2015-2016 was the original time frame for final Reduce-It results. Of course, that was put asunder when the FDA decided to thwart ANCHOR. John Thero's persistence and ability to find the funding and partnering to make Reduce-It a reality is rather amazing. So, let's consider what the FDA has actually done here. By denying Amarin exclusivity to the high triglyceride market, they almost scuttled a study that could have incredible resonance for millions of people. The FDA "encouraged" AMRN to finish Reduce-It, well thanks, how about some labeling restriction loosening or ability to talk about new studies with doctors, such as the ANCHOR study. But NOOOO, the FDA would have none of it, causing a further delay in the Reduce-It results. Originally, full participation in the Reduce-It study should have happened by the end of 2013 but it still hasn't occurred. Amarin is lawyered up and ready to answer any questions, they have one of the top free speech lawyers too. They'll talk about the more than two decades of study on eicosapentaenoic acid and the safety profile as comparable to placebo, (a profile that is about as close to perfect as any drug can achieve). They'll talk about AIM-HIGH and THRIVE and how Niacin is a different drug completely. They'll talk about how ACCORD and fibrates are quite different things as well. The studies didn't even measure the same things. The court is going to notice.
Oh, that's the prize alright, I agree and it should be a spectacular success. I think though when the FDA mentioned the SPA in their brief then scolded Amarin for not talking to them first and could advertise as a dietary supplement, well, they opened themselves up to a rather well deserved behind kicking. 70,000 souls got their Lovaza fix last week, with some fish burps and afib and higher LDL-C simply because they are grandfathered into acceptance. This judge might go further than we know in rectifying a situation the FDA themselves invited with that infernal letter. This judge might just get medieval on an FDA that's been brutal to Amarin. At least that would be nicer than my approach.
The FDA's decision on NCE took 18 months. Taking that long it seemed an arduous ordeal, full of complexities even doctors and lawyers couldn't begin to contemplate. The FDA was up to the job though, finally finding the exact formula and minutia of arguments that finally explained how Amarin's V drug didn't qualify. THEN, Judge Moss saw through all of that rot almost immediately and was rather taken aback by the FDA's reasoning.
Now I don't about any of you, but to me the ANCHOR SPA and the ADCOM question and the other failed unrelated trials mentioned at the ADCOM plus the mineral oil issue raised at the last minute are far clearer to me than the NCE question. If this judge is anything like the NCE judge, the FDA has already lost huge. I have no idea exactly what that'll mean for the stock price, but I doubt it'll be bad.
Great conversation. The best rebuttals can be Googled at: EPA Drug Initiative. The huge difference now is the FDA isn't in charge of the outcome of the 1st amendment trial. That in itself is quite different and in light of the NCE ruling, the FDA seems incredibly vulnerable here. Note that Amarin took it in the chops with that ADCOM vote. Since then Amarin has asked for some small labeling changes and/or studies that could be conveyed to doctors. What Amarin asked for was quite reasonable, and it light of the SPA and the actual ANCHOR results, the requests were no brainers, yet the FDA "thought really hard for a long time" and then said no each instance. This little company is conducting a $100 million study without the resources to do so. Any little minor compromise with the FDA could have helped this tiny company pay for this game changing study that likely will show benefits for mankind. Instead, Amarin had to dilute and rely on the investment of believers. The FDA, by their actions, almost killed that study and Amarin. The court will notice.
Hi Akanz, hope you're doing well! Thanks for the caution and reality. I'm thinking you realize all this...that ANCHOR was ultimately characterized by the lowering of TG's and more or less neutral effect on LDL-C when ultimately it was much more. The evidence keeps piling on. A natural balance of lipid readings is key, not the amount of reduction EPA almost seems to communicate with the body somehow, always asking, "can these lipids just live in peace?" I don't know how this will all play out, but I certainly didn't expect the FDA would lose that NCE ruling, did you?
When the court tellsthe FDA they royally messed for 18 months and reverses NCE, it should take no more than a week or two to grant the designation. We're beyond that and Swalchie's contact says they'll appeal, he's rarely wrong.
?? PK, you usually have some good points, this isn't one of them. Vascepa has about 2 decades or so of not just a good safety profile, but the best in all of pharma. The effectiveness may be a concern, since everything else has failed. JELIS is the only successful study for this population, so at least with Vascepa you have a best safe chance. What don't you get?
Niaspan and Triplix got their labeling from the FDA prior to outcomes and both became billion dollar sellers, both are far more harmful than Vascepa. Vascepa did everything and more than the FDA required and was shot down because of an ambush at the ADCOM. The two things you can shoot down a drug for, safety and effectiveness, were both not a problem with Vascepa, but the FDA moved the goalposts based on unrelated drugs that have far more side effects. The court is going to see all this and they ain't the FDA.
Works with stations reducing their toxicity and improving outcomes
Patented to the gills
About to get some attention nationallynationally
Good to hear your thoughts. No one truly knows anything at this point except the FDA seems to hate AMRN. Winning the NCE case was strange and after the FDA sent that reg letter I'm certain Amarin s chances to win this have improved. It would be nice, but in any case we wait for Reduce-It.
