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I doubt that the small number of patients recruited for the Brave study will yield a statistically significant positive result...but even a reasonable trend towards a positive result should cause the FDA to approve Vascepa to treat Alzheimers, while a BP initiates a larger study.
The Brave study last update was October 6, 2022 ....If an extension to the planned completion date for the study had been decided on, IMO it would have been announced by now.
I assume the results of the study will soon be announced...or, failing that, we will hear of another extension of the completion date.
The Brave study was started in 2016 with 150 participants...The study status has since been reviewed on a yearly basis and it has not been decided to stop it.
The R-IT study had 8000 participants and after it was stopped, it took 6 months for the results to be released..With just 150 participants in the Brave study, it seems as though it should take less time than 6 months for the results to be compiled and confirmed and released after completion of the study.
A fixed dose combo with a statin plus Vascepa may present difficulties to develop if it depends on a technique, in which a statin is sprayed onto a Vascepa capsule...However a blister pack containing either a 20 mgm lipitor tab or a 40 mgm lipitor tab or an 80 mgm tab, plus four 1 gm Vascepa capsules, presents little difficulty...It would need manufacturing and marketing, which could be better done by a BP than by Amarin...I would be a customer for this product and I assume many other patients with a history of CVD would also find this convenient.
Since the statin and Vascepa are already FDA approved, the FDA would probably approve this new product quickly.
This is a simple solution while the spray-on technique continues to be developed.
Capt...This is compelling evidence that a FDC with a statin and Vascepa is necessary to impress patients that BOTH meds should be taken together for best results.
The many patients, who are already on a statin med should be given an Rx for a FDC.
Inflammation in an organ system can produce other changes in that organ which can, in turn, produce a cascade of serious consequential changes...That is what Vascepa is inhibiting in CVD and in AZ.
e.g. Inflammation in arteries leads to atherosclerosis-leads to obstruction of arteries-leads to heart attacks- leads to death.
Don't underestimate the importance of the suppression of inflammation by Vascepa all over the body and in multiple diseases.
Steroids also suppress inflammation, but they cause serious side effects...Vascepa is a safe drug.
The anti-inflammatory effect of Vascepa will slow down the production of amyloid, but is less likely to remove the amyloid already produced in the brain by injured and tangled nerve cells.
golf...My expectations are for a share price of $9...or higher if the Brave study for Alzheimers trends positive...even higher if this small study reaches statistical significance ....I expect positive results, but I also expect it might take a larger study than Brave to achieve s.s. and spur the FDA to approve Vascepa for AZ.
Even so ,I think AZ is so common and so devastating... and Vascepa so safe and relatively inexpensive that the FDA could approve it on an interim basis, pending completion of further studies....It would definitely make for make for an interesting Adcom!
There will be a bidding war...but probably not for $20+
The great advantage that penicillin had..was that it could treat acute illnesses and the results could be seen,in many cases, within hours....Statins treated less acute illnesses and they took longer to be accepted globally.
Its like the environment...In the end it needs to be controlled, but who wants to pay to control it now.
KIWI...The MO scam has now been completely debunked for everyone, except for those, who will never change their minds, no matter what the evidence is...The problem is not now science... but not low enough price and not big enough marketing...Vascepa will become globally accepted as a treatment for several conditions when these problems are solved by a BP.
Alzheimers is often a slowly progressive disease...A family member with AD was recently started on Vascepa at my urging He was on it when I recently asked how he was doing...The answer was that he was was discontinuing Vascepa after a month because no difference in his condition had been noticed...I explained that the Brave study had been going on for 5 years and should provide him with some encouragement and a reason to continue Vascepa.
If Vascepa gets approval for AD. it will need a lot of marketing.
Duke...As been noted by other posters, the Brave study is a highly invasive study, with serial spinal fluid taps...and I doubt that Brave would be carried to conclusion unless there were some signs of a positive trend in results....It's a small study and it would be great if Brave could reach statistical significance...but, even without S.S., a trend in the right direction might garner FDA approval for the treatment of Alzheimers disease while other larger studies are being performed.
Slevin...Thanks for posting...QUOTE..."Heightened extravasation of the lipoprotein-Aß in T2DM amplifies NEUROVASCULAR INFLAMMATION and neurodegeneration, resulting in accelerated neuronal cell death and premature cognitive decline."
