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Start with the various recommendations from the organizations and add in the ICER cost analysis before you worry about his specific questions.
This doctor is trying to save face. He doesn't want to tell you that he is not allowed to prescribe something that Kaiser doesn't want him to prescribe. They are managing your care, which means they are managing the cost of your care.
Are you in the U.S.? There are specific regulations surrounding prescription drug commercials.
That was not from the real flyonthewall website. Ignore it.
I don't think it is baked in to the price, I think it will move in that direction between now and the AdCom. At least some of the short interest will cover before AdCom as they have already started to cover based on last update. Those who have hesitated to get in will at least start taking a position.
You need to look at the recommendations from the different organizations and the marks that reduce-it is getting. Just this weekend NLA gave it a Class I recommendation. The other organizations have also given the trial design and recommendations very high marks. They do not believe that mineral oil has tainted the trial results. All of these organizations will come out in support of Amarin and Vascepa at the AdCom. Hell, the FDA will come out in support of Amarin at the AdCom. They are the ones that approved the trial and asked for Amarin to proceed with this Cardiovascular outcomes trial. Remember the results are far better than anyone thought. The only people still saying that the results are too good to be true are those without scientific backgrounds. They have to make a lot of noise but no one is going to believe them. MRC tried his M.O. arguments with ICER and got nowhere. NONE of the analyst are saying that the AdCom is going to go against Vascepa.
I think when Amarin gets approval we are going to see many new articles and news coverage.
Yes, after reaching 10B in sales, if you truly could lock up supply, you would never have to worry about a generic. I have to wonder whether they will buy back shares or give us a nice dividend or both. I would love to be around to find out.
The NLA has a member map. If someone is looking for a vascepa prescription and is having trouble, this may be a good place to start. https://www.lipid.org/member_map_v1
It will say adults. It is just guidance from the various organization that will guide the physicians on how and who to treat.
Amarin has great lawyers. Thanks for posting.
It bothers me as well at first, but a doctor is not going to say, this patient is at risk of a heart attack but he is not 45.
Is might appear narrow in some ways but the patients do not need to be on statins. That broadens the recommendation considerably.
Is the doc an endocrinologist? You should definitely revisit this doc and try again. If still not receptive I would try a different doc.
https://www.lipid.org/sites/default/files/276.fan_.wenjun.pdf
Courtosy of Greenday on twitter.
Whether he said it or not may not be the point. It was so long ago, Vascepa was not even on the market. They need to update that whole slide with current information. This was part of an introductory course for lipid management.
I am sure more more current information will be available tonight at the dinner and over the next two days.
That is probably daily short volume, not the short interest.
As far as indication, HLS has stated that they filed for same indication as Amarin to FDA. This description seems pretty clear to me.
Manufacturer Requested Reimbursement Criteria1: To reduce the risk of ischemic cardiovascular events (death due to cardiovascular event, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization, and unstable angina) in statin-treated patients with elevated triglycerides and other risk factors such as: established cardiovascular disease, or at high risk for cardiovascular disease.
They have stated elsewhere 135 is the level.
I wish they would get that BMY CELG deal done so it will free up all that cash for investors that like to invest in biotech.
I do understand how overworked they are. It might not be the physician but they do have physician assistants or others in the office very capable of working through this paperwork. ADA standard of care is a big plus for this process with diabetics. Prior authorizations and appeals are now part of the routine cost of doing business.
The FDA approved a priority review and is now delaying it. This is on the FDA.
Amarin expects approval by the end of the year. Since Vascepa is on the market, If a physician is passionate about getting Vascepa for a patient, they can write an appeal to the insurance company. I am sure that is happening every day. I know this is a long slog for patients and for shareholders but approval will happen before year end. It will all work out. Patience.
So this is just the Federal Register notice at this point. What does this have to do with diabetes indication. What else do you think you should be seeing here at this point in time?
The docket will get open. It will happen. I know that some will want to be first but IMO, It is probably better to wait to see what others post so that responses can be include in your response.
I think the FDA uses any excuse they can find as a reason for the delay. It does not have to be material.
So when the short interest goes up you (or someone like you) says that shorts are strong researchers and they have a strong conviction and AMRN is going to go to 9. Now when short interest goes down, I do the opposite. I say short interest is down and they must be covering as they realize they are in a losing position. Just having a little fun with you because I can. I hope you have a bad day.
Amarin should probably do a trial for patients with trigs> 135 that do not need a statin because their other lipids are fine. I fell into that category (Trigs floating around in the 200 range) and got my primary care to prescribe Vascepa. I went for several years with just Vascepa until she added a low dose statin.
Edited to add, Amarin should also do trial for those that are statin intolerant and are taking these PCsK9s.
for muscle pain get Co-Q-10 and while you are at it get the real deal, Vascepa. Start with 1 200mg Co-q-10 a day and see if that helps, if not, take a second one.
Short interest decrease - this came out last night, not sure if it has been posted. This should be a positive catalyst as those with short positions are now lacking conviction. Volume is also down so it will take longer to cover.
