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Glad you are okay.
Leerink initiated coverage with a $28 price target. Pre-market seems legit. A couple of bids now at 14.53.
So you are telling me the diabetes population of Reduce-It was not statistically significant and Whale is telling me the non-diabetic population of Reduce-it was not statistically significant.
I know the ICER is not the FDA. I was just trying to point out there was benefit. Here is the ICER draft report. https://icer-review.org/material/cvd-draft-evidence-report/
Per ICER - A consistent treatment benefit was observed for both the primary and key secondary composite endpoints in subgroups with and without diabetes mellitus, with and without renal dysfunction (eGFR<60 vs. ≥60 mL/min/1.732), with and without elevated triglyceride levels (≥150 vs. <150 mg/dL and ≥200 vs. <200 mg/dL), and in subgroups stratified by hsCRP level at baseline (≤2 vs >2 mg/L)
They can't ignore a consistent treatment benefit. There could also be subgroup analysis within the non-diabetics and there is also Anchor.
This isn't just about diabetics and you know that. You can't exclude patients with heart disease that do not have blood sugar issues.
You might want to listen to the call again. What I remember was JT telling the analyst that they would need to see the questions and concerns of the FDA before they decide who would be there.
Apparently I addressed my post to the wrong person. What I stated still holds. People should leave this guy alone.
Nissen is not serving on any public committees at this point in his career. Leave him alone.
Fantastic. Thank you for taking the time to put this together. I am sure your time is valuable.
The FDA does not have a four day rule. They do not have to report anything to the SEC that is material and do not have the same rules. They have their own rules regarding postings to the Federal Register. Amarin because it is required to follow SEC regulations was required to report receiving material information within the four days. JT was right to go ahead and report this to shareholders and the SEC, he did the right thing. The FDA is not subject to the same rules.
Dr. Nissen is not an AdCom member and the FDA should not be asking him any questions about it.
"But R-IT didn't show efficacy for primary prevention" What are you saying here? I thought that the patients that had diabetes mellitus and at least one additional risk factor (the primary prevention cohort) had very good results.
"I just hope he doesn’t have much sway with the ACC as he was acting President for a year, on the board of trustees for 10, and has served several terms on the Program Committee for the ACC Annual Scientific Sessions. "
Those are all was's. He does not hold those positions now. He is a has been because of his bias and the only people quoting him are Matthew Herper and Adam F.
Amarin's attorneys did a partial summary judgement because they were working on limiting what could be introduced at the trial. They were working on narrowing the scope of the arguments. The other attorneys just filed an argument (without merit) saying that the case should be dismissed.
So far, claims construction went clearly in Amarin's favor. During discovery, witness testimony from Hikma's side was very poor. Because their witnesses did not testify regarding several sections of the law and how Amarin's claims are invalid, the judge should rule that Hikma can not bring up these other sections of the law and ambush Amarin's attorneys during the trial. If the judge rules in favor of Amarin's partial summary judgement, Hikma will be more likely to settle because their chance of winning at a trial would be reduced. If the judge rules in favor of Amarin's partial summary judgement, Hikma lawyers could only use obviousness as a defense.
Something else that has moved in Amarin's favor recent. JT recently said “The court has allowed us to introduce the results of the REDUCE-IT study, which we think supports the uniqueness of Vascepa.”.
put these two last things together. If the judge rules in favor of Amarin's partial summary judgement Hikma lawyers could only use obviousness as a defense and Amarin can use reduce-ti results. I am not a patent attorney or even an attorney but common sense tells me that there is no way that Hikma can claim that the results of Icosapent ethyl have been obvious. This is where Amarin starts quoting Adam F. and Physicians on the advisory committee who were genuinely surprised by the results.
IMO, we need to focus on the FDA. TEVA settled and Hikma is putting up a really poor defense. IMO after looking at this, we do not need to focus our time on this.
I would think the next catalyst will be when the judge rules on the PSJ and the SJ. IMO, it should be a good day.
"MO substantially obviates the benefit of statins" How can that be when he placebo group was still in what is considered a healthy cholesterol range? How can it be that the patients in the placebo group took a year longer to have events than what was projected at the onset of the trial.
I
Well that is a review by an individual, not the publication. This is an example where people like yourself lose credibility.
Thank you for your reply. I have not been around as long as you and appreciate your perspective. The Adcom questions in this previous example were about cardiovascular risk reduction. Despite the similarities, Why do you think this is just about MO? This seems counter-intuitive to me.
