[rosemountbomber]

Thanks Sleven. Good write-up on Vazkepa.

[Number sleven]

https://www.larazon.es/salud/nuevo-farmaco-pacientes-alto-riesgo-cardiovascular_202310016518b5121fb4a600013dd3e5.html
Sleven,

[ramfan60]

jasbg, outstanding find.

[Number sleven]

JRoon, No problem. I check the site several times a week.
Sleven,

[JRoon71]

Thanks for this, North.

[JRoon71]

Thanks!

[jasbg]

Weekend !
---------------------

Every day for more than 10 years on the road as a IT field engenier for NCR in Denmark - I listened, at least once in the car, to the org Dire Straight version of - Brothers in Arms - the music of my life 🙂

So I fell upon this fabolous guitar version here lately:

------------------------------

First time I listened to the number were in underlying music in - the at the time - very big Miami Vice series 🙂

[lizzy241]

Tal, Thanks for this amazing data. Unfortunately, I don't think this will move the needle for the price of the stock. Just another reason why everyone should be inhaling Vascepa.🙂

[mrmainstreet]

What is the potential impact to this on scripts? Seems like positive news.

[TalShu]

Ziploc

Thanks for correcting me in a subtle way.
It's Patent Cooperation Treaty.

[Number sleven]

Zip,
https://www.drugs.com/monograph/icosapent-ethyl.html
Scroll down to the section on absorption.
Sleven,

[jasbg]

Many 'did research' before Proxy vote (reason Denner and Sarissa - got +100 mill blue votes - winning BIG) 🙂

The guy is a genius in what he does - simple as that ✌️

[ziploc_1]

Tal...Thank you for this very interesting article, in which you summarize a 232 page article from the PCT( Patent Cooperation Treaty), dealing with an EPA patent application on an enhanced lymph releasing composition of EPA from Amarin.... I am really interested in this article, especially in the part that deals with the significantly enhanced delivery of LR-EtEPA to the lymph nodes with the possibility of potential benefit to Lymphoma cancer patients.

[TalShu]

Lizzy,

See my post 414421: Ziploc,

EXECUTIVE SUMMARY

Based on 9 U.S. Provisional Patent Applications, Amarin has secured a worldwide patent priority claim to a lymph-releasing composition of eicosapentaenoic acid ethyl ester (LR-EtEPA) technology/invention and methods of using the same to increase EPA uptake in tissues to treat and/or prevent the onset of a number of diseases including:

- Cardiopulmonary, cardiovascular, and cerebrovascular diseases
- Pulmonary disease including sepsis, SIRS, and/or ARDS
- Neurological diseases
- Cancer
- Diseases associated with the kidneys, pancreas, liver, intestines, blood cells, lymph, and the musculoskeletal system
- Diseases associated with oxidative stress and/or glutathione (GSH) depletion
- Inflammation and diseases induced by air pollution
ETC.......

[lizzy241]

Tal, Once again you have posted another articulate message regarding the unknown AD tidbits. Actually, I'm shocked that others who have been on this board for many years didn't research Denner's success stories. It has been mentioned in many articles the level of his intelligence is unusually high.
On another note, the patent approval process of 22 months you reference would it happen to be for MND-2119?

[Jvee]

From Stocktwits:

http://stocktwits.com/DoMoreCharity/message/546320264

[TalShu]

Couldbebetter

Two remarks, if I may:

First:

According to USPTO historical records, it takes on AVERAGE 22 months for PTO to grant a patent related to the pharmaceutical industry.

Amarin registered its first provisional patent application for LR-EtEPA on 26 January 2022. This is the date that counts for giving Amarin US patent priority claim.

According to USPTO rules a final so-called non-provisional application must be made within the 12-month non-extendable pendency period in order to preserve the validity of the initial priority claim date (26.01.2022).

In the absence of any official/non-official information in this regard, we assume this must have been done because Amarin applied for an International Patent Protection (IPT) for LR-EtEPA on 26 January 2023 based on all non-provisional US patent applications. Were the latter not valid the World Intellectual Property Organization (WIPO), which manages IPT, would not have been able to notify the 157 contracting States of Amarin’s application on 03 August 2023.

20 months have thus elapsed since US patent priority claim was established.


The above facts may explain why KM anticipated, in November 2022, announcing a significant update on FDC by the end of H2023! There indeed remain 2 months to reach the AVERAGE 22 months for USPTO pharmaceutical patent approval.

Hope such an event occurring in the next six months would constitute an important catalyst in Amarin’s life.

Secondly:

A. From TD COWEN PODCAST:

Yaron Werber:
Yeah. We’re going to move to my favorite part of the podcast. It’s a little personal touch and humor…. tell us one thing about you that no one knows. And it’s totally a secret, we’ll just keep it between the three of us.

Alex Denner:
Yeah. Well, I was going to just mention… Maybe this is a little bit more boring, but I love chemistry and I have kind of a home chemistry lab. I mean, nuclear engineering, chemistry, I spend a lot of time sort of, not related to experiments, not related to creating therapeutics, but I collect elements and I just find kind of elements in chemistry itself quite interesting. In our office… And both of you are welcome to come, and others I think have seen it, although it just got installed not that long before the pandemic, so maybe it is a secret. But we got a big periodic table, a large, large periodic table that’s actually made of… We have a cube that’s about so big of acrylic, and inside we have a sample of the element.

