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Think you are right about Kaiser. Also is UNCY waking up?
As Orbapu states, from the link I posted, the sponsor on Dec. 7, gives no indication of any results being released.
I am not one who thinks the results will be a big deal either way, but nonetheless, everything indicates that no results have been released, but I could be wrong.
It would surprise me though because even negative results would have touted by naysayers. We have not heard a peep.
Here is another one AZN buys out Gracell.
So look at this link. Information dated Dec 2023 - well past the date of conference and no inkling of any results for the study:
https://ichgcp.net/clinical-trials-registry/NCT02719327
I think you and BBI posit a scenario that is very plausible.
One would think that if results had already been presented, that positive or negative, we would have heard. It is not like some instances where drug companies have hidden negative results, this study was not conducted or controlled by a drug company.
Can’t speak for Sleven we should wait for his response but my guess would be that he is going on two things:
1). Results were presented at the conference as claimed
2). If results were positive, we (and the medical community at least) would have heard immediately thereafter.
What is puzzling is that the poster information clearly states that they were to divulge IPE’s effect found in the study at the conference. And yet, it seems that virtually 2 months later not one iota of reporting of what the results were that were supposedly to be released at the conference.
For anyone wanting to read the full description:
"LP019- THE BRAIN AMYLOID AND VASCULAR EFFECTS OF EICOSAPENTAENOIC ACID (BRAVE) STUDY. C. Van Hulle1, H. Zylstra1, K. Cronin1, A. Cole1, E. Beckman1, A. Eierman2, M. Blazel3, K. Lazar1, K. Johnson1, L. Rivera1, C. Gleason1, H. Zetterberg4, S. Johnson1, C. Carlsson1 (1. University of Wisconsin-Madison - Madison (United States), 2. Medical College of Wisconsin-Green Bay - Green By (United States), 3. Case Western Reserve University School of Medicine - Cleveland Ohio (United States), 4. Sahlgrenska Academy - Moldal (Sweden))
Background: Alzheimer’s disease (AD) pathology is characterized by amyloid plaques, neurofibrillary tangles, and reduced regional cerebral blood flow (rCBF) in brain regions related to memory and learning. The omega-3 fatty acid eicosapentaenoic acid (EP A) has beneficial cardioprotective properties, reducing inflammation and enhancing endothelial function. Icosapent ethyl (IPE), a purified form of EPA, improves cardiovascular outcomes and strokes in at-risk patients (NCT01492361). EP A lowers triglycerides without raising LDL, unlike docosahexaenoic acid (DHA)- based omega-3 formulations. Veterans report higher rates of some cardiovascular diseases (CVD) than non-veterans. Given Veterans higher risk for vascular dysfunction, and the high co-occurrence of cerebrovascular dysfunction with AD pathology, improved vascular health may be a key modifiable risk factor for delaying the onset of AD among Veterans. Yet, Veterans remain an understudied population in AD related clinical research. We conducted a proof-of-concept investigation into the efficacy of an FDA approved high dose EPA in improving cerebrovascular function in healthy, cognitively unimpaired Veterans. Methods: Veterans Affairs (VA) eligible Veterans were invited to enroll into an 18-month randomized, placebo-controlled, double-blind, parallel-group clinical trial assessing the efficacy of Vascepa® IPE. The primary outcome is change over baseline in 18-month rCBF on treatment compared to placebo. Secondary outcomes are change over baseline in 18-month CSF biomarkers for AD pathology (Aß42, pTau181, total tau). An exploratory aim is to investigate change in global cognition. At baseline, 9 and 18 months, participants had an MRI scan, LP procedure, and completed the Alzheimer’s Disease Cooperative Study Preclinical Alzheimer’s Cognitive Composite (ADCS-PACC) battery to measure global cognition. To characterize the vascular health of study enrollees, we measured baseline cardiovascular risk factors (atherosclerotic cardiovascular disease [ASCVD] risk score, body mass index, waist-hip ratio, blood pressure, and heart rate). Participants reported on their medication use, health conditions, dietary intake of fish oil, physical and mental activities. We also captured experiences unique to Veterans including military experience, TBI exposure, and PTSD symptoms. Results: We screened 206 individuals for exclusion criteria (memory disorder, inability to complete study protocols); 179 were consented and 131 were randomly assigned in a 1:1 ratio to either placebo or 4mg/day IPE. We have previously presented baseline demographics including military experience, self- reported health, and the baseline associations between cognitive performance and hippocampal volume, cardiovascular risk, and neighborhood disadvantage. Trial outcomes will be completed in Sept 2023. Here we report on mean baseline values for the pre-specified outcomes. At baseline, N=127, 119, and 129 participants had an MRI scan, LP procedure, and complete cognitive battery, respectively (N=111 participants had both successful baseline MRI and LP); to date, 110 participants completed all study visits. Mean global rCBF = 50.2 mL/100g
S93
All abstracts are embargoed until the day and time of presentation at the CTAD Conference
tissue/min (SD=16.2); mean CSF values for Ab42 = 1296 pg/ mL (SD=581), phospho-tau181 = 19.7 pg/mL (SD=6.67), total tau=223 pg/mL (SD=71.8); mean global cognition as measured by the ADCS-PACC = -0.0001 (SD=0.64), suggesting normal amyloid and tau levels and cognitive performance at study entry. Conclusion: The impact of IPE on cerebrovascular health in cognitively unimpaired Veterans will be presented at the conference. Key words: Veterans, omega-3-fatty acid, cerebral blood flow, cerebrospinal fluid. Clinical Trial Registry: NCT02719327; https://clinicaltrials.gov . Disclosures: The authors have nothing to disclose."
Sure, but at this link:
https://www.ctad-alzheimer.com/files/files/ProgramPrel_CTAD2023_16oct%20FINAL.pdf
If you scroll down to "Listing of CTAD23 POSTERS",
Lp019 is listed as "THEME: Clinical Trials: Results".
Thanks for posting. IPE most effective and cheapest (other than generic statins).
Could, Kiwi (I believe) once posted data showing that the majority (by far) of BP buyouts occur around the time of phase III study results (both just before and just after). I suppose they (BP) feel they don't want to wait until the small bio mucks up the launch of any drug. That is why Amarin missed a big opportunity around R-I to entice some BP to gobble it up. Of course after the DuDisaster forget about any interest.
Bristol buying KRTX for 14 billion
Possibly, but that works better when you have sales reps bringing that stuff during a visit. Amarin cut those people a while back.
We should see the $12 area shortly.
Yes, agreed. I was responding to a post which had a link to a story that had grossly incorrect numbers for Sarissa’s Amarin holdings.
Not sure where they are getting this information:
"Sarissa Capital Management holds 10,442K shares representing 2.56% ownership of the company. In its prior filing, the firm reported owning 4,910K shares, representing an increase of 52.98%. The firm increased its portfolio allocation in AMRN by 122.48% over the last quarter."
From what I have seen, Sarissa, as of Dec. 1, 2023 holds over 13 million shares.
https://hedgefollow.com/funds/Sarissa+Capital+Management
Thanks Capt. Hopefully some Eurocentric BP can see the growing scripts and extrapolate that to the future and rest of the EU (when it comes completely online) and realizes what they could do with Vazkepa and sets its sights on Amarin.
Hopefully this is the beginning of a nice move up in price and there is something positive behind it. Awfully quiet about this strategic review.
Jasbg, you are correct that GV is included in the statement that GV is not approved by the FDA for CV risk reduction. But the first statement:
That "Lovaza and its generics are not AB rated to prescription Vascepa" and the statement "In studies Lovaza and its generics failed to show CV benefit"
are referring to generics of Lovaza
Jasbg, I believe the Generics referenced in this document are the generic versions of Lovaza and not GV.
