That is a tight division. AZ has 6 wins and everyone else 5. If the Seahawks win then they will be tied with both at 6-5. If AZ wins they open up a bit of a lead.

Not sure but it has bounced back from the Nov 5 lows. Chart looks like more upward movement expected and of course we are expecting FDA decision before the end of the year. It does seem like with their cash position and wherewithal that they would want to license the drug to BP or sell entirely to BP and have seen a poster on ST suggest the company has stated that they would be looking for such, but I can't find those statements from the company on their website. If you are aware of their intention to partner or sell the drug or themselves I would appreciate a link.

Just my opinion, but if we rally into the decision and even if it is positive I think the stock would sell off if no news on some kind of a deal.

Not sure that is our problem as I am not aware of that CVD patent being invalidated in the near future.  Ours is a different problem where the "system" is purposely and inadvertently infringing on that CVD patent. 

I guess many of us here have mostly focused on Italy and France as far as reimbursements go, and basically have pushed the possibility of German reimbursement way to the back of the line.  Read a story about how Bosch will be forcing their workers into a 4 day week citing a deteriorating economy.  Not sure if that is specific to the auto parts industry or more widespread but it could push German reimbursement for Vazkepa even further back in that line.  

My hope is that we get Italy now and France sometime in 2025, and if somehow Amarin can get scripts moving in the EU that at some point the Germans will look around and see V available and selling well and decide it is time for them to join the bandwagon. Not sure how stubborn the Germans are though.  

https://finance.yahoo.com/news/german-giant-bosch-becomes-latest-144357326.html

And, at my advanced age, that is why I still change my own oil.  

Yes, you are correct and I believe what you are referencing is the delivery system, i.e. in our case the patent capsule design which makes a big difference.  

Do you think, assuming the Kidney Act, that there would be less of a reaction in UNCY's stock price compared to ARDX's since UNCY won't receive approval for another 6 months or so?

Nuke you are right about cost being the issue. I think Germany has basically alluded to that in a roundabout way by referring benefit/cost ratio. 

As an investor here, I fully support your efforts in that regard since it would help our situation here.  Unfortunately as a chemist, I wouldn't agree. A drug being shown to be the same or equivalent to another has nothing to do with what indication it is used for. 

You are good Kiwi.  I saw the letter on ST yesterday but couldn't either get a link for it or copy it to post.  Unfortunately it seems that Congress won't be back working until the first week in Dec and not sure if they will get this done.  As you may recall I am also waiting for the Senate to act on another piece of legislation I am interested in (SS Fairness Act), so pins and needles till the end of the year.  This letter impressed me and if it does not stir those senators to act, I am not sure what will.  Worrying as well that as I am waiting for some of these bios to pay off the general market one of these days is due for a dump - and take all these with it.  Looking to find good exit points on all these by Spring at the latest and hope it is not too late. 

Thanks Capt. I guess to some degree it doesn't matter much since V is an approved drug and so forth. Not sure how much micro managing the head of the FDA would get involved in when it comes to the new formulation. I guess they have set rules they follow.

I find it interesting in a philosophical context that the FDA does not seem to get more involved with infringement. I mean they don't condone companies selling unapproved drugs, yet in a sense, for instance in our case, a drug is being sold that is not approved for the intended purposes many patients are taking it.
Oh well, just my frustration showing. Have a great weekend to you and the board.

Marty Makary to be next head of the FDA. Sounds like he wasn't the biggest fan of GLP-1 drugs. Hope he is aware of V, and is amenable to our new formulation, if it ever comes out.

Nuke, not easy to give an ABC answer. First, one can say that medium intensity statins plus ezetimibe did show benefits over simply high intensity statins. But, this was a meta-analysis, and those are notorious since the authors decide what studies to pick and choose. Now the benefits over HIS by this combo was not as great as what Vascepa showed in R-I, BUT I can't find where there is a description of the statin used in R-I - whether it was Mid intensity or High intensity or low, but we do know that people were generally considered to having their cholesterol under control.

Hate being a PIA, but is seems that understand what North is talking about wrt some sort of settlement (Hikma/PBM/Amarin).   Since I don't quite know about this (North has even alluded to him possibly making this up) and even JRoon was inquiring as to what North was referring to, could you elaborate for us in simple terms we can understand?   TIA

Not massive volume today but 2x average so not bad.  Hopefully this continues.  

