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I would love to be wrong (never mind love, I need to be wrong) but I believe that although there will be some positive news from BRAVE, I also don’t believe we will have the type of news that would pop the stock 5 bucks.
If they continue GIA PG will be out in June.
The only danger in that, possibly, is if V positively affects those markers but does nothing for the disease, then the markers might be deemed useless.
So I see numbers that range from 15% to 25% of people have the apoe4 allele with apparently 2-5% having 2 copies. Although most seem to quote 15%.
So hopefully, of the 75 in the study, if we are a bit lucky we get less than 10 with the gene variant. But of course this is Amarin and we know what kind of luck we have.
Thanks. From your link:
“The disordering effects of DHA may counter EPA stabilizing effects and explain discordant clinical outcomes with different n3-FA formulations.”
Can we grab Nissen, AF, et al, by the scruff of the neck and force them to read this. Then we should educate all those doctors who tell their patients to just take fish oil. Then we should repeat with those docs that put CVD patients on Lovaza.
What you highlight should make us all be ready for possible failure in BRAVE. Hope not but the road of clinical studies on AD is littered with failures. It is a bitch of a disease.
The DuDisaster screwed everyone because the CVD benefit that V has should have been enough to reward all of us handsomely.
Monoclonal antibodies.
Do you know the average time of strategic reviews? I assume the length of time is sometimes an indication of either non-interest or some complicated negotiations.
Just have to wait and see.
I also find it hard to believe that after positive Brave results, docs would write scripts for V off label, when there are already FDA approved drugs. Of course maybe the fact that V is many many times less expensive than those could play a role. Of course docs could also just continue their stupid mantra and tell patients to buy fish oil.
Jroon, my post outlined my fears and the negatives as I see them, however, on the flip side you are correct that a big positive is that it is a biomarker study which definitely is something that could be differentiated between the groups in such a short time frame.
Marzan, my fear with BRAVE is that it is a very small study ( so even if results were great, the naysayers would have that to whine about), and maybe more concerning is that the small group in this study all have had no clinical diagnosis of any memory issues coming into the study. Then it is also a relatively short study so will there be enough time to show V’s effects?
"We are very pleased with our overall results for the first nine months of the year. Reporting another strong quarter of results reinforces our ability to execute and deliver against key metrics. Our team continues to focus on business fundamentals and steady performance," said Peter Greenleaf, President, and Chief Executive Officer of Aurinia. "We continue to deliver new data on LUPKYNIS and grow the overall LN market. In addition, we received a $10.0 million milestone from our collaboration partner outside the U.S. as a result of securing pricing and reimbursement approvals in three of the five major European markets."
Don’t we all know a substance that helps with this?
https://fortune.com/well/2023/10/28/deepak-chopra-inflammation-number-one-pandemic-solutions/
Not particularly a fan of Chopra but good to get out the word on inflammation.
Not to mention that besides all the things Canes and you say, it should never have gotten to any trial. Either a settlement or company should have been sold to BP at time of top line results and let the BP deal with it.
Thanks JRoon. Curious but assuming the preliminary update may not touch upon any data or results (as usually first data coming out of trial is the top line results).
Guessing it will be other facets describing the trial in a little more detail. Appreciate the heads up. I think you, I, and others were postulating data in the 1st qtr 2024 so this meshes.
Yep still here Kiwi. Have been totally distracted with this move to Pac NW.
Wonder if you are referring to Bionano BNGO. That was another that JL touted.
Thanks for posting North. Although I am more sanguine about how these drugs could impact V's prospects. So, it appears that lean body mass gets lost to a degree under those drugs you mentioned, but it is also true that lean body mass is lost whenever a person loses weight, to some degree. So, I would think that most docs will not dig deep and just rationalize the muscle loss with those drugs by saying that that is a normal occurrence whenever a person loses a bunch of weight.
https://www.healthline.com/health-news/ozempic-muscle-mass-loss
Yep. For me, it is to see and hope that the increase in revenue from the EU overrides the deterioration in revenue here in the U.S.