Yep, DAR, we are all in the same boat here (well maybe all except for a few who just come here to bash). It has been frustrating.
Even if we forget about the disastrous DuDisaster, one would still think V should have a bright future, but all the facets or aspects our society seem to be working against it. Docs not really aware or appreciating V, insurance companies not thinking long term and only of current profits, legal system turning a blind eye to infringement, etc. on and on. So that is why I say frustrating. And, anything positive, (like EU reimbursements and rollout) seems to move at glacial speed.
Nuke, DAR, I was being slightly flippant with my remark to Nuke about how Humana must be paying him since it seemed as though his total premium was at or less than the typical part B premium. I am familiar that there are a number of Medicare Advantage plans who basically have a $0 plan premium. They just take your part B premium.
Apparently, back when the idea of Medicare was first thought of and proposed, some proponents wanted it to cover the entire population, but vested interests like the insurance industry was able to scale that back to where it only covered people over 65. Of course that is the segment of the population that racks up the most medical costs and they were happy to off load them to the govt. Now, decades later, they have figured out a way to squeeze back into that segment with MA plans.
Maybe that is why Denner is being shunned since he screwed NVS. They dramatically overpaid.
Isn't Medicare Part B more than $165 mo by itself? That means Humana is paying you money to take their Advantage plan.
So there has been some thought that improvement - or rather steadiness in V scripts is partly due to the HN settlement.
From what you indicate, it obviously had no effect on Cigna’s decision. It is possible it is not affecting anything and that V’s scripts are due to negotiations and heavy price cutting.
Yep, the dropping messes up your progression series. Two steps forward one step back.. Mostly it has been the other way around.
Need something to turn this around permanently. Moved out west two months ago and it is costing me a fortune for almost everything.
Wish we had some kind of admonition like that here Stateside. The EU does not reimburse for omega-3 FA mixtures either.
Agreed Capt.
Omega-3 FA mixtures should only possibly be prescribed for a very short term to treat extremely high trigs wet pancreatitis
CRSP getting whacked again this morning. No idea where it heads later.
Not a question about reading anyone’s mind, just look at the data concerning buyouts. Jess was surprised at that buyout in a company before drug approval but he shouldn’t be. The evidence is there for anyone to see and willing to admit.
Either I never knew or I forgot but it appears that we are also dealing with mineral oil as a placebo in BRAVE. The Clinical Trials site does not mention mineral oil (unless my Find function does not work) but Dr. Carlsson mentions it in this video (4:40 mark). Another thing I don't like much is how many times she uses the word fish oil:
https://classic.clinicaltrials.gov/ct2/show/NCT02719327?term=icosapent+ethyl&cond=Alzheimers&draw=2&rank=1
Not in the first place back then. But as malaria can now be treated and usually cured that gene mutation is not of anywhere near the same value and is detrimental in terms of causing pain, possible stroke, and lung issues.
I gather you don’t suffer with sickle cell disease.
I believe it has been pointed out before that the vast majority of buyouts (in the biotech space) occur around (both before and just after phase III readouts). That way the BP can do the rollout as they wish - properly. That is why there was so much speculation with Aurinia back then. The longer the time passes and the more any rollout trips over itself, the less any BP stays interested.
Thought the headline was news enough and hoping someone who had access could gives the details. Main point was that M&A activity could be heating up (something we all here are looking to) but I think we need some catalyst to put Amarin back on BP’s radar screen.
Unfortunately for us (unless something like BRAVE changes things), there isn’t that much interest in Amarin at this time:
https://www.barrons.com/articles/biotech-abbvie-roche-stock-acquisitions-aa44cb59?mod=RSSMSNBarrons
I hold that stock and was looking at it this morning at $75 and thought since approval was expected I should dump and just then doorbell rings and window shutter installer here to do work. By the next chance I had it was below 70. Well at least there are no Generics that are in court with them so maybe in a few weeks it will continue upward.
Actually North the shares jumped up 6 bucks before FDA announcement but are now DOWN $7 after approval.