You are correct. Basically take all the gains for the year, subtract the losses, and if the losses are more than the gains then you have a capital loss, whereas if you have more gains than losses (totals) then you have a gain. Unfortunately Uncle Sam will only allow you to deduct 3K of losses in any given year on line 7 of form 1040, whereas there is no such limitation on your gains.

So in your example, 10K gains, 23K losses, means that on line 7 you would enter -3,000 and then carryover the remaining 10K loss to the following year.

Forgot to mention that when you match your losses vs your gains for the year, you would also include any carryover losses from the prior year into the calculation.

The one interesting thing is if one has some shares from way back when at a very high cost basis it doesn't take selling very many shares to get overall cap loss to the max of 3K. 

JRoon, is that the amount the mfgr is getting or is that the patient cost?

Kiwi, I am not sure but here is the one thing that might be impacted with an authorized generic. You and others can school me on this but do PBMs or insurance companies only permit one generic version for their coverage/formularies? I swear that I have gotten various manufacturers of GV over the last 2 years all while having the same insurance and PBM. So if they do not single out a particular generic manufacturer, this is what I am thinking.

My insurance a couple of years ago aborted covering V altogether. Now this past July CVS stopped covering it for their commercial plans. Not sure how many other PBMs/ insurers have curtailed covering brand V. But, they all cover GV. So my thought is that an authorized generic V would fall into that generic category wouldn't it and hence be covered. Now, do all the GVs offer their product to the PBMs at the same price, I don't know? How do patients request an authorized generic instead of a non-authorized generic? But otherwise I would have to agree with you PBM go with what makes them the most money.

Anyone have any thoughts on the new revised American College of Rheumatology guidelines for treatment of LN? Aurinia seems to think they are an improvement:

https://www.businesswire.com/news/home/20241118903839/en/Aurinia-Commends-2024-Updated-ACR-Guidelines-for-Screening-Treatment-and-Management-of-Lupus-Nephritis#:~:text=The%20guidelines%20call%20for%20a,acceptable%20maintenance%20dose%20of%20steroids.

Otsuka launching Lupkynis today in Japan:

https://www.otsuka.co.jp/en/company/newsreleases/2024/20241120_1.html

Funny that I see a little perk-up in the stock price (late yesterday and this am pre-market at 53 cents but only 500 shares) as O saw this article yesterday from Zacks. These articles are a dime a dozen and usually meaningless. As a matter of fact I was puzzled by the end of their first sentence: "Wall Street analysts expect the company to report better earnings than they predicted earlier." Is that correct?

Anyway for anyone interested, sorry if already posted:

https://finance.yahoo.com/news/plunging-19-13-4-weeks-143506058.html

Could, I guess I threw out the acquisition idea mostly to highlight that they aren't doing much with that pile of cash. I would be worried about two things with them trying to acquire an accretive asset.  First, I see so many deals where the buyer overpays and gets screwed. Secondly, since they have mismanaged the golden goose they have, no reason to believe they would do any better with another.  

I guess I was thinking of saying that maybe Denner should invest that cash with Sarissa's team or another firm, but thought it was too crass to say, but the point would be to show that the reason we invest in these companies is that they are supposed to do better for us than us simply putting our miney in a money market fund or online savings account.  

Of course we don't know everything and just speculating as to why they haven't started the BB, so there could be some valid reason for their reticence.  We usually find out in the end

Could, it is difficult for me to understand other than they know that their revenue will continue to take hits.

I also wonder if their delaying of the BB has played a role in the depressed stock price. The market thinking the same as you and I that the BB delay/postponement/cancellation, means more bad news for the company ahead and hence the stock gets sold constantly.

It seems to me that they are not using all that cash wisely (again not knowing if there is a financial disaster coming for V in the U.S.) by just sitting on it. If no BB then use it to acquire another asset that is accretive, no?

Just heard that Dr Oz is going to be head of CMS.  Wonder if it means anthing for ARDX or UNCY?