FDA rapidly losing all their brownie points with the court. The reason for the dull action the last several days is due to the second requested delay by the FDA. It now appears the FDA is following their dogmatic playbook and will be putting Amarin in purgatory again and appeal the NCE decision. On top of that regulatory letter the FDA filed telling Amarin they shoulda done this and coulda done that and get some dietary supplement angles going, this Judge might just explode. Everything's being exposed now and the FDA is showing their true selves to a Judge, not just the officers of a micro cap company. Swalchie thinks AMRN will lose this but the FDA has butchered this so far.
Interesting that he endorses these drugs without outcome studies. I have to admit a high level of excitement with these drugs, but there are some questions. Could PCSK9 contribute to Alzheimer's later in life? I ask that because the drugs affect the cortical neurons to some degree. We also have very little information on what turning "off" genes does long term. Dr. Nissen's enthusiasm for these drugs is a rather strong about face considering he was aghast that ANCHOR was even a thing being considered. I think I might dislike him even more now, and I thought that was impossible.
Scrips are ever important and this company just won the NCE case and have been backed up by 3 friend of the court briefs in this possibly historic 1st amendment case. The sales reps are energized to an extent not seen since before the ANCHOR ADCOM and there's far more of them now. If you don't think that's making a difference, you have not been in the presence of of pharma reps. Scrips are going way higher now.
Amarin spoke with the FDA about all this once, twice, and even three times. Getting Anchor labeling or some kind of consideration on messaging to doctors. The FDA's regulatory response was so horribly miscalculated in response, this case is over before it begins. Amarin is going to win some or all of their requests, and might even end up with the Anchor market exclusively. It's as if the FDA wasn't paying attention and forgot all the crud theyve put AMRN through.
It makes you feel better. It's improves mood, elevates concentration, calms, helps reduce inflammation reliving pain and associated grumpiness. Not only does that improve the experience of life itself, it improves the atmosphere for everyone in the proximity of the Vascepa user. Almost any other drug used to reduce triglycerides or cholesterol is basically either neutral or a detractor for the everyday living experience. Add to that these other drugs have more sinister side effects, while Vascepa is widely thought of as one of the safest drugs on the planet. So, regardless of the results from REDUCE-IT, prescribing V to high triglyceride sufferers would help them enjoy life more now with the added bonus that they're probably improving their heart health dramatically.
The FDA pointed out basically their initial position in that letter today. Amarin is no longer the cowering boy scout they were at the ADCOM, they've been down that road once before. This is a company with profound legal representation. The FDA should have been far more compensatory today, they just put their neck out there, stating what amounts to caveman logic. I thought we might see some glimmer of a true olive branch, but the FDA didn't really budge at all. All the points that AMRN could have made to that biased panel at the ambush of an ADCOM wouldn't have made a dent that day, but unbelievably the same exact arguments have gushed out again, but this time to a judge who will actually understand AMRN's arguments. The reason for that is, they're the truth and quite evident. I take back thinking the FDA would win this thing, they just stepped right into it and they'll know they did right soon. Now that NCE ruling looks quite big.
Been reading with great interest whatever is going on with this 1st amendment argument. Most likely outcome is AMRN loses this case. Of course, AMRN just won a case against the FDA on NCE so perhaps there is some hope, but the FDA can appeal the ruling and almost certainly will. It's very disturbing the way the FDA has acted towards little Amarin. Honestly, the only thing we're talking about here is Niacin, Lovaza and Tricor plus their generics getting easier access to the ANCHOR market than Vascepa. That just sentences some people to more side effects, such as afib and kidney failure, and deny them a very good chance at better outcomes. (THINK ABOUT THAT, THAT'S ALL THE FDA DID WHEN THEY DENIED ANCHOR ). Since the FDA did something so repulsive, I have no doubt that regardless of what you hear on these boards about what "compromise" the FDA is debating it doesn't amount to a hill of beans. The FDA is an extremely powerful and well connected entity that hates Amarin and they will win this case at all costs. By the way, I hope I'm totally wrong.
Triglycerides are important as are many lipids. Unstable angina is a bit different than angina measured in JELIS. Reducing inflammation is the greatest thing Vascepa does and it does it through balancing lipids to an optimum level. The JELIS study used 1.8 grams vs. Reduce-It using 4 grams. They say that balances the effectiveness since the same level of EPA is found in each the Japanese pop with the 1.8 and the rest of the world on the 4 grams. Baloney, that's not accurate. The non-Japanese placebo population in R-IT is missing out on ALL 4 grams of help, while the control group gets a full 4 grams, taking them to the level the Japanese arrive at on 1.8 grams. That's a monstrous big difference and if anything may delay the interim trial endpoint a bit.
The reason why there is no date on REDUCE-IT interim analysis is because it happens based upon "events". Statistics tells us the events necessary to trigger an interim analysis should happen in the first half of 2016. Actually it can happen any time now because the addition of patients into the trial was never revealed completely, so the results could be later or earlier than the first half of 2016.. Regardless of the 1st amendment case, the FDA's response to the NCE decision or the weekly data, REDUCE-IT towers over everything. You've heard about Steve Rosenman claiming the stock would be 20 with ANCHOR approval. He's not talking about REDUCE-IT approval. That's a magnitude far greater. It's not just that there is a total of 70 million patients in those groups, it's that most of them don't currently seek treatment for elevated trigs, but that'll change in a blink if R-IT results in 30% reductions in CVD. R-IT is one of the biggest things in the market as far as potential to shape a company's fortunes. We are in the REDUCE-IT phase of AMRN now, all other priorities rescinded.