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TalShu...Thank you for this instructive post...It has been almost a year since Steve Ketchum said in August 2022...“THE FIXED DOSE COMBINATION OR FDC PRODUCT IS IN THE EARLY STAGES OF DEVELOPMENT....IF SUCCESSFUL, THE COMBINATION THERAPY WOULD BE A GAME-CHANGER for patients since it will carry the most significant cardiovascular risk outcome benefit label AND WOULD HOPEFULLY PROVIDE ADDITIONAL MARKET EXCLUSIVITY”
Ketchum's field is research, not marketing...Berg's field, however, is marketing...Perhaps Berg, in consort with Amarin's legal department, could provide some guidance about the 'ADDITIONAL MARKET EXCLUSIVITY' remark of Ketchum...Does Amarin have a patent on a FDC?....Would the exclusivity depend on a FDC being a new product?...even without exclusivity, a FDC would still carry the 'significant cardiovascular risk outcome benefit' label....as opposed to the generics, which do not have approval for CVD reduction.
KIWI...In order to begin taking Vascepa. the triple by pass patient would have to first have an Rx from his DOC, could access the whole situation....
I have been on blood thinners and Vascepa for 8 years with no bleeding episodes.
jas...I agree with there is a new inconvenience caused by the recent disappearance of the ability to only clic on "newer...but, not "older"... for those posters, who want to retrieve older posts...I came to this board back when J.L. switched us posters from a previous board... after the other board had decreed that there be only very short posts...I hope that IHUB does not implement that as a next decree....I also notice that the adds are getting inconveniently larger, now taking up about a third of the screen...
KIWI...most recent metabolic studies of March 2023...
"CHOLESTEROL 152 mg/dL
TRIGLYCERIDES 60 mg/dL
LDL 71 mg/dL"
I eat no meat, chicken, or fish.
I spoke to an acquaintance yesterday, who's brother is scheduled this coming week to have a triple by-pass...The brother had never been prescribed Vascepa...and my acquaintance had never heard of it...I advocated for him to ask his brother to consider Vascepa if possible, before the triple by-pass, or even after it.
ORB...I agree...Patients, who are intolerant to statins,can take a pcsk9 inhibitor to get their LDL down... but then, in addition, they should also take Vascepa....For those, who can tolerate them, statins are much cheaper and easier to take than pcsk9s...and statins come in a variety of strengths, which does make packaging a FDC something of a challenge.
Orb...I have taken 80 mgms. of Lipitor since 2010 when I hard my first heart attack...At that time, I had one stent placed...My LDL, which was well over 200 mgms./dcl prior to the MI, has been normal since being on statins......My second heart attack came eight years ago, with two stents being placed...That was when I started Vascepa and I have been OK since....IMO, patients, who have had an MI and are not taking statins PLUS EPA, are playing Russian Roulette....That is why I am "obsessed" with a FDC...
Let patients know that statins PLUS EPA can reduce incidents of CVD.
capt....This announcement is very important...not only because Vaskepa will now be available to patients in Spain...but also because it heralds the era of further acceptance of Vaskepa as a vital drug for reducing CVD, one of the scourges of humanity.
For most patients taking 'Statin-Vascepa-CVD' FDC, a package with 2 to 4 tabs of 40 mgms. of Lipitor attached to the bottle of Vascepa would be appropriate...For those on 10 or 20 mgs. of Lipitor... they could still buy the Vascepa and Lipitor independently.
An excellent way to alert Docs as to the value of EPA in reducing CVD...is to let them know that, while they already recognize that statins are effective in reducing CVD...statins, taken together with EPA, are EVEN MORE effective...Statins are very cheap and could provided FREE to patients with the EPA...A small package of statins could be attached to a bottle of EPA and marketed as a FDC product with the same price as Vascepa...with the brand name...'Statin-Vascepa CVD'.The increase in prescriptions would more than cover the increased costs to Amarin.
Tats...The statin-Vascepa FDC could be named Vascepa CVD or statin CVD to discourage generics from infringing...It would also be especially helpful if Amarin had a patent on a FDC, which has actually been suggested by previous IHub posters.