Just out.  Story claiming Dr. Oz being tapped as head of CMS. 

https://www.usatoday.com/story/news/politics/elections/2024/11/19/donald-trump-mehmet-dr-oz-medicare-medicaid/76432777007/

Kiwi. Other than some very small reds in my divvy account, the only red beside ARDX today is CRSP and not much by much.

One thing I find a tiny bit funny is that although the deviations are small, it seems often enough that when ARDX is positive, then UNCY is slightly negative and vice versa. Seems a little odd but it could just be serendipity.

Guess the market didn't think much of the presentation or thinks there is no way Kidney Act passes.  Gonna give Mott a call.  

I assume you are referring to slide 11. I think that, like you say, they are trying to show the potential for Europe. Matter of fact they have a bullet point on the slide:

Kiwi. Listened to the CC this morning. Company seems staunch in their belief that they will be able to continue growth of Xphopah (sp?) albeit whilst taking a bit of hit to revenue. They are in touch with docs and say that the docs are quite aware of the coming situation. https://wsw.com/webcast/jeff315/ardx/1849260

Pretty good writeup about it a month ago.  I know I was drawn to this stock after listening to the CEO sometime this past summer.  Impressed me as quite knowledgeable.  He alluded to them selling the 402 PKI drug so hopefully he is still finding some buyers receptive.  

No question that it has me thinking that if they haven't been willing to at least do a small amount of BB now, that they may know that things are getting darker and not brighter. Are they aware of more insurance coverage drops or the situation in the EU stagnating. Hope I am wrong but it definitely has me wondering.

Kind of a disappointing price action today but at least not a very high volume.  

Yeah, of course a little different in their case. Their delisting not related to be under a buck.

The KRAKEN clinical trial included 233 adults around the world who were identified at high risk of having a cardiovascular event due to very high Lp(a) levels (greater than 175 nmol/L). Researchers evaluated the effects of muvalaplin at different doses—10 mg, 60 mg or 240 mg, taken daily—compared with a daily placebo for 12 weeks. The researchers tested Lp(a) levels using both the traditional Lp(a) blood test and a new test that more specifically measures the levels of intact Lp(a) particles in the blood.

At week 12, the study found:

Compared to placebo, muvalaplin treatment reduced Lp(a) by up to 70% as measured by the traditional blood test, and by up to 85.5% as measured by the new intact Lp(a) particle test. Participants who received either 60 or 240 mg of muvalaplin had similar reductions in Lp(a) levels, both of which were greater than the reductions in Lp(a) levels of participants who received 10 mg of muvalaplin.
Muvalaplin treatment resulted in approximately 97% of participants achieving Lp(a) lower than 125 nmol/L, as measured by the intact Lp(a) particle test, or approximately 82% of participants as measured with the traditional blood test.
Compared to placebo, muvalaplin lowered apoB, one of two major proteins that make up Lp(a), by as much as 16%, with no notable change in levels of high-sensitivity C-reactive Protein (hsCRP), which is a way to measure heart attack and stroke risk.
“We were encouraged by the degree of Lp(a)-lowering in these patients who are most likely to benefit from its use and by the safety and tolerability,” Nicholls said. “While muvalaplin appears to be an effective approach to lowering Lp(a) levels, we still need to study whether Lp(a) lowering will result in fewer heart attacks and strokes.”

The study had limitations, including that it was relatively small and trial participants were treated for only 12 weeks. “Larger, more diverse and longer-term studies are needed,” Nicholls noted.

Capt., thanks for all this work you put in getting this data to us. Appreciate it. Question pls. Slide 1 shows Sept V caps/pills down by about 8,000 compared to Aug.

Yet, slide 4 from the bars seems to show more revenue in Sept than August. Any explanation for that? TIA

Ha. Not me. Would be nice to know Mott's net worth to know how important his investment here is

I did the same Kiwi this am

I just reposted the link that JRoon posted in a reply to you.  The title is the same one that you originally posted talking about additional supplier. I think the link you have where it says somethjng to the effect that it is not ready and news is pending is broken or a glitch.  My guess is we will wait forever for that link to bring any news.  But I could always be wrong.  But look at the first link you posted this morning and title is about an additional supplier. 

https://amarincorp.gcs-web.com/static-files/cbd9a29d-3149-4842-a9d2-ebcf48e21169

Very top left hand corner