What you say makes common sense but unfortunately we have seen the market value companies on future promise and not specifically current financials. For many years here on this board many of us could not understand why analysts were not giving more value to the future of V in the EU. Well, now we know that they were correct in terms of it being a very, very, slow and arduous process there. Hopefully, there is something soon that changes the perception of Amarin's business going forward, otherwise the market seems to care less about the current financial position.
Absolutely. If one goes down memory lane and reads the link posted by John Hancoque concerning possible BO interest in a high flying Amarin just before label expansion and look at the disaster it has become, it is impossible not to recognize what a disaster the DuDisaster was.
This was management’s business and they should have known that a loss in that trial would descimate the business. Without the DuDisaster a capital raise could have been done at any time, not to mention that instead of the capital raise Thero should have been laser focused on selling the company.
Thanks scxj and JRoon. Good news. I wonder what the cost of the drug is in mainland China? Is it covered under some sort of government system?
He definitely didn’t do his fiduciary duty in protecting the company.
So I take a baby aspirin with mine. Do you find that you don’t bruise/bleed very easily? Lately I have found myself bruising more easily when I am doing more physical things.
Thanks Capt. I was thinking more along the lines of an escalating dose study where they might identify the most effective for the least side effects and to see at what dose the negative effects become too great.
Did Amarin ever do any dose escalation studies?
I used to sell Carlson EPA gems and before getting on V I used those as well. A good product.
I find that moving my HDL is not something that is easily accomplished. From what I have seen, genetics seems to play a major role in controlling HDL. Yes, certain dietary habits and exercise can affect HDL, but in people like me, very little.
Haven’t notice a big change in BP (also on V for 5 years) and I take 2 meds for it.
I think if it wasn’t for Iljin that would have happened at this last AGM.
Sure, why does everyone think those Generics have been falling over each other to sell V.
I personally think they were a little stupid not waiting for Amarin to develop the market though.
Not Amarin specific (although our situation is not great). BioTech researcher posted this tidbit elsewhere indicating worst biotech market:
https://twitter.com/buysidebio/status/1709195750666613124
And omega-3 FAs are not being reimbursed for or covered by gov't insurance.
And someone may ask why does the FDA permit the sale of those here in the States. Well, the answer is that the FDA only approves Lovaza for super high trigs. Where I would like to blame the FDA and FTC is that they are not going after the doctors and insurance companies that are dishing out Lovaza to people for CVD.
Virtually all bios and more are getting hammered today - and have been for a while. Anyone who thinks this is just Amarin related are either smoking the wacky tabachy or they should be
Thanks Sleven. Good write-up on Vazkepa.
No question the baby is getting thrown out with the bathwater in the case of Auphie, since they are in a good cash position and are actually earning a lot more interest than they are paying, by far. But Universe forbid that this strategic reviews comes up empty for a buyer.
Especially if we were trading at $15 on high expectations.
Part of the problem is the ignorance and stupidity of doctors (what do you call a med student who graduates at the bottom of his class? - Doctor) and the other is that Amarin lost the patent battle in the DuDisaster so shortly after R-I label expansion that they curtailed their advertising shortly thereafter.
If Brave is successful, the company could try to leverage that in the EU, but you are correct that in the U.S., generics would grab a bulk of scripts.
As far as Ozempic, another example of moronic doctors. The lawsuits are coming out of the woodwork now about those serious side effects. Of course doctors get played by the advertising as much as by their patients.
Yes, Kiwi, it is rather interesting (and perplexing at the same time) that one area - Midlands - is doing so well compared to all the rest. No real explanation why that is, but two thoughts about that. First Holt indicates that they see this discrepancy and will proceed to correct it. Secondly, by the good response in Midlands, it shows that Vazkepa should eventually be successful in the UK.
Congrats on the SLNO.
Maybe your best post here.
Kiwi, you make a good point that I forgot to factor in. Of course the big investors may have a better grasp as to the lower margins that Amarin is now garnering.
3 1/2 years since the DuDisaster and still dealing with inventory mismanagement from long ago.