Today is pretty damn good volume for semi holiday type of trading day.  Most stocks are at average or below volume today.  We shall take it.   Hope 2025 is a much better year for all of us here.  

Yes, but the point JRoon was making that they might undercut the Generics and basically lock them out.  That is not happening now as Amarin is losing scripts to the Generics.  If they were currently cheaper than Generics, as you suggest why are PBMs choosing GV over V.  Doubt it is because they are willing to pay more for GV 

Do we know if they have actually started the approval process with the FDA? Isn't that material information that they would need to release?

Also, I like the idea you posit of undercutting the Generics on price, but will Amarin be able to do it, and would they be losing money doing so?

Yes, after reading your post I pulled up a 1 minute interval chart and see those you mention. There was also a bit of a volume spike somewhere just after 9:45 +-.

Looking forward to getting into the New Year and at removing the tax loss component from the equation.

Quite a sea of red this morning.  

My question was based on the idea (mentioned on this board), that this new formulation would only be required to show bioequivalence.  I have no idea whether that is all that the FDA would require.  

Ram, first congrats are in order for your Rams.   Then in that little equality thing, what if:

A = new formulation
B = Vascepa
C = Generic V

Although we know it would be illegal since it would be violating patents (doesn't seem to be stopping them now) what would stop them from stealing from A?  Yes, I realize A would require less pills, but to save money these actors would stoop to anything.  Now maybe the salvation is that the new formulation is supposed to cost less to manufacture.  But they would have to use that cost advantage and compete on price with these Generics.  

I am guessing that this may be a stupid question but here goes anyway.

If A is shown to be bioequivalent to B, and C has been shown to be bioequivalent to B, then does it follow that C is bioequivalent to A?

Good little (a little longer than little) article outlining prospects for RZLT. Seems promising:

https://biotenic.substack.com/p/rzlt-long-ph3-sunrize-data-2h-2025?r=5xh7t

Another good showing today by ARDX whilst many stocks got hammered today.  Good sign. Mott keeps buying - another hood sign. 

Checking around the web it seems most want over $3K for the full report. You are correct about the projected growth percentages, but of course small increases from a small base can yield high looking percentages. The growth in absolute numbers will still be greatest here, but I agree it would be nice to see the full report.

Thanks for posting Sleven. Too bad a lot of this growth being projected is being stolen by the Generics.

What is driving UNCY and ARDX higher today?

Not a doc here and not giving any advice but it means that when the heart is full that it pumps 79% of the blood out to the body. Some consider that number a bit high but see what cardio doc says. 

Hilarious.  Just put in plaque stabilization in google and fifth entry in results has IPE and Evaporate listed there.  These researchers seemed to be trying to not find all the data Mason and others developed.  

Thanks.  Was hoping we could get something to confirm or dismiss claims here that Sarissa is shorting. 

If I am reading this correctly we should find out on Jan 17 or shortly thereafter if Sarissa or any other institutions are shorting our stock above the specified threshold. 

Do you think data for NSCLC is far behind?  Pancreatic cancer is a bitch, and I think NSCLC offers more hope for success. 

No question PBM is a heavyweight in small biotech investing. And of course as you mention Paul Manning who leads them is on the board at Candel and just sank a bunch of money into buying shares personally it seems.

For those who are not that familiar with CADL, this short talk with CEO Tak is a good primer:

If I had to pick a couple of things that were the least positive in that talk, I would say these would be it:
1) Around 5:40 mark, Tak talking about some clinical trial results are coming in the next qtr and "if several of these are positive".... - tough enough to have one study meet endpoints, so hoping for several positive results adds just a bit more anxiety to this. But hopefully past data dictates hope might be justified.
2) Although Tak mentions the path forward will probably involved BP in the form of partnerships, he seems to leave the U.S. market for CADL alone and talks about turning the company into a small Pharma. Although he worked for GSK and recognizes how BP has a much greater ability to drive sales, his mentioning of keeping the US for himself sends up red flags for me about GIA. I have seen that happen to so many small bios. Egos eventually doom the path forward.

Will be watching this closely.

Thanks for posting.  Well we made it into the top 10 Journals scans for the year.  I assume it was not because of Amarinians' views.  

The study does mention and reference Reduce-It, but icosapent ethyl is the only nomenclature used.  Sure some clinicians who dig into the study will come across "Vascepa" but I guess so many will write IPE as the script.  Or, of course, as we have seen, if they write a script for Vascepa it will be turned down by the inurance company or switched st the pharmacy.  

Let's hope we can gain more traction in the EU in 2025 and have some positive developments during discovery phase of the legal front here stateside.  

Wishing everyone here a Merry Christmas, and somehow, hopefully, a healthy and Prosperous New Year. It seems crazy when you think about it, but I a feeling of family and camaraderie when I think about this board. I guess being here for so many years does that. Thanks to all who post here as much of it is valuable to the rest of us.

If only it were the practioners that were paying for it.  

I notice that an old nemesis (in another stock years ago) Adam Feuerstein seems to be mostly bashing CADL. Not sure what his deal is. He has attacked CADL in relation to a lung cancer trial since it was not placebo controlled. But not really sure what his problem is here with prostate cancer.