This is another clue as to why the anti-inflammatory effect(as well the lipid lowering effect, of Vascepa) may play a role in palliating Alzheimers(especially when used with statins)...We await the results of the Brave study to soon shed more light on this all too common disease.
This is yet another reason, in addition to reduction of CVD, for type 2 diabetics to be on statins and Vascepa.
marjac...QUOTE..."The ship has completely sailed on any "mistake" argument. The only narrow pathway even theoretically available is a fraud on the court action"
A fraud would be almost impossible to prove without a confession of the guilty party...and that is very unlikely...I'm afraid you're correct ...The time for Amarin to provide standing for the "mistake" (or more likely the fraud) was at the time of the EPADI (Marjac) appeal and, sadly the injustice can no longer be righted at this late date, due to the ostrich policy of the BOD at that time.
Marjac...QUOTE..." EPADI II's Rule 60 Motion was ultimately denied on grounds of standing, but the merits were never adjudicated...Either the cropping of the Mori study results was a crucial "mistake"...or, more likely, it was intentional fraud on the court....This episode sticks in my craw and I am aching to see the matter resolved.
Even if it a was mistake,it changed the judge's decision in the trial, and It is imperative for the future to see the matter resolved...not only for Amarin, but for the court system and justice.
A new trial should take place with actual facts and not the cropping distortion.
Kiwi...Marjac has done a lot for Amarin,..already having submitted an extensive brief on the fraud case...He now deserves a chance to resubmit it it with the backing(standing) of Amarin.
I am not advocating that the verdict be overturned be in favor of Amarin but that there be a new trial, in which the authentic evidence is considered.
Bird...QUOTE..."Amarin's lawyers failed"....Yes, they did, but so did the judge and her clerk fail to pick up the clever fraud on the ninth circuit...If this fraud on the court is allowed to succeed unchallenged, it will set the dangerous precedent that... if a party to a suite is clever enough to crop the end a chart or even the middle of a chart, that dishonest party can distort the the facts and get the verdict it desires.
It is incumbent upon Amarin to press its fraud suit in the ninth circuit, whether they win or lose....The suite will spell out how Amarin came to lose its high trig patent by chicanery in the trial...i.e. by introduction of a cropped chart, which determined the outcome...as mentioned by the judge in her decision.
Then, to make matters worse, infringement of Amarin's R-IT patent was allowed by the HW law to proceed thereafter.
Denner needs to appoint a new COB to sell Amarin....KM can do his best to strengthen the company...but you can't expect him to sell himself out of his job.
Amarin needs a leader for Europe and another leader for the U.S....A BP could provide those.
Questions I have about when or if Amarin is going to pursue the following...
1.The fraud on the ninth circuit, which had its intended effect of decimating Vascepa
2. Getting FDA approval of a FDC drug with a statin plus Vascepa
3. Getting FDA approval of MND-2119
4. Getting FDA approval of a FDC with a statin plus MND-2119
PWO treated the U.S. market as a dead issue...I hope Denner does not treat it the same way.
IMO the most interesting part of the PR was that KM's photo was still at the top of the PR,...The purpose of the PR was to give reassurance to shareholders that Amarin had them in mind, but no real news was yet available.
Of course the generics would attempt to infringe....but a FDC with a name like "Vastatin-CVD", written by the Doc on the prescription, insurers and pharmacies would be hard pressed to say that the drug was NOT being used for CVD but, just being used for high trigs.
AJ...QUOTE..."Indeed, why has it taken so long to develop since 2013?"...
In 2013, the FDA had rejected the CVD indication for Vascepa and Amarin was facing a long and an expensive R-IT study...They had to mortgage their patents to borrow enough money for the study...They were not in the position they are now in.... with FDA approval of Vascepa for CVD and 300 million in cash plus no debt.
I agree that, in retrospect, after the judge Du decision, Amarin should have immediately initiated work on a FDC.
Rose...I agree that a FDC with a statin and Vascepa for the treatment of CVD makes Vascepa better known to Docs, who are already prescribing statins for their CVD patients...So many Docs now are prescribing statins and so few even know about Vascepa.
