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This is about the large label.
The primary objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)” The committee will discuss supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin.
Agree that it is truthful but misleading. I think we need to focus on the AHA itself and their recommendation instead of on this Practice Update.
They didn't rewrite it, they just took out that sentence and replaced it with "In reducing triglycerides only, EPA+DHA and EPA alone provided similar results."
Hey you guys can like my tweets as well so the whole thread is elevated.
Dr Bhatt just liked both my tweets and responded to me that "You are correct. I also pointed out to them that they reported the data backwards and that it is EPA that lowers LDL and DHA that raises it. "
I have let them know.
Wow, they did already rewrite it.
I put a tweet out to Practice Update and included Dr Bhatt and #cardiotwitter.
@practiceupdate
Practice Update, you have your Take Home Message backwards. It should read " At doses of 4 g per day, EPA alone, but not EPA/DHA decreased LDL cholesterol as well as triglyceride levels"
@DLBHATTMD #cardiotwitter #vascepa https://practiceupdate.com/journalscan/60455/2/2?elsca1=emc_enews_daily-digest&elsca2=email&elsca3=practiceupdate_cardio&elsca4=cardiology&elsca5=newsletter&rid=NDE0ODg4MzcyNjMyS0&lid=10332481
If AMRN ever does get bought out, I am likely to put my proceeds in a basket of Baker Brothers stocks.
Yes, as JT said during a previous conference call. paraphrasing -- We are answering all questions as quickly as possible.
Major amendments get 3 month delays. That has nothing to do with the FDA not scheduling their AdCom in August as they should have.
"December 28th is Very Unlikely PDUFA Date " PDUFA date is Sept 28th, there is no reason for the FDA to delay it at this point. They failed to schedule in August so PDUFA will likely stay Sept 28th.
Vascepa has efficacy and safety including a 7 year track record of being on the market. It will be approved. You are not missing anything.
·
A little conversation from twitter last night -
Sep 9
Citi positive comments $AMRN Biotech Conference Takeaways — hosted two cardiologists at conference. Potential Market for Vascepa is Very Large – Both agreed that REDUCE-IT was one of the more important clinical trials in years and that results of this magnitude can’t be ignored.
dough
@semodough
KOLs indicated “millions and millions” of people could benefit from Vascepa. When we asked what percentage of patients on statins should also be on Vascepa, one doc indicated ~1/4 and our other doc suggested ~1/3.
16h
Replying to
@semodough
If you calculate based on those indications:
- 38M on statins (US) per $amrn presentation
- 1/3=12,7M; 1/4=9,5M
- mean = 11M x 1625 USD/y = 18B USD/year
- 18B x 3 = 54B mcap = 164 USD/share
Can this be realistic?
Institutional ownership is going up along with short interest. Institutions have been shorting the stock to lower the price so they can buy in. Retail, probably because of this message board, still has a hold on this stock. Market for Vascepa is huge and institutions know it. Last secondary was at 18 and they shorted against those positions and are trying to buy more now. They are trying to scare you out of your shares while we wait. Motley Fool article is just part of the nonsense yesterday.
Glad he is pushing back. So much for evidence based recommendations.
Some news out this morning on another biotech $ITCI reports that the FDA does not plan an AdComm Mtg that had been scheduled for next week for the review of Lumateperone. PDUFA date is Dec 27, 2019.
Whether he is getting smacked down in a hole periodically doesn't really matter if it doesn't happen consistently. Because of his post on twitter, he is the face of Amarin sentiment. This little message board here is nothing compared to the widespread attention that twitter gets.
Normally when the Adcom is officially announced there is drop in share price but this Adcom was announced by Amarin. The drop has already occurred. Next thing to happen will be the official announcement of an already announced Adcom. This announcement will give details we do not have and will lead to certainty about what the issues are that the FDA wants to discuss. If the details are primarily about addressable market the reaction will be very positive.
It does not matter how many followers he has. Anyone searching for $AMRN or Vascepa or Reduce-it can read his posts. He overwhelmed the threads with his posts.
I wish that instead of worrying about followers someone with a statistics background and a good understanding of Reduce-it would go over to twitter and straighten him out. He goes unchallenged and does not help Amarin or Vascepa.
8:45 conference call link http://wsw.com/webcast/hcw5/amrn/index.aspx
Sam, thanks for your contributions to the board. Just curious, do you feel better? Any positive side effects you care to share?
This is a big deal and great news. So much of what has come out has been from physicians associated with Amarin. We will hear from many others except for the Cleveland Clinic. Nissan et al is too busy promoting bariatric surgery that Cleveland Clinic makes so much money on. Let the patients get fat and then we can clamp off half their stomach so they can eat mush for the rest of their lives.