"This ADCOM wasn't convened to argue 135 vs 150 trigs on the label or primary vs secondary population. This ADCom was convened to explore and discuss the MO placebo"
Example - Advisory Committee (with no mineral oil) for sNDA so Advisory committee could say there is substantial evidence of cardiovascular risk reduction
Novo Nordisk receives positive 17-2 vote from FDA Advisory Committee that Victoza® provides substantial evidence of cardiovascular risk reduction in patients with type 2 diabetes
June 20, 2017 6:58 PM EDT
PLAINSBORO, N.J., June 20, 2017 /PRNewswire/ -- Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has completed its meeting regarding the supplemental New Drug Application (sNDA) for inclusion of the data from the cardiovascular outcomes trial LEADER in the label of Victoza® (liraglutide) injection 1.2 mg or 1.8 mg.
The discussions at the Advisory Committee meeting were based on data from the LEADER trial, which involved more than 9,300 people with type 2 diabetes at high risk of major cardiovascular events.
The Advisory Committee voted unanimously 19-0 in favor of Victoza® on the question: "Do the results of LEADER establish that use of Victoza® in patients with type 2 diabetes is not associated with excess cardiovascular risk?"
The Advisory Committee voted 17-2 in favor of Victoza® on the question: "Does the LEADER trial provide the substantial evidence needed to establish that Victoza® (liraglutide) 1.8 mg reduces cardiovascular risk in patients with type 2 diabetes?"
"Cardiovascular disease is the number one cause of death for people with type 2 diabetes, and today's discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1c control in this population," said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk. "The positive vote from EMDAC puts us one step closer to expanding our offering to reduce the risk of cardiovascular events in people with type 2 diabetes."
The sNDA for Victoza® was submitted to the FDA in October 2016 and regulatory feedback in the US is expected in Q3 2017. In Europe, a Type II Variation application was submitted to the European Medicines Agency (EMA) in October 2016.
About advisory committeesFDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing data concerning the safety and effectiveness of marketed or new drug applications.
About LEADERLEADER was a multicenter, international, randomized, double-blind, placebo-controlled trial investigating the long-term (3.5–5 years) effects of Victoza® (liraglutide up to 1.8 mg) compared to placebo, both in addition to standard of care, in people with type 2 diabetes at high risk of major cardiovascular events. Standard of care was comprised of lifestyle modifications, glucose-lowering treatments and cardiovascular medications.
LEADER was initiated in September 2010 and randomized 9,340 people with type 2 diabetes from 32 countries. The primary endpoint was the first occurrence of a composite cardiovascular outcome comprising cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Indication and Usage
What is Victoza®?Victoza® (liraglutide) injection 1.2 mg or 1.8 mg is an injectable prescription medicine that may improve blood sugar (glucose) in adults with type 2 diabetes, and should be used along with diet and exercise.
Victoza® is not recommended as the first choice of medicine for treating diabetes.
It is not known if Victoza® can be used in people who have had pancreatitis.
Victoza® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
It is not known if Victoza® can be used with mealtime insulin.
It is not known if Victoza® is safe and effective for use in children.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Victoza®?
Victoza® may cause serious side effects, including:
Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Victoza® and medicines that work like Victoza® caused thyroid tumors, including thyroid cancer. It is not known if Victoza® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Who should not use Victoza®?
Do not use Victoza® if:
you or any of your family have ever had MTC or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
you are allergic to liraglutide or any of the ingredients in Victoza®.
What should I tell my health care provider before using Victoza®?
Before using Victoza®, tell your health care provider if you:
have or have had problems with your pancreas, kidneys, or liver.
have any other medical conditions or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food.
are pregnant or breastfeeding or plan to become pregnant or breastfeed.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and other medicines to treat diabetes, including insulin or sulfonylureas.
How should I use Victoza®?
Do not mix insulin and Victoza® together in the same injection.
You may give an injection of Victoza® and insulin in the same body area (such as your stomach area), but not right next to each other.
Do not share your Victoza® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What are the possible side effects of Victoza®?
Victoza® may cause serious side effects, including:
inflammation of your pancreas (pancreatitis). Stop using Victoza® and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Victoza® with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse.
serious allergic reactions. Stop using Victoza® and get medical help right away if you have any symptoms of a serious allergic reaction, including itching, rash, or difficulty breathing.
The most common side effects of Victoza® may include headache, nausea, diarrhea, vomiting, and anti-liraglutide antibodies in your blood.
Please click here for Prescribing Information and Medication Guide.
About Victoza® (liraglutide)Victoza® is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration on January 25, 2010, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
As of March 2015, Victoza® has been commercially launched in 75 countries, including the United States, Canada, Japan, United Kingdom, Germany, France, Italy, Denmark, Hungary, Russia, India, Brazil, Mexico, Argentina, Malaysia and China.
About Novo NordiskNovo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
Victoza® is a registered trademark of Novo Nordisk A/S.Novo Nordisk is a registered trademark of Novo Nordisk A/S. All other trademarks, registered or unregistered, are the property of their respective owners.