I will say that there seems to be one point that he may have and that I find confusing myself. If anyone can better explain this one top line bullet point in the press release I would appreciate it:

Operator
05/09/2024 at 06:17 PM
This is a common misconception that this strip is common area, but it is actually a part of your lot and needs to be maintained the same as your lawn. No worries though, we are only recently sending out letters/citations about landscape maintenance so you do not need to worry about being fined in the meantime. For reference, it takes close to two months for us to issue fines following the initial citation, so you have plenty of time to make arrangements to accommodate this.

"14.5% relative improvement in DFS observed at 54 months for the CAN-2409 treatment arm compared to the placebo control arm"

I am not sure exactly what they are saying. I know AF also questions why specifically the 54 months. TIA

Someone here earlier today likened the situation there with that of Spain's. I know they have 35 people already to go to try to drum up sales. It would be nice if we got an uptake there close to that seen in Spain.

Do they keep an ongoing tally of the cost of the scripts and do they stop reimbursing if they reach this predetermined budget limit?

I used to think that being separated from almost all the countries in the world by 2 great oceans was so good.  For a long time it was good in terms of protection from invasion.  On the other hand if we were in the middle somewhere surrounded by dozens of countries ( like Europe) we would have more easily seen how other countries do it and not tolerate the ridiculous healthcare system we have.  

Yes, there seems to be an endless supply of formularies that CVS Caremark pushes out. I checked out a few online and the vast majority do not cover Vascepa at all, but the Medicare plans usually do.

Found this on one of their websites explaining how they operate:

https://business.caremark.com/insights/2024/2025-cvs-caremark-formulary-updates.html

Good questions Sleven. 

North, the answer to your question I guess depends on whether you are filing a joint return. From Publication 550 in the section about capital losses:

Yep, I can vouch for your heads up on CADL.  Had to do some reshuffling in a porfolio but picked up shares yesterday when I stopped in a rest area when driving back from Vancouver.  When I saw what it did today I regretted not jettisoning everything in the portfolio and dumping it all onto CADL.  TY 

JRoon, I find it interesting or rather worrying, that this miraculous AI would spit out information that seems to be very difficult to find and confirm (talking about patent challenges in the EU).

But I eventually found this that confirms it to some degree without exactly specifying the challengers:

https://www.biospace.com/amarin-provides-update-on-vazkepa-icosapent-ethyl-intellectual-property-portfolio-in-europecompany-s-ip-protection-for-vazkepa-in-europe-now-extended-into-2039

We have to remember that third parties don't have a Marine loophole to use to try to steal scripts in Europe as Vazkepa is not approved for the Marine indication there. So I guess the only way would be for them to try to attack the CVD patents.

Hope it works out. Good luck to you and all the rest of us long suffering longs.

I know that this is not totally analogous but here the FDA clamping down on unapproved knockoffs fairly quickly (I guess because they are protecting Big Pharma), but are doing or saying nothing about Generic IPE being sold for unapproved indications:

https://finance.yahoo.com/news/fda-finalizes-decision-to-end-lillys-glp-1-shortage-analysts-predict-novo-will-be-next-205707919.html

Triple avg volume so far today with an hour left.  

Thanks Chevelle, that was good and supportive to the stock, but I am still surprised how well UNCY has held up with the realization that the KPA is probably not passing. Seems to have hurt ARDX much more.

So I guess here is a focus on the future.
1) Legal front to cure US scripts being taken by Generics -- years and years from now with prognosis slim for success. And as for settlements, HealthNet a good example of it not helping at all.
2) EU sales - slow as molasses. Can something happen to pick up that pace?
3) Share BB. Company seems very reticent to initiate and as others have pointed out the rules surrounding amount that can be purchased per day means that it would take a long time to purchase anywhere near the authorization limit.
4) RS - lowers our share count and raises the stock price - for a couple of days - maybe.

If anyone has other possibilities please post.

He may not have been the only with some culpability, but he definitely did not perform his fiduciary duty as CEO for a one drug product company. I obviously deserve much blame for not jettisoning more of this investment earlier. After the drop to 4 bucks I bought the arguments that the EU was being massively under appreciated by the market and analysts, and that was a huge mistake. I believe there are a number of posters here like myself that would give an eye tooth to be able to unload everything at $4 today.

I guess I should add that I calculated the Generics taking the scripts for Marine only and didn't use my head and what I already knew when it came to scripts that ultimately the corrupt system we have would eventually eat even all the CVD scripts here in the U.S.

KNJS, I had been making the same comment about the 3K ad infinitum, but after reading yours, I decided to look up something I had never checked.

We will get screwed even after we die. If you are married and your losses are in a joint account, then after you die, your spouse can try to use them up in the final joint return (year of your death), but thereafter she would only have 50% of the remaining losses.

If you have the cap gain carryover losses in an individual account, again the beneficiary can use as much as possible for your final return but then after that it goes to zilch.

Instead of this going to zero, how much would we get if they closed up shop and distributed all their cash to the shareholders?

Yes, it was Singer that I was thinking of, thanks.  And, yes, the Marjac effort was outstanding.  So memorable listening to the arguments he presented in such a logical, cogent, and eloquent way.  It was riveting to listen to.  The company by not joining the effort gave the judges their only way out.  

Big insider purchase 2 days ago:

https://www.secform4.com/filings/1841387/0000950170-24-137889.htm