I did see yesterday that there is a physician doing a presentation in S. Korea on Reduce-It this week. The word is spreading.
There has been some huge bets this week on where the share price is going to be. That is just one of them.
AMRN goes down most mornings. That doesn't mean it will stay that way.
The population that Vascepa WILL prevent cardiovascular death is very, very small and more difficult to accurately identify (which is meh...)
Please post your evidence.
I agree, that is why Amarin is getting ahead of AZN's game. JT has that in his back pocket and can use it for the next several years. The KOLs and sales reps also know this and so will the medical community.
This company has been in survival mode with a small label and limited insurance coverage for the small label and having to fund an expensive multi year study. With approval for a broad label, that is about to change. They need that approval first before they can give the country. Get it further entrenched in the guidelines and it will be known. If physicians aren't reading and using guidelines they are not very good physicians.
"It’s obvious AZN has significant interest in Amarin and its obvious Amarin is prepared to entertain interest, why else would JT know Vascepa RRR 38% in STRENGTH cohort... "
I just see this as Amarin being ready for future competition. All they had to do was look at the criteria for inclusion into STRENGTH and ask their data analysis group to run a detailed analysis on this subgroup. It shows that for a small pharma, they are on top of it. I think it really took the Citi analyst off guard. He was surprised by the number and that JT had it available.
If you had said FDA has continued to kill since Anchor I would have agreed with that. Those who could afford and are in the know have gotten Vascepa. Those who didn't know or couldn't afford have not. If Amarin would have received approval the coverage had been better on Vascepa for the last 7 years we would be at many billion in sales at this point even without the CVOT.
My doctor quit practicing several years ago so when I switched to my new doctor made me go through niacin and fibrates and something else before we settled back on Vascepa. It was holy hell. Only reason I am in as good of shape as I am is because I was not going to go without it. My doc is a believer now but I still don't think she has prescribed for anyone else because of what she perceives as the cost issue. She is internal med, I don't have a cardiologist. I should say I feel so good I really only go see her once a year. When I went at the beginning of the year I did bring up that there was a new study reduce-it that she should look at. I have not been back in to follow up.
"JT mention 10 billion as a target they want to have enough inventory for. " That's not what was said.
I think it can be approved, the FDA does not do patent reviews. It can be approved, Amarin would just have to take it back to court so that they stop it from violating the patents.
I don't think they are killing but they are definitely not helping. The FDA wanted proof and now they have it and they are being slow to act on it. Typical government bureaucracy. I think they have created in inequity where those who are aware of Vascepa and can afford it are getting it and those who can't are left in the dark.
The AHA also seems to be more political than I would have thought. JT said today "European Society of Cardiology, is trying to ensure that they are at the forefront of cardiovascular medicine, not just for Europe but globally. And they saw that the incorporation of icosapent ethyl which is Vascepa in their guidelines make sense for treatment of patients. And what they were looking for and recommended in their guidelines is that Vascepa be considered for treatment of patients who despite statin treatment had elevated triglycerides." That to me is aimed at the AHA who have a long way to go with their next updated guideline.
"Our aim is to submit to the European authorities at sometime in the fourth quarter of this year." JT from the fireside chat today
This is a little different take. Instead of before the end of the year, he has stated sometime in the fourth quarter. I am going to see that as a positive as it could happen now any time after October 1st.
Here is a link to the transcript by the way. https://seekingalpha.com/article/4289695-amarin-corporations-amrn-ceo-presents-citis-14th-annual-biotech-conference-transcript
There have been 44,000 calls purchased today vs 5,000 puts.
4x the normal number of calls vs a relatively normal number of puts.
Just to be clear, the 10's of millions that JT throws around is patients, not revenue. The 10B number is a revenue estimate that some models are showing possible. JT made it clear that that number is not part of their guidance. The idea that he thinks they can get their as far as manufacturing constraights is a game changer for current stock price. Not having potential for manufacturing capacity that high has been part of the short interest thesis.
It could just be JT doing investor one on one's prior to his fireside chat. If he is as enthusiastic today as he was during the Bloomberg interview, I could see this happening. A new institutional investor or two could make this happen.
How about doing "the wave" I just stood up and threw my hands up in the air. Now it is your turn.
Yes, JT has stated that if he had news of an AdCom he would notify shareholders and that is what he did. He did the right thing.
The laws are not that specific to what is material. The laws do not have specific things regarding companies that deal with the FDA. They do not have specific laws for different types of companies. They are laws for all types of companies. Sued based on having material information that he didn't share. If ohers are trading on that information and it turns out he failed to report it to shareholders. That's what. Remember the puts bought the day before he announced it. Have you not heard of shareholder lawsuits?