A blister pack could contain 20 Vascepa capsules and 10 smaller statin pills in each card with at least 5 cards or more to a box....
I have seen such packages in an OTC blisterpack med...The manufacturing should not be that difficult or expensive.
My daughter has been unable to get her Doc to prescribe Vascepa and uses Pharma EPA Restore instead, which comes in such packages with blisterpacks
The most efficient path to a FDC with a statin plus Vascepa is....from perspectives of research, government approval and marketing, is apparently a blister pack product, which could be accomplished on fast track at relatively small expense...
Why not apply now for approval from the FDA and from the ROW for such a product...A FDC in a single tablet form could be put on the back burner while the blister pack product paves the way to acceptance and profit.
JR...Lilly tiptoed into SGTX, observed its potential...and then decided to go in whole hog.
cbd...CSPC seems huge...The potential market for Vascepa in China is also huge...Perhaps CSPC could make a deal with Eddingpharm to market Vascepa in China.
rose...SGTX recently did a reverse split just to stay on the Nasdaq list...
QUOTE...Sigilon Therapeutics, Inc. (SGTX) will effect a one-for-thirteen (1-13) reverse split of its Common Stock. The reverse stock split will become effective on Tuesday, May 23, 2023"...
Then Lilly bought it recently at a 700% increase in price....WOW!
QUOTE" Pfizer in pact with CSPC to sell oral COVID therapy in China
07:45 AM | Pfizer Inc. (PFE) | By: Dulan Lokuwithana, SA News Editor
CSPC Pharmaceutical Group Limited (OTCPK:CSPCY) (OTCPK:CHJTF) announced a strategic partnership with Pfizer (NYSE:PFE) on Thursday to launch a local brand of the New York-based pharma giant’s oral COVID-19 therapy Paxlovid in China.
In 2021, the FDA cleared Paxlovid for at-home use to treat patients with mild to moderate COVID-19 who are at risk of developing the severe form of the disease.
The drug, comprising the protease inhibitor nirmatrelvir and the older antiviral ritonavir, has indicated an 86% reduction in the risk of hospitalization and death linked to COVID-19 in pivotal trials.
According to the agreement reached on Wednesday, the two companies will join hands to improve access to Nirmatrelvir and Ritonavir in China, CSPC said.
In 2022, Pfizer (PFE) partnered with local drugmaker Zhejiang Huahai to exclusively manufacture Paxlovid for the Chinese market, where demand for the therapy soared in December as the country emerged from its so-called zero COVID policy."
Who is this CSPC Pharmaceutival group, which will be launching Paxlovid for Pfizer in China?...It is a listed company..and I assume they are much larger than Eddingpharm.
Since "long Covid" is known to be a cause of inflammation in the heart, could Vascepa also be launched in China alongside Paxlovid?
Capt....PFE has already demonstrated an interest in Vascepa in Canada...and is the obvious candidate to promote, in China, a FDC with Lipitor(which currently has substantial sales in China)...in conjunction with Vascepa(which has been currently approved in China)....I would be surprised if there were not already some preliminary BO negotiations going on between PFE and AMRN.... and I'm sure PFE could, upon completion of a BO of AMRN, strike a deal with Edding to promote a FDC in China....The potential market would be enormous.
JR...Does this mean that we retail investors have to see Denner buying a load of Amarin shares...and then have to wait 6 months before a sale of the company...If the price is in the double digits, I would be OK with that scenario.
Nsleven ..The most common side effects include abdominal pain, diarrhea, nausea, and vomiting...plus less common side effects...
"Black, tarry stools.
blood in the urine or stools.
burning, "crawling", or tingling feeling in the skin.
difficulty with breathing when exercising.
fever with or without chills.
headache.
large, hive-like swellings on the face, eyelids, mouth, lips, or tongue.
muscle weakness."
However. it is propitious that the anti-infammatory effect is becoming more recognized as a factor in reducing CVD...This recent increase in understanding may spur appreciation for Vascepa's effect(MOA) on reducing CVD.
