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Thank you for posting. When I see this chart, I also imagine all of the patients taking Fibrates and Niacin and D/S Fish oil that should be taking Vascepa.
Education is occurring, it is just going to take time. Amarin and Vascepa were at AAFP.org last week and did their presentations on Vascepa. Presentations at grand rounds are occurring and standards of care are starting to change. I know it can't happen quick enough for us, but it is happening.
IMO, Based on the data collected (per the supplemental disclosure), they are going to be releasing studies for at least the next five years.
Of course he was aggravated. He was aggravated because of the delay, not because of the AdCom.
Your whole premise starts with this.
"So now the company faces an ADCOM that by and large many did not expect. "
JT said all along he expected an AdCom due to the size of the label. That is what we got. That is what was expected. Most longs are not understandably nervous. There may be a few vocal ones here but I suspect that is just folks talking their book.
What are you talking about "Mary Parks is in charge of the REDUCE-IT sNDA." ??
I agree.
The label is definitely still up in the air. The whole discussion at ICER about label creep was very interesting. Doc's will prescribe no matter what the label but I believe the docs think the label will be fairly broad.
That is more crazy talk.
It is on page 30. I did a Command and F (for Find) and did a search for AA.
Using archived frozen serum biosamples: additional analyses of fatty-acid levels (and ratios), including baseline and on-treatment effects on EPA, DHA, DPA, AA (and associated ratios) and relationships between fatty-acid levels and cardiovascular outcomes.
That is not true. It is right there in the supplement.
"Using archived frozen serum biosamples: additional analyses of fatty-acid levels (and ratios), including baseline and on-treatment effects on EPA, DHA, DPA, AA (and associated ratios) and relationships between fatty-acid levels and cardiovascular outcomes.
"
Not only the significance of it but also the cost. Amarin has the money to take this trial to its full conclusion.
It is because of the market cap and the perceived risk. That risk will be gone soon. The market cap will be much higher. Patience.
Here is a copy of the supplemental data from reduce-it. It includes the EPA levels and other great information. It is out on the internet in a weird place, but I have it bookmarked so I can find it when I want to look at it.
http://www.natap.org/2018/HIV/nejmoa1812792_appendix.pdf
Articles that are not true, such as the one you just posted. Fear, Uncertainty and doubt. Research it yourself and you would have known.
That is from the motley fool article. There were three contracts at the $9 strike price and there still are today. That is FUD. I like how they say the Truth is, without any proof.
Where have you read that at? What is your source, can we have a link? Or is it just FUD? I have seen it happen both ways based on the materials.
It has been a long road. MRC is cracking up over on twitter, he thinks Evaporate was stopped because of M.O. in the placebo. What a nut.
If you can't think rationally about it then you may need to walk away from this board and understand what is happening in the real world.
Scripts are rising and physician awareness is growing. Dr. Bhatt did a big presentation last night for family practice physicians. Reduce-it results are going mainstream. Canada fast track approval before year end. The AdCom notice says nothing about M.O., risk or safety. Amarin did everything the FDA asked. Reduce-it results are stellar.
We could wake up any morning to submission in Europe. Recent language from Amarin changed from before the end fo the year to fourth quarter submission.
HLS is expecting approval in Canada before the end of the year with launch in 1st Qtr 2020. If FDA actually waits until PDUFA date, Canada will actually approve a drug before the FDA. That will be quite a sight to see and I expect there will be much publicity regarding that. After the stellar Reduce-it results, HLS expects to gladly pay out all of their milestones to Amarin. We should also be seeing more information coming out of Cadth before the end of the year on their drug review.
This is going to come down to sales. As sales continue to escalate there will still be those that say but what about the M.O and the intellectual property. Amarin will crush any remaining doubts in the next four months.
There is some crazy talk on this board right now. Not sure where it is coming from. All you have to do is look at the biomarkers on the Vascepa side of the trial to know that the effect of Vascepa is real. All you have to do is reflect on what people here have said about how they feel taking Vascepa. You do not see inflammation and lipid biomarkers go down over the course of 5 years. A few folks are going to get scared out of their shares but most know what they own.
Do you know what it was they gave you?
No. " If a P value of ≤0.006 is achieved at 9?months, then the study will terminate because the efficacy boundary will have been achieved. "
So it was a 9 month stop, however some patients were on it as long as 18 months.
Viet Le PA-C, AACC
@VietHeartPA
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1h
Replying to
@VietHeartPA
@GPUWorld
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@AHAMeetings
I cannot speak in any official capacity, will defer to central site and overall study PI. However, note that the design included a 9 month stop if endpoints were met. Given rolling enrollment, there would be some who made it to 18 months.
Stopped at interim, it is favorable.
there is no PROOF here. it all depends on what discussions occurred prior to th AHA accepting the data,
Get some rest BB. That is not the primary objective of the AdCom. It was the primary objective of the trial per clinical trials.gov 'A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. 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)"
What are you talking about. AMRN has NEVER indicated the delay is due to labeling issues.
Yes, they could. We could still get top-line before then but details may wait until AHA.
In 28 days or so. you might just ask the Pharmacy to ask the doctor to refill the script. It's possible the guy lets it happen.
Kaiser has been this way for years. The doctors are owned by the insurance company. That does not mean it will happen elsewhere. They manage the care and the patients either get along with it or they change physicians and insurances. This is not something new. It has been talked about in regards to Vascepa since 2012. It is not just Vascepa, it is mental health benefits, it is access to drugs, it is bariatric surgery. Kaiser does everything they can to save a buck. They save money by managing your care. HMO. This should not be a surprise to anyone here. If it is a surprise, you have not been paying attention to the insurance market in the U.S. HMO's have come and gone in America. Kaiser is one that remains. It is not a new trend, it is an old trend.
The Yee video from last week probably offset the good news. I think Yee has clients who want shares.
The Yee video from last week probably offset the good news. I think Yee has clients who want shares.
I don't think they will be putting anything else out. I don't like it any more than BB does but they have disclaimers in their regulatory filings about not discussing details of ongoing discussions. I think they are covered.
He says he has PHP. You guys need to let the Kaiser issue go away. Kaiser is an aggressively managed healthcare plan and they are not going to cover Vascepa until the label is expanded.
He is from Cleveland Clinic in Abu Dhabi. I doubt even Nissen has that kind of power.
Your insurance isn't paying for it anyway. You should just find a lipidologist to prescribe it. You could always get a CAC score test to back up your need. Here is a link to the NLA physician members https://www.lipid.org/member_map_v1
IMO, The FDA label will not be as detailed as the NLA. The FDA is not going to tell a 42 year old they have to wait three years to get the drug. It will be up to the various organizations as to how they will recommend physicians prescribing it and physicians will prescribe it as they see fit.
Just curious, what were you paying for Vascepa, as prescribed by your cardiology acquaintance.
edited to add - What happens at Kaiser is not indicative of what happens around the rest of the country. We need an FDA approved indication before we can fight this particular battle.
Check the drug formulary for Kaiser. If Vascepa is not on the preferred list, I would assume it is the company.