your fun........Buzz On little bee!
Really good find STS, strong indicator that the rest of the Plan Admins will follow suit! Removal of restrictions is a really key element!
I think you're correct about long-term Lovaza usage. I adhered to a daily 2gm dose for nearly 8 months. My TGs did come down, but perhaps as much from diet changes and abstinence. At the end, I couldn't keep taking it, fish burps and indigestion, major impact on bowel movements. None of this with Vascepa at 4gm daily, thank you!
With enrollment for the Reduce-It Trial at 75%, it's already a huge plus for investors....although in the near term not so fortunate for enrollees. It means that overall cardiac events will really start to accelerate and begin approaching the outcomes limit. That could drag the trial's ending date forward and ultimately, the sooner results are achieved, the better for everyone. The indications on Vascepa expand for the benefit of all cardiac sufferers and as investors, we finally get a good night's sleep!
Right on Grant, now you're talking.....yesireee! Lock the bastards up!! Moe, Ron and all the rest!
Actually I need to say that isn't true Jesse. I did recognize that I'd seen much of this information (albeit in less detailed form) previously. I don't count myself an expert, but had I not spent the amount of time reading your posts and materials (along with others) over the last year, I wouldn't have been prepared to read and comprehend this most recent paper.
There is a lot of crap that people write about you for motives that only they truly know, frankly I don't give a shit about any of that. Because of your efforts to educate all of us, I've gained a much deeper understanding of a science that I barely even knew existed. I'm pleased about that and you have my personal thanks. Keep the faith, brother!
And to the many other Posters who've done the legwork and taken the time to keep us informed and helped to educate us in the process, thank you all for your efforts!
I completely agree with Zum on this Atlas, an absolutely amazing piece of scientific literature! Terrific find on your part! Once I saw your post and read through the paper, I spent the rest of the day trying to put it out there everyway I could think of. If we could get the Cardios and the FDA to read it today, we could skip the rest of the Reduce-It Trial and get on with treating patients with V.....NOW.
I got it Zum, went out and checked the article as well....and it is ironic. But my little chuckle erupted from the serious tone that came out of Jesse in responding to your quip! By now everyone on this board knows how to neutralize AA......unless they're really brain dead...LOL. Have a good day!
Good ta hear from ya Krazy K, and I hope it continues through the Fall into Winter and right back into next Spring!! Here's to ya' pal! GLTA
Not sure but I'm feelin' Zum's question was both facetious and rhetorical.......been a long day out here on the range podners! (Add a little LOL here and say g'night!)
Atlas, this paper should have massive impact on AMRN, great DD......thanks!!
I am not, I picked up on this from the earlier Post by AtlasSnuggled on this board.
VASCEPA Reduces CVD Risk - New Paper Reports
Great Post AtlasSnuggled
An about to be published study in the Journal of Atherosclerosis and Thrombosis states incontravertibly that EPA administration, the primary ingredient in Vascepa, reduces the risk of CVD.
From the Paper: "EPA metabolizes into bio-active PGI3 (prostaglandin-3), It is assumed that similar to PGI2, PGI3 inhibits platelet aggregation, vascular contraction, myocardial ischemic injury and arteriosclerosis and induces neoangiogenesis. Therefore, it is speculated that the CVD risk reduction induced by EPA is also associated with the effects of PGI3 in addition to the numerous effects of EPA itself (such as TG reduction, inflammation inhibition and improvements in plasma membrane fluidity). This hypothesis is confirmed by the following findings: an increased CVD risk was found to be associated with a reduction in the EPA/AA ratio, and the EPA/AA ratio was found to be positively correlated with the (PGI2 + PGI3)/TXA2 (thromboxane A2) ratio. It is important to increase the PGI/TXA ratio in order to reduce the incidence of cardiovascular events.".
That is EXACTLY what VASCEPA DOES !!! And proving that Vascepa causes a reduction in CVD events is what we're looking for from the REDUCE-IT Trial. The results from this study guarantee the results from REDUCE-IT. Less