Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Stockrafter post #8410, and read all posts from that date to today for other links and discussion. A few may be worthless, like cubflyer here.
Take a look at HALO’s pipeline. There are some slides, including a slide from the gov’t, that appeared on the IHub HALO board yesterday, I think. Enhanze at work among clients.
A security outfit like CrowdStrike, CRWD, should be able to identify the individual or group that did the hacking—within days, per yesterday’s interview with its CEO. What’s the purpose of the hack? Customer data?
For a hint at direction insurers may be going, the CVS where my prescriptions for Vascepa are filled no longer stocks generic V and my GEHA insurance, managed by Caremark, will not cover generic V. See also the posts beginning with JTFM’s post #14794 to last about Medicade, various BCBS plans, on the ANIP IHub board with respect to preference for a different med.
Cold Spring Harbor scientists might disagree with you, as DMC8’s post suggests. Note that the FDA itself has not approved any generic V for reduction of risk from CVDs as opposed to ANDAs for triglyceride reduction.
A more aggressive WARF might apply. At least Vascepa is not like Ivermectin. NVDA GTC with CEO speaking about B100 chip in about an hour. Investors know about the chip. Doctors may be becoming more aware of Vascepa. What makes you think any doctor would prescribe a generic for AD/dementia?
At age 87, I guess I qualify as among the “oldest old.” My mother died in 2000 at age 92 from effects of 2 falls, inability to exercise, and resultant dementia. She did not know/recognize either my brother or me when we visited her in a Montana hospital.
I think Marjac would confirm that I was around “at the time.”
You might read the petition for certiorari we filed in the Supreme Court on behalf of Amarin shareholders/intervenors.
I suggest you read what you quote again to answer the question you posit.
The Veteran population is at RISK. The population studied has not yet actually developed the AD/dementia condition at study start or during the trial.
It appears to me that the FDA could approve the use of Vascepa to treat AD/dementia by way of its statutory authority to approve the use of medications on a “right to try” basis, in light of the biomarkers evidence supporting such use already extant that you and kube post. Confirmatory trials confirming such use would then be initiated.
ziploc, your observation coincides with MRK’s mixed results at the BPAI and my own observations when I was a member of that Board in 1983-1986 before leaving to enter private practice. But that was long ago. The Undersecretary of Commerce annual report to Congress, budget hearings, may still have statistics on Board results in reexamination proceedings.
One of my last, and longest, cases as an expert witness was a jury case in Arizona. I had been deposed 4 times over a period of 25 years. The jury heard testimony on who was the 1st inventor of the subject matter in the claims of the plaintiff’s patent. The jury found the accused infringer’s witness was the 1st inventor. The Board had found likewise. Both asserted inventors had testified by way of deposition before the Board. The accused infringer’s inventor witness testified at trial. The jury heard no new testimony from the inventor named on plaintiff’s patent because he was dead. Both parties submitted documentary evidence to support respective inventor testimony. I think the parties settled.
See also #422127 and subsequent replies thereto.
Good. In light of the first sentence of your post, others here may not know or have recognized that counsel for Merck in the Keytruda patent litigation with JHU is the same counsel that Amarin is using in the Amarin v. Hikma matter now on appeal to the CAFC. I wonder, like you, why Amarin has not asked for reexamination of its 4 patents in the PTO before the Board of Patent Appeals and Interferences. The procedural effect of FRCP Rule 60(d)(3) “at any time” seems equally applicable in both the Federal Courts(Hazel-Atlas case) and BPAI. But the timing and enhanced litigation cost may not be appropriate in light of other matters Amarin is considering. See letter to shareholders and CEO Holts remarks at JPM.
Your memory is better than what I forgot had been mentioned several times by Amarin CEO Holt in the transcript of remarks from the JPM conference. Thanks, RMB.
Will China require confirmation trials in patients of Chinese ancestry, not European ancestry? I forget how many Chinese travelled to that island location near Guangdong to be treated with Vascepa for CVDs.
Ilovetech, I am hampered in responding to your question because your #422218 link failed to provide any Merck litigation links. Merck’s been involved in numerous PTO reexamination matters dating back ~ 2 decades. Do you mean the Keytruda patents litigation referred to here?:
BeckersHospitalreview.com
The resolution is already present in post #/…’247, my original response to you. No waiting. I always will pay $15 co-pay in that particular CVS you called w/o a new coupon, may be $9 if I contact Amarin and get a new coupon. But do you have my gov’t insurance plan, GEHA? Note the most recent posts of DMC8 and CaptBeer re Vascepa becoming “preferred” drug to treat CVDs and for “longevity”.
Rmb, it’s the same Yahoo article that ramfan posted earlier today.
