Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Sorry I started all this, LOL I am just very glad that people share their DD.
Amarin is going after all patients who are taking a statin. HLS said they were going after the same indication and they have stated their indication is all patients on statins.
They both could have helped people in different ways. It is an opinion. Depending on what type of help a poster needed both could have contributed. I have followed John on twitter for years which helped me keep an eye on $AMRN. From what I could tell, John posted everything that was being published regarding EPA and DHA. He posted things whether they were good or bad for Amarin. I did periodic reviews of the journals and was ready to buy back in big before Reduce-it. I guess it may all depend on where people were looking for information. It does not have to be either/or. You have to know what you own. If you don't know what you own and trust your own judgement you can make mistakes just relying on one poster.
That quote is almost a month old. Based on time lag and the information that has passed back and forth since then, I would think his %'s have changed at this point.
I am okay with that. I personally want to have access to all the information available and process it on my own. That is the way I learn and I can always ask questions if it is over my head. I read everyone, and I do not put people on ignore. I want to see and process it all, even those that are looney toons.
I think the IL-10 information is interesting in this. EPA raises IL-10, DHA lowers it. tumors. I like my EPA.
He post useful information that I do not see elsewhere. We are not all perfect and we need to make our own judgements based on all available information.
I would imagine that some of these jobs will never be posted. It was just the end of the year where they went through the hiring process. I can see them calling up candidates that have already been interviewed and confirming they are still interested. I think the process will move along pretty fast this time around.
Here is something more recent courtesy of John Cappello on Twitter. Everyone should be following him by the way.
?
@JohnCappello
Jun 25
While DHA inhibits a broad range of pro- and anti-inflammatory cytokines, EPA has a relatively minor role in lowering pro-inflammatory cytokines but preserves the anti-inflammatory IL-10. DHA, but not EPA, increases LDL-cholesterol.
https://www.ncbi.nlm.nih.gov/pubmed/31225033
Though the FDA generally tries to adhere to PDUFA dates, they aren't set in stone, and it's not unheard of for the FDA to extend a PDUFA date. This generally happens when the FDA needs more time to complete the review process.
You might want to find the more recent study.
Do you have a link for that?
I see that was a bad example. I still think an early approval is a real possibility. This Friday, June 28th is the scheduled mid cycle review meeting. Amarin should be laser focused on that the rest of this week. If they successfully get the FDA everything else they are looking for, good things will happen.
"As set forth in guidance issued pursuant to Section III(A)(1), the Project Manager and other appropriate members of the FDA review team will call the applicant to provide the applicant with an update on the status of the review of their application. An agenda will be sent to the applicant prior to the mid- review-cycle meeting. The Project Manager will coordinate the specific date and time of the telephone call with the applicant. "
Thank you for a great summary.
It really think is totally crazy for anyone to think that suddenly these companies and this Judge are going to override all of Amarin's patents. If there was any chance of that TEVA would not have settled and GSK would have fought Amarin and epanova would be on the market right now. The judge allowing Reduce-it results into the court room is a big tell. Amarin has that much more evidence on their side now.
You can look on Hikma's website and see that they don't win trials and invalidate patents. They settle for generic launches out in the future. When patents expire.
This ongoing discussion is just an excuse from others to try and steal our shares. John says he likes our IP and he would not say that if there were any doubt in his mind with current trial. We gave TEVA 2 million bucks to go away. If we have to give these other companies 4 million bucks who cares. They will happily walk away and be back in 2029 or 2030.
Nice, so if Vascepa followed same timeframe with Priority review, the Sept 28th PDUFA date could tern into a July 28th approval date. I would be okay with that.
Short interest down slightly. Someone is losing their conviction.
Settlement Date Short Interest Avg Daily Share Volume Days To Cover
6/14/2019 25,242,508 4,638,075 5.442454
5/31/2019 26,542,109 6,245,726 4.249644
5/15/2019 25,577,533 5,083,965 5.031021
4/30/2019 23,732,579 5,442,797 4.360365
4/15/2019 21,911,936 5,652,460 3.876531
3/29/2019 21,149,076 10,714,138 1.973941
3/15/2019 16,859,967 8,086,743 2.084890
2/28/2019 17,514,524 10,037,142 1.744971
Link to 11:20 BMO Capital markets presentation. https://event.webcasts.com/viewer/event.jsp?ei=1249014&tp_key=47658a5b24
This is how the slide is worded. I can't get the audio to play right now to let you know the wording but If I am remembering correctly he said no triglyceride threshold
Prospective indication for CANADA:
• For all statin-treated patients being managed for CV
prevention, VASCEPA is the first and only therapy that significantly reduces the residual risk of CV events and death
Right above that quote it say -
Supply capacity expanding
So they are not sitting waiting. If you look at the balance sheet you will see that have millions of dollars worth of finished goods and there were big increases from 12/31 to 3/31.