B. FROM Fierce Biotech:

Combining knowledge of the business with a clear connection to the science involved

Denner has created the template for the modern-day biotech turnaround story.

“Alex actually understands the science–and how to build that into a business,” ex-con and ImClone founder Sam Waksal told Bloomberg. “When a company is broken, he knows what should be done to fix it.”

As an inside player, few can compare to Denner. The big question now is where he plans to play next. And who will follow his game book on their own deals?

Article Written by John Carrol – Fierce Biotech
To read the entire list of the Most Influential People in Biopharama Visit Fierce Biotech

Best Regards.

[Laurent Maldague]

Thanks for article Kiwi.

"The researchers said this may help explain why people who have underlying plaque buildup and then get COVID-19 may have cardiovascular complications long after getting the infection."

I suspect the primary endpoint in MITIGATE may have been too restrictive, but that's where the CVD endpoints serve as a catch all. If a patient contracts Covid, develops moderate symptoms but not enough to go to the hospital and "recovers", but two weeks later is hospitalized for an MI or stroke, that outcome would not count towards the primary endpoint, but is counted in the exploratory CVD endpoints. That to me is the x-factor in MITIGATE, that perhaps we see a slightly stronger than usual MACE risk reduction due to Covid manifesting itself in the CVD endpoints.

Regarding AHA 2023, seems like their marquee exhibit is the SELECT trial (Ozempic), presented by Abraham Lincolf (Cleveland Clinic, he was also a STRENGH trial investigator). Lo and behold, Steve Nissen himself is presenting a late breaker in LBS06, "Future of Lipid Lowering Therapy", where Pam Taub is a moderator (she was the discussant for RESPECT EPA last year), and where MITIGATE would most likely have been slotted if it was submitted at all.

Technically, LBS06 is not finalized. There's one trial that hasn't confirmed yet, but I have no idea if AHA has plans to slot in a replacement.

[lizzy241]

Capt, as you know Denner is beyond qualified in chemistry. He knows the value of Vazkepa. Stay tuned.

[CaptBeer]

I beg to differ he received his BS In Biotechnology at MIT, MBA at Yale and PhD in chemistry at Yale

[dogn]

deleted

[had posted MND-2119 paper https://doi.org/10.5551/jat.64135 that appeared new but was posted here previously in early August]

[noelan_s09]

Denner is not a science guy? You may want to research him.

Noel

[couldbebetter]

JRoon71, ??? I never said anything about secret trials.
I said that AMRN may keep secret their drug development
of any new version of an EPA drug. Denner is a "science
guy" as he has an undergraduate degree from MIT & an
advanced degree & doctorate from Yale. You seem to
intentionally miss my point which is simply that Alex Denner
may want to interest BP in AMRN not only on the basis of
Vascepa but also for the prospects of whatever AMRN may
have in drug development. Not that AMRN would be conducting
any new trials for any new drug, but certainly explain to BP
what the potential of any new drug (or delivery system for EPA)
could be for a BP.

[Whalatane]

Laurent. Thought this might interest you
https://www.nih.gov/news-events/news-releases/sars-cov-2-infects-coronary-arteries-increases-plaque-inflammation

https://www.nature.com/articles/s44161-023-00336-5

Study was done on the early Covid strains ...may not apply as much to the Omicron strain that was prevalent during most of the MITIGATE trial
Kiwi

[north40000]

Scientists discover how brain cells die in Alzheimer’s

https://www.msn.com/en-us/news/world/scientists-discover-how-brain-cells-die-in-alzheimer-s/ar-AA1gKGni

Scientists in the UK and Belgium think they have figured out how brain cells die in Alzheimer's disease…

But the team, writing in the journal Science, connect the abnormal proteins that build up in the brain with "necroptosis" - a form of cellular suicide…

They say abnormal amyloid starts to build up in the spaces between neurons, leading to brain inflammation, which the neurons do not like. This starts to change their internal chemistry.

Tangles of tau appear and the brain cells start producing a specific molecule (it's called MEG3) that triggers death by necroptosis. Necroptosis is one of the methods our bodies normally use to purge unwanted cells as fresh ones are made.

The brain cells survived when the team were able to block MEG3.

…The answers came from experiments where human brain cells were transplanted into the brains of genetically modified mice. The animals were programmed to produce large quantities of abnormal amyloid.

There has been recent success in developing drugs that strip amyloid out of the brain and they mark the first treatments to slow the destruction of brain cells.
[Will the continuation of the Brave study at U. Wisconsin illustrate that Vascepa has been or can be used to treat Alzheimer's Disease and its biomarkers per the above or similar paradigm?]


https://www.science.org/doi/10.1126/science.abp9556

***********************************************

The above is from Biowatch on the BioTech Values board a few day ago. I added the question in [...].

