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BB. Glad you can’t leave the board. We understand your frustration with FDA, but only a matter of time until reduce it successful and AHA recommends Vascepa and Vascepa only!
-Long and strong amrn. Know what you own. Gluck all. Jan will begin the ascent.
BB. You are wrong. I’ll gladly buy your shares. You are underestimating How blockbuster this is. drug supplement will take a minority share.
People will be prescribed the drug that was tested in the trial not recommended to take some non regulated supplement.
Best
- Jo
BB- While I agree with some of your comments , the issue with AHA not so much.
Yes it stinks drug supplements are competing. I agree this is a legitimate issue. However, if you feel a reduce it win doesn’t help amrn, then may I ask why you are still in the stock ? If your frustrated And you are venting then totally understand ha.
As for AHA, If reduce it is successful, AHA will definitely not recommend any DS be okay to take. They will recommend a specific dose and it will be based off of the only data available (aka reduce it study) thus 4 grams of EE. No drug supplement can get you to that dose that the forecasted positive results will show. Thus amrn prevails.
Here’s a question - When trial ends let’s say Feb (whenever) , how many days/weeks do you think it’ll be until big money knows the results and starts to manipulate the stock.
BB- Agree I don’t trust the FDA either but if it shows positive end point the fda can’t withhold a potentially life saving treatment from patients for 1.5 years or more by time strength results are out.
Strength trial won’t be over until Nov 2019. Fda can’t hold amrn back until then with a successful reduce it trial.
100 % it will be used for primary prevention.
Agree trial is slated as a secondary prevention. However as I have mentioned in the past there are few drugs that have solid endpoints of reducing cardiovascular disease or even mortality. If reduce it is a big success it will be prescribed across the country as secondary prevention but also for primary prevention ahead of any more literature needed. Extrapolation of data by physicians as was done with aspirin (data based on 2ndary prevention but prescribed to just about anyone nowadays with a risk factor ).
B.B.- Thx makes sense. I didn’t realize they were putting that on the back of the bottle. Ridiculous.
BB- Excuse me if I am not up to speed on this. I am not a pharmacist and don’t claim to be one. However how come you state fish oil is not EE. I am not following the breakdown of the different compounds aside from the fact that synthetically produced EPA cannot be marketed as a drug supplement.
All these drug supplements are fish oils aren’t they ?
Thx
Don’t hit panic - Seems like panic button is getting hit here. Some nice posts today tho.
- Remember the drugs amazing effects haven’t changed. The evidence behind it is why you are in this.
- This ITC issue may seem like a bigger deal than it is. It’s background noise. Amazing if it goes our way but I expect hurdles along the way and amrn to still be a blockbuster hit. Doctors will follow this study if it does what we know it will.
- One thing I don’t get is how Vascepa can be granted approval and new chemical entity yet somehow concentrated fish oils on the market are allowed to be supplements without any patent infringement. In other words, at how much concentration of EPA is it a patent infringement. I assume there’s patents on that or is it that the purification process is our only argument ? Vascepa I believe is 96% epa. I want to say lovaza is about 40 something
Thanks to the board for any guidance here. Good luck and hold strong.
Any lawyers on the Board wanna weigh in on ITC?
HD - How come no news? Is that typical to not have a release even Monday after the 10/27 date has past
kiwi- all I can tell you and I am not going to stress the point any further is that MOST facilities are not as good as yours or even close. This flu issue has NO bearing on this trial.
Medical opinion. Take it for what it’s worth.
Have a good day.
Disagree that flu has any role in this trial and decreasing event rate whatsoever. Couldn’t feel stronger. Wish I had better numbers for you but I can tell you from experience.
It is not standard of care to follow up on patients and make sure or mandate they get the flu shot so there is a decent sized population at risk with CAd that don’t get the shot.
Hey whatla- Almost all patients should be vaccinated against flu. This year it’s a crappy vaccine but yes we recommend it to anyone greater than 65, heart disease asthma copd liver disease. Really most Americans get it recommended to them by PCPs especially the older patients bc those are more likely to be visiting a doctor in the first place.
Best treatment of flu is prevention.
Hope that is what your asking.
Whatla- That’s fairly rude. Your wife is entitled to her opinion. She is grossly misinformed.
1) Flu is largely clinical diagnosis. The vast majority of ERs across the country don’t test for flu even urgent care centers.
2) Reason not to test is the antiviral only works within 48 h and most people come to you after that time window. Also, the antiviral doesn’t work well and causes vomiting and even people within the 48 h rarely benefit from it. It is prescribed by old school physicians (PAs as well in urgi centers) not well versed in the literature.