Capt....Your information makes me optimistic about the future of Vascepa in the U.K...
Omacor, a successful competitor to Vascepa, has been shown to be useless in reducing CVD....Nessen advised AstraZeneca to buy Omacor for millions of dollars and then spend many more millions for a study to prove its effectiveness in reducing CVD... only to see it fail...Somehow, this embittered Doc came to blame Vascepa for his mistakes and, ever since, he has been bad mouthing Vascepa, which was successful in doing what he had tried to do and failed...This unfortunate episode has caused a stain on the history of Dr. Nessen's career.
Capt....Low cost beats high efficacy every time.
Robin...As long as Vascepa is profitable in the U.S....and there is no pricing agreement for EPA in China, I do not expect an AG for the U.S.
With the present Amarin policy of cost cutting, I expect Amarin to show some profits in the next quarters and this should help the stock price to start rising from its present lows.
Ekman and PWO, whom he recommended for COB, had zero interested in Amarin...KM was doing a good job, but he had no interest in a sale of Amarin, which would have meant he would have to give up his position as CEO...Denner was put in a position where he had no choice but to take the actions that he eventually was forced to take... after trying his best and failing to compromise with PWO.
Then, KM besmirched his reputation by threatening to sue Amarin for terminating his position as CEO, which he had voluntarily resigned....He did a relatively good job under adverse circumstances, but then, IMO, he embarrassed himself with this final ploy.
PDude..."The pharmacy is listing the approved uses of IPE."
The pharmacy is NOT listing the APPROVED use" of IPE....but an INFRINGING use!
Perhaps Amarin can direct its infringement suit against the pharmacy(chain) and/or the insurance company covering the IPE for the UNapproved and infringing use for CVD.
In my entire long life, I have not been sued or sued anyone...But this Dr Reddy infringement seems to me, as a layman, to be ripe for a suite...Where is Marjac when we need him!
Nsleven...re Tats suggestion of Dr Reddy attempting to invalidate the CVD patents in response to an Amarin suite against them for their obvious infringing on Amarin's CVD patents...Hikma did already try to invalidate Amarin's CVD patent at the time Judge Du invalidated the high triglyceride patent in 2020... (IMO a grievous mistake by judge DU, brought on by Covington incompetence and a Hikma fraud on the court)... and EVEN SHE decided the CVD patents were valid.
I would welcome a failed Dr Ready challenge of the Amarin CVD patent in an Amarin vs. Dr. Reddy infringement suite...to help the court determine what compensation should accrue to Amarin for the Dr Reddy infringement of the Amarin CVD patent.
Almost all of the well known cardiologists at the 2013 Adcom were NOT impressed by Jelis and INSISTED on completion of the R-IT study BEFORE they would approve Vascepa for CVD!
ramfan.."the insert describing what IPE is would not be considered infringement because they would claim it's just educational."
YES...It would be EDUCATING pharmacy chains and insurance companies to infringe on Amarin's CVD patent!
Capt...I assume that this explanation by Dr. Reddy of the benefits of Vascepa was cleared by their legal department...but I would still like to hear, in court, how Dr. Reddy attempts to explain how this statement is NOT an infringement on Amarin's CVD patent.
With small pharmas, the SP is largely
determined on prospects
for future revenues...
with large pharmas, the SP is largely
determined on prospects
for current revenues...
The market is sending Amarin a message
of no confidence for future revenues.
This explains why Amarin is currently undervalued and why it makes sense for Amarin to sell to a BP.
Amarin has current revenues...with prospects for future revenues from Europe and ROW(including China) plus a future AG and FDC for the U.S. and ROW.
Amarin could have named their epa drug Vascepa CV and avoided the high triglyceride hassle.
At the Goldman C.C., Berg, when asked about an FDC, mentioned that Amarin was "waiting for feedback from regulatory bodies".
This comment from Berg made me speculate about the following...
1. Amarin has already discussed an FDC with the FDA
2. The FDA has previously made the point, during the 2019 Adcom, that Vascepa can(or even should) be used in conjunction with a statin...so I see no reason why the FDA would balk at approving an FDC.