[seve333]

Pretty sure Denner did not take over the company because of Brave. Sure it would be nice if it was positive but knowing this stock who even knows if it would move up much to be honest. Revenues is the bottom for this stock period.

[DAR53]

JRoon, it certainly seems to me that prior management failed us. Now as far as Denner, I concur that the jury is still out. It has been quiet and we can only speculate that Denner's statement that Amarin was undervalued is true and the SP begins to improve.
I have too much invested to walk away from it at this point.
GLTA longs.

[seve333]

How would they even know anything about Brave I thought it was an independent study being done by University of Wisconsin?

[Number sleven]

JRoon,
https://clinicaltrials.gov/search?term=Vascepa
This is a list of all the clinical trials run on Vascepa.
Sleven,

[JRoon71]

Sleven, I've looked at them before, but did not keep the links. If you have them handy, that's great. But no need to go digging.

Thanks-

[JRoon71]

What are they going to say about BRAVE? And why would they say anything if they don't know the outcome? It seems that this would be counter-productive for them to talk about, if it ends up being a nothing-burger (which I'm not saying it will be, just saying that talking about it without results seems foolhardy).

[JRoon71]

Has current management shown that they are doing materially more for Amarin than prior management?

Honestly, I'm not saying they aren't doing anything. I'm sure they are. But just like prior management, they are doing it without saying much. At least, that's about all we can surmise from what we have seen.

But all this "Denner is taking us to the Promised Land!", and "prior management did nothing" seems a bit disingenuous - until Denner proves otherwise.

[DAR53]

JRoon, the difference in my opinion is that prior management couldn't find their ass when blindfolded. They did little to fight generics infringement. They should have under JT, join the Marjac case to provide standing. They should have this, they should have that;;; But they didn't!!! Water under the bridge.
Hopefully AD and the new board will be proactive to take steps necessary to open all opportunities and get this sold to BP.
JMO

[Denisk]

Exactly. How many times have you heard from Amarin about the Brave study? None

[Number sleven]

JRoon, From memory, there are 4 clinical cancer trials being conducted with Vascepa. I can post the other 3 for you if you like.
Sleven,

[JRoon71]

Exactly, which is why I said it would be "years away" (if the outcome is even positive).

[JRoon71]

Well, sure. But that knowledge is not something that was specific to Denner. He's not a science guy, he's a hedge fund manager. Point is, Denner is not doing anything that was not already in the works. And any cancer trial outcomes are nothing more than long-term speculation at this point (the one that we know of is at least 3 years away from completion).

And maybe I'm wrong, but I don't know that they do clinical trials "in secret" (on humans, anyway).

[Number sleven]

????

[ziploc_1]

Have a fever?...Take an Aspirin...Then have your Doc tell you about the other specific meds you should take....as well as the number of Aspirins you should take.

Have cancer?...Take EPA...Then have your Doc tell you about the other specific meds you should take...as well as the number of EPA capsules you should take.

[Number sleven]

JRoon, My point was that we don't need to speculate about which Cancers would be studied or how long it will take. We already have the information.
Sleven,

[couldbebetter]

JRoon71, If Denner knows as much as you about the "prospect" of using a "new patentable form"
of EPA as an adjunct drug for better outcomes (not a cure) for Cancer patients, then I think he would
want to use that to entice BP into making a bid. If BP is interested in Vazkepa as a CVD drug in Europe
they could have exclusivity there until 2029 (according to Holt.) That by itself has a value for a BP as it
is 15 years of sales. What I am suggesting regarding EPA as an adjunct Cancer drug is something a BP
could work on by conducting several proof of concept studies (which is what BRAVE is.) BP will not do
such studies unless they had a version of Vascepa that could be patent protected. MY POINT IS THAT
IF SUCH A VERSION IS BEING DEVELOPED by AMRN, perhaps in secret for now, then BP might be
interested. As an example, MRK has done hundreds of trials with their cancer drug Keytruda. If AMRN
had a patentable version of Vascepa for the future a company such as MRK might want to do a few proof
of concept studies with it and Keytruda. Put another way, this concept might be a way to interest BP in
buying AMRN not just for Vascepa sales, but something potentially more lucrative in the far future.

[CaptBeer]

@Aifa_ufficiale DYK CVD costs to EU members exceed €281 billion/year? Italy is amongst the highest in per capita costs (€726). CVD is the leading cause of death in the Big-5 & Italy is 2nd behind Germany (236,507). You can REDUCE-IT (-20%, p=0.03) with VAZKEPA® (IPE)! pic.twitter.com/NPRfbySq2w

— Mike Everts (@GeoWizz_) September 23, 2023

[JRoon71]

Lizzy, that, or someone like Feurstein or Nissen dropped a dime to alert the PRAC about the risks of AF with IPE use.

[JRoon71]

Thanks Sleven. I am familiar with the study, but that is still 3 years away from completion. So 4+ years from being commercialized.

I can't imagine still sitting here 3+ years from now waiting for results of this as an AMRN investor.

[Number sleven]

JRoon,
https://clinicaltrials.gov/study/NCT05198843?term=Vascepa&page=2&rank=16
Sleven,