Amarin Corporation plc - American Depositary Shares, each representing one Ordinary Share
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
08/30/2019 41,817,249 (11.24) 6,312,991 6.62
08/15/2019 47,110,560 45.67 10,952,950 4.30
07/31/2019 32,340,985 1.14 11,005,447 2.94
07/15/2019 31,975,343 26.79 14,916,133 2.14
06/28/2019 25,220,121 (0.09) 4,572,385 5.52
06/14/2019 25,242,508 (4.90) 4,638,075 5.44
I probably didn't word that very good. We definitely need expanded label but if it doesn't include those intolerant to statins (as an example) , there is a way around it.
In all seriousness, putting aside the MRC clown show, ICER failed to truly address the legitimate concerns of Amarin and other organizations that were raised related to the draft report. They are a shill for the insurance agencies and are not going to go out of their way to put out a good report.
https://icer-review.org/material/cvd-icers-response-to-comments/
Vascepa is already on the market. For a drug already available on the market the FDA does not allow or not allow a patient to obtain a prescription. The prescription is just considered off label if it is not for an approved indication. if the patient has insurance issues, the physicians office should step in and assist with getting appropriate coverage. It is happening now so although the approved label is important, there are ways around it.
Is it really off label if those patients should also be taking statins. Get them back on statins and get them on Vascepa and they are on label.
Where do you get your information? Patients in Reduce-it took whatever statin they were taking when they enrolled in the trial.
We must be looking at different versions of it Is it in your cache?
patients with very high triglycerides at doses of 4 g per day, EPA+DHA reduce triglycerides by 30% or more. In reducing triglycerides only, EPA+DHA and EPA alone provided similar results.
Who are you trying to convince?
I would expect a slow and steady climb into November. I hope everyone has or soon gets all the shares they want.
Amarin Q&A on EMDAC meeting notice.
Has the FDA confirmed November 14, 2019 as the date for the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review Amarin’s supplemental new drug application related to the REDUCE-IT cardiovascular outcomes trial?
Yes. FDA confirmed that November 14, 2019 is the scheduled date for the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to review Amarin’s supplemental new drug application (sNDA) related to the REDUCE-ITTM cardiovascular outcomes trial. The Federal Register (FR) notice for the November 14, 2019 EMDAC meeting is on advanced display as of Wednesday, September 11, 2019 and is scheduled to fully publish on Thursday, September 12, 2019.
The advanced display notice contains FDA’s summary of Amarin’s proposed indication statement based on REDUCE-IT results for use of Vascepa® (icosapent ethyl) capsules 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.
Language proposed by Amarin for an expanded label for Vascepa is intended to reflect the patient population studied in REDUCE-IT and the results of REDUCE-IT, in particular:
• Reduction in five-point MACE (MI, stroke, CV death, revascularization, hospitalization for unstable angina),
• Not a replacement for statin therapy but as an incremental and separate prescription treatment option for patients at risk for CV events,
• CV risk identified beyond cholesterol management to include patients with elevated TG levels and other CV risk factors,
• TG levels of >135 mg/dL specified as that is the population studied in REDUCE-IT as elevated TG levels are a good identifier of risk (it being recognized that lowering TG levels alone are not validated as an FDA-approved surrogate for CV risk reduction, REDUCE-IT is not designed to validate TGs as a surrogate and the effects of Vascepa go beyond TG lowering),
• Other CV risk factors are well understood by medical professionals and further delineation of such risks in the label is likely to clutter the label, confuse patients and lead to unnecessary insurance- related issues that we do not believe should be encouraged for a cost-effective drug like Vascepa, and
• Emphasis in the label should be on 4 grams per day (2 grams twice daily).
For a label to be complete, it would also be accompanied by fair balance (e.g. safety information) which,
consistent with drug labeling, is not part of the proposed indication statement.
As previously disclosed, Amarin does not expect the FDA to take action on the sNDA by the previously announced September 28, 2019 Prescription Drug User Fee Act (PDUFA) goal date. Amarin has not received notice from the FDA of a PDUFA date extension. Amarin plans to update the investment community after appropriately definitive information is available related to a new PDUFA date.
Additional information on the EMDAC meeting, including links to the official notice, information about the meeting and how to comment on the meeting is set forth below:
Title: Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Docket No.: FDA-2019-N-3936
Throw out all the noise. The company thought there would be an AdCom because of the size of the label and so it will occur. Delay of announcement is the noise. Big label, big AdCom discussion on Nov 14th with a approval before year end. It is going to be a good fall.
I have reviewed many Federal register notices for Advisory committees and have never seen a PDUFA date mentioned. I don't think it was a slight. I would say AMRN will put out a little press release tonight or in the morning and they will let us know if they have been notified if the PDUFA will be delayed or the FDA will stick with the initial date.
Once again, there is no indication that the PDUFA date will be delayed. It is the FDA's fault that they failed to schedule AdCom in August. AdCom will be November 14th and then they will have final label negotiations. Final approval will come before the end of the year.