3) people that get tested for the flu are those being admitted to the hospital and those with multiple comorbidities bad vital signs sicker overall patients. Those pts get tested bc you have to cohort them in the hospital in rooms without people that have the flu. Those pts get the antiviral bc there’s nothing else we can offer them. They die or have complications not necessarily from the flu but from post flu pneumonia or multi organ failure but the bias is they are already much sicker to begin with and it may not be the flu that killed them. However cdc numbers only show person was positive for flu and died.
Please be respectful.
Hope that clears it up.
The flu shot data is bs. most people do fine with the flu it’s a rarity to die or have significant complication from
The flu. happends but RARELy. numbers r skewed for a variety of reasons. doctors don’t even routinely test for the flu. We just tell the patient they have it so cdc has none of those large numbers of pts that do fine. They just see the pts that are being admitted and are sicker and those pts gets tested and are positive etc. Hope that makes sense.
Rose - Sorry I mean it is mostly number 2 plus likely other reasons I am not thinking of at the moment. Def not number 1.
RAF - it’s partially due to Number 2.
Compared to jelis we have an unhealthy American pop with worse baseline characteristics risk factors and lower overall EPA intake so placebo group is def dying/having cardiac events I can tell you that.
Vascepa arm probly doing better than expected.
Amrn ITC lawyer in put- others on board are attorneys appreciate there input too. My brother in law (attorney) reviewed the whole case and is adding money to amrn before Friday convinced ITC will take the case. He also believes amrn has as strong an argument as you can have in this type of complaint. Hope that helps others on the fence.
Not sure of price action Friday but I would think ITC taking the case is pretty damn positive.
Let’s see
Flounder - As bullish as I am with amrn I have to be honest and say no.
Couldbe- I’m not talking about short after reduce it results. That’s irrelevant. Point is there are few if any legitimate arguments as to why reduce it will fail. Id be happy to defend why reduce it would succeed to anyone.
- ER doc at heart
Shorts- Any shorts for reduce it trial out there that mind posting their opinion?
I put this trial at as close to a lock for success as you can have without the few percent chance of it being negative bc it still is a trial.
BB- no one read that comment from the article as negative? That bc the fda hasn’t done anything all this time they already know the topic and won’t do anything now ? That was my impression actually.
HD nice update on Amarns response. Actually a nice argument. It seems like ITC should take the case but I don’t like the interaction between FDA/amrn for the future. However I think amrn needed to do this and really they need to win. They can use this added protection. I don’t know what FDA is hinting at that their policies etc may change in future. That seems like absolute bs.
RAF - Let’s agree to move on. Not trying to restart this discussion.
ITC link - Can someone post link to the actual ITC case. I see above is just the website. My friend is a lawyer and would
Like to read the whole complaint /response etc and weigh in.
Thanks.
This back and forth is getting old. BB is def right in the way fda screwed over amrn investors. I understand the other side but it was unjustified.
Anyway, are we def getting an update on ITC action Friday?
When they use epa in these studies, what concentration do they use. It never really says in the literature so it makes it confusing.
Price - Do investors know news 10/20 not going to be favorable. Why the bottom falling out. Ah well. Can’t wait for reduce it.
Thx B.B.
Why would FDA go after respondents if amrn loses ITC? I appreciate your opinion but law is not my strong suit.
We are hoping amrn wins but in the event they don’t.
Thx.
Disagree big here. Standard of care is statin treatment. No IRB would approve a study without having statin on board. You mention statin intolerant patients can be enrolled. That is a small number of patients and would thus be harder to study.
This study is robust in its design and will absolutely be set to succeed. Read the literature out on EPA and this is high dose EPA in an unhealthy population. last year another article out showing EPA ability to reduce ACS. There's so much literature out there on its benefits it's overwhelming.
His videos r usually bullish tho so I am not sure what you mean unless I am mistaken.
When you read that article, it's like a set up for reduce it trial success.
Options play - I'm with you there. I have the same call options as well as stock. The options will explode after the results in the summer!
Amrn law suit QS- any attorneys out there know how long this process will be ? Is this going to be years or possibly a conclusion in next few months ?
Agree here. No one will forget how bad the FDA screwed us so many years ago.
With positive reduce it results (strong results ), how high you think it could pop in your opinion?
New article - vascepa compared to epadel from Japan.
2017 publication. Interesting read. This just reminded me of why I love amrn so much and why it is set up to succeed even more so than epadel did in Jelis.
Sicker patient pop in reduce it, blinded so more believable results when they r out , higher dose of EPA than in Jelis should improve its results, no major side effects. Plus multiple publications out demonstrating EPA ability to reduce atherosclerosis even beyond just lowering lipid parameters.
Long and strong amrn. Can't wait.
https://lipidworld.biomedcentral.com/track/pdf/10.1186/s12944-017-0415-8?site=lipidworld.biomedcentral.com
If that's the case, you would think the stock would bounce out of this range bound territory.
I hope amrn wins this. It just has bad history with FDA as we all know too well.