Vascepa would be the first drug approved based on the large patient population studied in REDUCE-IT. Not sure what about that you are missing. Patients taking statins with trigs > 135. Statins have the label, why not Vascepa. Amarin successfully completed a Cardiovascular Outcomes Study. It is a drug for cardiovascular patient, some of whom have diabetes. They should get this label.
Does anyone know of any other company that conducted a very successful CVOT trial that did not get the broad label they requested?
Which guy on Stocktwits would that be?
MRC seems to have two new followers parroting his talking points. One of them Pablo Mendoza
@fpscod9 has not tweeting about anything else, ever.
·
Whatever label they are seeking is not just "based solely on R-It data". Much more data and other populations have been studied. What about Anchor, are you saying they should't get an indication for that?
For some reason he think that the indication that Amarin has requested is less than 3.5 million people?
He is going off the rails.
We need the detail for the defendants summary judgement before we can discuss it. I would say it is crap.
Normally when a drug company sends their experts to testify about patents they are able to speak to the various types of ways the patents should be invalidated. West and Reddy's expert only spoke about the obviousness Section 103. Amarin's attorneys are asking the judge to say we win for novelty (section 102) and written description/enablement (sect. 112). It is very common that experts speak on all of these things so that when you get to trial you can bring up other arguments as the trial progresses. Because their experts did not speak about these other issues, Amarin's attorneys are asking that the judge throw out the other reasons to overturn patents. Amarin is stating they should not be blindsided in court by arguments that were not made in pre-trial discovery. You can't just have attorneys arguing these complicated matters when there are no experts speaking about them.
Hang in there. Nothing is as bad as it first appears. I think many of us suffered a shock last night. Please find someone to talk to about it and whatever else is going on.
Short Interest just posted and surprise, it went up again.
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
7/31/2019 32,340,985 11,005,447 2.938634
7/15/2019 31,975,343 14,916,133 2.143675
6/28/2019 25,220,121 4,572,385 5.515747
6/14/2019 25,242,508 4,638,075 5.442454
5/31/2019 26,542,109 6,245,726 4.249644
5/15/2019 25,577,533 5,083,965 5.031021
4/30/2019 23,732,579 5,442,797 4.360365
4/15/2019 21,911,936 5,652,460 3.876531
I agree with this. Smaller indication before PDUFA date, AdCom to decide bigger indication.
If that is true, this is nothing more than an AdCom for label discussion. No safety concerns, no mineral oil concerns.
"Hope some one can correct me on this but from memory primary prevention data was not stat sig yet JT wants this group included on the label " You should probably actually eview things instead of just going with your memory.
Reduce-it had both Primary and Secondary patients, 70% were primary.
Study
REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl—Intervention Trial)
Design
Phase IIIb, multicenter, double-blind, placebo-controlled, randomized trial with parallel assignment
Inclusion Criteria
General Criteria
• ≥45 years with established CVD (Secondary Prevention Cohort) OR
≥50 years with diabetes mellitus and ≥1 additional risk factor for CVD (Primary Prevention Cohort)
• Fasting triglyceride levels ≥135 mg/dL and <500 mg/dL
• LDL-C >40 mg/dL and ≤100 mg/dL
• On stable statin therapy (with or without ezetimibe) for ≥4 weeks
Secondary Prevention Cohort (≥45 years with ≥1 of the following):
• Documented CAD (≥1 of the following):
o Documented multivessel CAD (≥50% stenosis in ≥2 major arteries, with or without revascularization) o Documented prior MI
o Hospitalization for high risk NSTE-ACS
• Documented cerebrovascular or carotid disease (≥1 of the following): o Prior ischemic stroke
o Symptomatic carotid artery disease with ≥50% carotid arterial stenosis o Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis o History of carotid revascularization
• Documented PAD (≥1 of the following):
o Ankle-brachial index <0.9 with symptoms of intermittent claudication or o History of aortoiliac or peripheral arterial intervention
Primary Prevention Cohort (≥50 years with diabetes mellitus and ≥1 of the following additional risk factors for CVD):
• Men ≥55 years and women ≥65 years
• Cigarette smoker within three months
• Hypertension (SBP ≥140 mm Hg OR DBP ≥90 mm Hg)
• HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women
• hsCRP >3 mg/L
• Renal dysfunction
• Retinopathy
• Micro- or macroalbuminuria
• Ankle-brachial index <0.9 without symptoms of intermittent claudication
]
The AdCom should have been set up right from the beginning.
Retail that bought didn't get raped. It will just be a bump in the road for many of us. For those with big losses you will learn not to trade options and learn not to go into margin on these kinds of stocks. Hang in there though, it is bouncing back.
Those FOIA request were closed by the FDA in July.
Institutions may buy this up pretty quick. Do not give up on your positions yet.
Thank you Sam. I appreciate all that you have done and I hope you will hang around in the future.