Statins are so cheap that a FDC may add little or nothing to the price of Vascepa...A FDC is a marriage, as they say, made in heaven.
Rose...Ekman and J.T. could have initiated testing by Granowitz immediately after the Hickma gV became available...The necessary studies could still be done this late date...The studies might turn out not to be as expensive as the Amarin cash spent by PWO in the proxy fight of the last few months.
What makes this a NEW situation is that the generics are not using the patented capsule for their gV that Amarin uses for Vascepa...In a failing attempt to obviate the oxidation, which limits the effectiveness of the EPA(THE ACTIVE INGREDIENT WITHIN THE CAPSULE), the generics are using fillers ,which not only make the color, taste, and smell of their gV product, different from that of Vascepa, but these fillers are potentially harmful.
It is time to bring this festering situation to the attention of the FDA!
PWO had little interest in selling Amarin to PFE or to anyone else IMO...He was continuing a GIA strategy and the interests of the shareholders were far from his mind.
The low rates on the SVB investments would indicate that the SVB investments were not ones with very high risk..so I am expecting that investors will take no more than a 40% haircut.
jas...The FDA is not immune to political considerations...The current political winds are currently more in favor of cheaper generic drugs as opposed to healthier branded drugs.
jas..."100% upside - a win would Clear the Sky in just one blow."...A win with the FDA would do just that...A win with the Court system would lead to appeals by the generics.
In the Vascepa capsule, the preservatives are 3% (in the capsule shell-glycerol, sorbitol)
In the gV capsule, the preservatives are 35%(glucitrol, sorbitol...
gV Can't be as good for you as the pure EPA in Vascepa
Docs and patients are unaware of this.
This situation is begging for a further discussion with the FDA!
The EPA is the active ingredient in Vascepa...The effect of the EPA within the gV capsule is weakened by excess oxidation due to its inferior capsule...but it's effect is, in addition, weakened by the fact that than it has ONE THIRD LESS EPA than the Vascepa 1000 mgm capsule (i.e.due to the need for the generic companies to allow room for the XS fillers in their inferior gV capsule...in a faiIing attempt to curb EPA oxidization in their product)...Is gV then really bioequivalent to Vascepa?...I don't think so.
Patients ignorant of the superiority of Vascepa are buying either gV, which is slightly cheaper than Vascepa....or Lovaza, which is much cheaper than both V or gV...so gV competition is more with Lovaza than with Vascepa.
If your main focus is the price, rather than your health, then you buy Lovaza...Europe deserves credit for taking Lovaza off the market, while Lovaza is still unaccountably outselling Vascepa in the U.S.
Amarin has never, to date, adequately explained to the public why they are wasting their money on Lovaza.
The generics may or may not be identical to each other...But they are NOT identical to Vascepa, which has a patented gelatin capsule preventing the oxidization of the vital pure EPA .
The more generics competing with Vascepa, the better...This will minimize their ill-gotten gains and make more of them susceptible to become defendants in infringement lawsuits.
Let's assume that Denner calls PFE and says let's talk...and PFE replies,fine...you send some of your people and we'll send some of ours and let's have lunch tomorrow.
Do you really expect Denner to make that interchange public?
duke...This is a VERY unusual case....This case deals with a fraud on the court...in which a document, submitted to the court, was CROPPED...in order to present exactly the WRONG factual conclusion to the court...a conclusion, which instrumental in the court's final decision.
cbd...BP continues to waste billions of dollars on the false premise that Alzheimers is due to amyloid deposits...Alzheimers is due to inflammation of the brain....Deposits of amyloid are the RESULT of inflammation of the brain...NOT THE CAUSE!.
By the time amyloid develops. it is already late in the game.This isn't to say that Vascepa, which has been proven safe and effective for CVD, can't also be of help in slowing the progress of this terrible disease!
The study (by Lilly) examined solanezumab in patients with amyloid plaque but no clinical Alzheimer's symptoms.
QUOTE from Lilly.."The A4 Study concludes our clinical development of solanezumab and indicates that targeting soluble amyloid beta through this mechanism is not effective in this population," said John Sims, Eli Lilly (NYSE:LLY) head of medical, global brand development "
This is where Vascepa,with its proven anti-inflammatory properties, can play a role!