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Overall my thoughts, AMRN very well prepared, FDA fumbling, FDA believes M.O. is not an issue and is off the table. 2 Adcom members , one conflicted and one have statistical issues seem to have problems with data. Hopefully AMRN will get a change to follow back up with answers the FDA could not answer in that last "clarifying questions" section.
They have gone to lunch, reconvene at 1:05. Maybe you can try and get back in before then. Good luck.
It helps. M.O. could impact increase risk of 3% in placebo group.
I just got into the meeting link. Hopefully others will be able to as well.
10% of the patients had trigs 135-150, that is more than a small cohort.
BB This is how it actually reads. It is not an either/or, there are three separate populations discussed here.
Discuss whether the efficacy and safety data from the REDUCE-IT trial provide substantial evidence to support approval of an indication for Vascepa to reduce the risk of cardiovascular events.
If yes, discuss the population – beyond patients with established CVD – that should be included in the indication. Options could include, but are not limited to:
• adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for CVD, without regard for age, diabetes status, or adequacy of LDL-C control (proposed by applicant).
• Risk Cohort 2, which represented 30% of the REDUCE-IT trial population and comprised patients aged 50 years and older without established CVD, who had diabetes, one or more additional risk factors for CVD, and hypertriglyceridemia despite optimized statin therapy to achieve LDL-C less than 100 mg/dL.
,
I did not read it that way. They are saying patients with established CVD, plus 1 and/or 2. They are three different populations. It is not an either or.
All of the FDA documents are searchable. There are three tables 40,41,42 that talk about aspirin and other treatments that patients were on.
Yes to both, just because the FDA asks for data does not mean it comes back negative.
You can do a search for "request" in the FDA document and see all the different tables that were added based on information requested by the FDA from Amarin. When you can do this search you can also see the various dates. Blood Pressure data and breakdown by statin type seem to be the two big ones.
Talk about spectulation, you are talking about there being a delay when there isn't one.
It's probably good that Amarin is no longer associated with Kowa.
I am sure most here know this is total BS.
The FDA is closed for Veterans Day. It should be tomorrow.
The Wednesday Nov 13th briefing documents come out on Friday so it probably makes sense to me that we will not see Amarin's briefing documents until Tuesday morning.
AVII77, you are the man, or the woman. Thank you for being here and sharing your expertise.
There is no comparison in these trials and you know it. Why did you not include the other non-diabetic population? You make it appear there would only be one question for one of the populations and make it appear negative. This other trial had over 40% of the patients discontinue because of side effects. That factors into how physicians would answer a questions and while we are at it 6% vs 12 % is very different.
Why would you compare the diabetes population of one trial with the non-diabetic population of another trial?
I think what Atom did nothing to help the short case. The responses to his post were clear and consise. It helped me (and i am sure others) understand the data better. Thanks to those that responded.
This is not what I was saying "You think statin alone taken at bedtime can beat AMR102 taken BID?" I guess my answer is that hopefully Amarin uses a statin with a longer half-life so that is working in your system at the optimum time, overnight.
This is funny but what is really sad is that MRC over on twitter actually thinks this is directed at him.
Let me know how they will get around this issue. Majority of statins are scripted to be taken at bedtime while Vascepa is taken with meals. How will they work that out? Will they just up the statin dose since it is not taken at the optimum time?
IMO, When MRC and Scrying start a conversation, they sound like two peas in a pod. In their own little world and detached from reality.
The CEO stated he would ask Nasdaq to halt trading for the AdCom.
The other thing going on is that some keep posting things like when briefing documents are released it is likely to create a "Significant drop in price". It may, and it may not. It will depend on the documents, but those trying to create doubt are not going to tell you that.
Who says it wasn't emphasized until now? Those who were paying attention understood it all along. If you have been paying attention to all fo Dr. Bhatt's talks this is not the first time it has been discussed.
These media outlets need to try and create controversy to drum up interest and suspense. That is what they are doing now. Institutional owners still want your shares. They are still trying to get those that do not understand statistics to sell their shares because they want them. That is what they are doing now.
The video link was posted on twitter when it was live. Many watched it there before the link ever made it over here. I hate to tell you this because I know you will have trouble with it but InvestorsHub is not the center of the universe.
I care about the long term so good results are good results. We are going higher.
IMO, Amarin already having the 4:30 Investor call set up for November 18th is a total telegraph.
Everyone needs to remember the AdCom is just an advisory committee. Even if the AdCom members do not know about Evaporate results by the time of the AdCom, the FDA will know by the time they finalize the label by the PDUFA date, December 28th. It may lead to temporary uncertainty for some. It may make sense to have a few dollars ready to invest in any drop based on the uncertainty surrounding the AdCom. Short interest is clearly trying to promote this uncertainty. They will be ready to take it down temporarily. It is just going to be a battle for who has the stronger conviction. IMO, Evaporate results right after the AdCom should give us longs the stronger conviction. Yes, MO will be mentioned in the briefing documents and Amarin has all the detail and is ready for this discussion. Take advantage of any drop.
I thought all of his fees were directed to his employer, the Cleveland Clinic. It is a is non-profit organization but I wouldn't call it a charity.
It looks like the duration is six months because physicians want to see you back in their office to do blood work when you have cholesterol/triglyceride issues.
$51 price target. H.C. Wainwright sees 'positive momentum' for Amarin into Vascepa FDA panel meeting $AMRN http://dlvr.it/RHkg4H
Adam F. Did not say he had the briefing documents. BS.
this same guy CGB3 Beck @princetongb has tweeted a few things incorrectly recently. His last one was trying to say that the last Form 4 was a stock sale instead of an JL converting options into shares. If past history is any indication, he will block people and then eventually delete his incorrect tweets. He was short AMRN for a while but currently claims to be long.
That hasn't happened. Amarin has stated they have responded timely to all responses. It would be material if they refused to comply. Do you really think Amarin would be hiring 190 people if that was the case?
New article on DHA crossing the blood brain barrier. https://www.sciencedirect.com/science/article/abs/pii/S0955286319304206
I think you are right, we should fight back a little on this. Nissen is the lead investigator on a trial using corn oil, an Omega 6 yet he can come out and say negative things about an inert mineral oil. I don't think you need to just look for issues with placebo corn oil, but corn oil in general.
Corn oil has an omega-6 to omega-3 ratio of 46:1, which can contribute to this imbalance (1). Summary Corn oil is 100% fat and provides 122 calories per tablespoon (15 ml). It's mostly made of polyunsaturated omega-6 fats and contains some vitamin E.
"That's really the only reason to treat TGs >500 in patients without CVD. "
Wow, what makes you the authority? Did reduce-it not teach you anything?
It is an older article but the discussion about corn oil is very relevant to the Strength trial.