3. The main reason for Amarin holding back on a FDC now would be the cost to manufacture and market it.
4. The cost to consumers for an FDC could be little changed from the cost of Vascepa.
5. An FDC would not lower the market for Vascepa, but instead, it would advertise the notion to patients and Docs that Vascepa (or an FDC with Vascepa plus a statin) is effective for reducing CVD....and, as a result, stimulate the use of both
KIWI...About BCS Annual Conference
Monday 5 - Wednesday 7 June 2023
Manchester Central, Manchester, UK.
Theme: Future-proofing Cardiology for the next 10 years
rmb...Lasers were not in use for cataract surgery when I retired, so I will be speaking to your question as a layman...Lasers can help with corneal incisions and can help with incisions in the anterior capsule of the lens, which is then removed as a part of the surgery to remove a cataract...Neither of these methods were discussed with me by the surgeon in my case when I had recent successful cataract operations in both eyes at the Mass Eye and Ear Infirmary in Boston...in separate day care procedures two months apart...I had retina specialists standing by in case complications developed during surgery, requiring a vitrectomy, which thankfully didn't happen.
If you want further information about my cataract surgery, E-Mail me at..EFG0234@gmail. com.
KIWI...The difference between innovations in the corporate word and in the medical world is that profits in the corporate world are directly tied to these innovations...For Doctors, innovations help patients,, but they don't necessarily do much to help the Doc's income ...and Docs are always dealing with the fear of malpractice suits when they use a new method of treatment...even if that method has been proven scientifically to be effective...Most Docs want other Docs to lead the way in using a new treatment on patients....Once they see that happening, they jump on the band wagon...Then they have a fear of malpractice if they do not use it.
This happened with the introduction of phaco-emulsification of cataracts, which initially lead to many lawsuits, but which are now the standard procedure for cataract operations.
from the Goldman C.C.....When asked asked about an FDC..Berg replied..."that's still something that we're working on."
I'm afraid an FDC will have to wait for a BP that buys Amarin.
Denner is negotiating to sell Amarin to a BP...Discussing the details of his negotiations would be neither wise nor helpful....These negotiations always take time...There are some, who are unable to be patient... but for those , who can wait, I believe Amarin will sold at a much higher price than where it it is now.
Blame Judge Du or Covington or Kennedy for the present need to sell...But don't blame Denner.
IMO Neither Ekman nor PWO were interested in selling Amarin, but just milking it.
IMO the importance of ordinary board members is overrated...
The loyalties of board members are in the following descending order...
1. to the COB
2. to the other board members
3.to their own reputations
4.to their friends in business
5. to the shareholders
ORBAPU... on whether the BRAVE study is blinded...
An important part of the study is cognitive performance...
The study specifies" Time Frame: 18 months cognitive performance"
IMO the examiners for this part of the study would be difficult to be blinded...unless the cognitive evaluation were done by a series of questions to be given to patients for their written multiple choice answers...This would not be a very good study of patients' cognitive performance over the time period and I doubt this would be the chosen method for evaluation of cognitive performance.
The lab parts of the study could, however be blinded.
Nsleven...re the elongation of the Brave study..."Enrollment:150 [Anticipated] 131 [Actual]"
The sample size was reduced slightly, but the study was extended for 2 years.
Nsleven...re Brave study
"Primary Completion: "April 2021 [Anticipated] September 29, 2023 [Anticipated]
Study Completion: April 2021 [Anticipated] September 29, 2023 [Anticipated]"
The 'primary completion' date and the "study completion date' are now both both 'anticipated" to be September 29, 2023
My understanding of this change of dates means that this study was extended for over 2 years...Imho these scientists, who have dedicated themselves to finding solutions for Alzheimers, would not have extended the Brave study unless they were seeing some good results, but still waiting for statistical significance(which is unlikely to be achieved due to the small sample)...but, even without statistical significance, the FDA could approve a drug like Vascepa for AD, since it has a proven safety record... if it is case that the results are trending positive in a disease which has no really good alternative treatments.