The answer is none. Listen to the HLS presentation. They stated they asked for the same indication in Canada that they asked for in the US.
That difference in IL-10 really sticks out. DHA is bad. EPA is good.
Slides for todays presentation.
https://investor.amarincorp.com/static-files/42250e50-acf0-4628-8104-1bdf461f5aa4
Good question. From what I have seen in the past, it is not part of the normal process for the FDA to let the company know this early that there would be no ADCOM. I have never seen a company PR that they will not be having a ADCOM. The FDA and the company hold the possibility open in case something comes up during the review of the application. If something does come up during the review, the FDA informs the company of the ADCOM. If the timing is later in the cycle, they just delay the PDUFA date so the company still has proper time to prepare for the ADCOM.
The FDA requires all diabetes drugs to run outcomes trials. This one clearly worked out better than most.
This drug is made to lower blood sugar. I do not see it as a competitor. Reduce-it protocol was for Vascepa to be taken on top of diabetes medication in diabetics. Vascepa would reduce risk above and beyond what this drug would do. It is likely there were people in the Reduce-it trial that would have been on this drug or similar drugs.
Pretty common name. Not related.
MRC confirmed two of the members on their twitter feed.
Medical Research Collaborative, LLC
?
@MedResCol
Follow Follow @MedResCol
More
Replying to @DLenzn1 @SharonAConklin
James Murphy and Steven Giardino. However, we will not confirm any details about them.
10:39 AM - 5 Jun 2019
Update: ConnectiveRX responded to SecurityWeek, denying that the database belonged to the company. “The database referenced in the recent media article is not a database that we maintain or even have access to. We don’t use that database management system at all for any of our programs,” David Yakimischak, CTO at ConnectiveRx, said.
Weekend listening, for those who have not had time. There are some good tidbits here regarding milestones and what he believes the US market will be.
$AMRN Canadian partner for Vascepa, HLS Therapeutics President & Chief Operating Officer Gilbert Godin present at Raymond James Life Sciences and MedTech Conference
http://wsw.com/webcast/rj115/hls.v/ …
The slides can be found here - http://hlstherapeutics.investorroom.com/events
Know what you own!
As of June 21, 2019 2:00 pm EST:
"We still have not been apprised by the FDA as to whether or not we will have an adcom"
This is consistent with the Goldman quote that they have not heard one way or the other if there will be an adcom.
It is pretty clear, everyone is in agreement that Amarin has not heard whether there will be an Adcom except for MRC. I hope he didn't quit his day job.
If I am reading this correctly, that was the way it was since 2004. Now the FDA is requiring them to add the disclaimer.
I think people get too hung up on the week to week instead of the month to month. If you look back a month (which would be the last time these scripts would have been filled), scripts are up considerably.
You would need to multiply it by 12 because the script number is only for a one month script. Those 100 million people would be getting 12 scripts.
Price targets from analysts are not a price target for a buyout. Unless stated otherwise they are generally a target for one year from when the price target is issued. Price targets from analyst are for a stand alone entity.
$AMRN What is Amarin’s view on the June 19, 2019 CFSAN evaluation of proposed qualified health claims applicable to food and dietary supplement products containing the omega-3 acids? (link: https://investor.amarincorp.com/static-files/39ef105f-f065-4f55-8aec-8eb5432b4c5a)
thanks to Greenday on Twitter
What is the saying about no bad press. Part of this security release -
"The medication is unique in that it lowers triglycerides without raising a patient’s LDL, or bad cholesterol. Vascepa stands out from other Omega-3 supplements in its lack of DHA, an Omega-3 fatty acid which has been shown to raise LDL. It is only available with a prescription."
You probably should have actually listened to what the company has said since they would have received the 74 day letter. You need to retract the other part as well. From June 12th - "Again, we’ve heard neither yay nor nay on that topic that will silence at this point time and again that’s not surprising."
Your experts clearly need to read and understand SEC regulations instead of just making this up as you go.
It is all part of the only IP case remaining. Markman is just a name for one part of the process.