I see where physicians who not aware of Vascepa seem to be prescribing generic rapamycine for $sums that far exceed the yearly cost of Vascepa I pay. Vascepa should be able to compete, even off-label, with generic R and/or V. Your logic and rationale are sound. At near age 87, I am not thinking of using generic R or V. It is ironic that I was prescribed V, off-label, in 2012-2013.
DMC8, it might be worthwhile to post by copy/paste the pdf of the pictures/drawings and text of the short editorial article here as a record of what is going on diagnostically in the CRC test, if you can. I can’t tell if anybody actually did read any of the 4 NEJM articles I posted. I see some evidence that Bayer may be changing its business model to account for the potential disappearance of Cologuard from its sales picture, to be replaced by the blood marker test when/if FDA and EU approve it. Two new indications for Vascepa might result—treatment of CRC and metabolic syndrome are the potential new indications, IMO.
1500 Wilson Blvd in the back of the Target store location. There is a new, much larger CVS that recently opened a bit further up the hill on Wilson. We have not explored what is available in the new CVS. Spouse and I speculate that the rented space that CVS has in Target might close. Cut costs as it is almost across the street from the new Wilson CVS location though Target itself is large and likely provides the same/more goods(like electronics and extensive grocery items) that may not be available in the new CVS.
I wonder how long we wait for that $80?
And I thought the vet bills and subsequent urgent care bills for imaging our cat with a cat hospital stay of 3 days and nights were high. She was morose and ate nothing for quite a few days. Some surgery and appetite stimulating cream applied to her ears did wonders. Our cat is back home now happily eating/snacking and sleeping away. The vets at those 2 locations know what they’re doing.
I paid $15 co-pay at CVS also for a 3-month supply of Vascepa. Both of us should see if Amarin still has a coupon for $9 co-pay, and renew it if they do so we can present the new coupon to the pharmacist. Otoh, Amarin may have increased the coupon price to $15 co-pay. Inflation?
One of the clinical trials involving Vascepa is in CRC—Colorectal cancer, if I recall correctly. In the NEJM dated March 14, 2024, there are 2 original articles and 2 editorials dealing with the main article “A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening” at page 973.
DOI: 10.1056/NEJMoa2304714
DOI: 10.1056/NEJMe2311101 is one of the editorials titled “Science Behind the Study” at page 1047.
See also DOI: 10.1056/NEJMoa2310336 and DOI: 10.1056/NEJMe2400366
Did the FDA approval AH of MDGL’s MASH/NASH drug trim AMRN’s sails/potential sales?
I don’t think I said that, ilovetech.
First, look at the population of 600+ District Court judges. Some, like Judge Andrews in Delaware, will handle the usual patent infringement case readily. Experience!! The PTO does not deal with infringement issues, and validity issues(if simple) he will deal with. Complex validity issues coupled with a docket filled with, e.g., higher priority criminal cases(Speedy Trial Act) may be another story. Then, many judges will order the parties to seek reexamination of the patent(s) in the PTO to gain views and experience on patent validity of the 200+ experts on the PTO Board of Patent Appeals while they deal with priority cases on their docket.
dogn, I suggest that all here look for the Corporate Call and Q4 update for March 13, 2004 at Investor.Sangamo.com. I found this presentation on the ANI Pharmaceutical IHub board at post #14792. The 42 slides(reflecting preclinical research in animals) are impressive. (My hope is that the researchers at the U.Wisconsin have completed or are currently assessing the cells of human patients in the Amarin-funded BRAVE trial using the same or similar technology). The SGMO cell images appear to be enabled by NVDA AI technology/chips, and have caused SGMO to change its business model to focus on development of technology in 4 areas of the brain, e.g., prion disease and Alzheimer’s disease, as well as novel chronic neuropathic pain therapeutics. PFE is financing the preclinical Prion Disease and AD area so far, and Alexion and Takeda are partners in 2 other areas
That last trade at $0.90 was deliberate on my part, sleven.
With my insurance being managed by PBM Caremark at my local CVS, my latest co-pay continues to be $15 for a 3 month supply of Vascepa, prescription filled 2/27/2024. I have no reason to ask for any generic Vascepa to fill that prescription. Generic Vascepa is no longer available or covered at my local CVS.
From memory, looks like EPA v. DHA.(?)
Maybe I do not understand the Device Specifications written on the instruction for use form enclosed inside the product box. There it says, under Expected Service Life:
…..Up to 720 hours (on/off capability)
…..Up to 168 hours (continuous)
I expected 168 hours but actually received ~ 720 hours, 1 month.
How long will it take Amarin to bring that MND-2119 based product to market, predicated on FDA approval of same? A new NDA? AdCom? A sNDA? Will PFE agree to sell a new Vascepa product form in Canada? How long will it take the U.S., the Canadian provinces, and the rest of the world to approve suitable/sufficient remuneration for the new Vascepa dosage form?
Biel extended the life of its Recovery product. Did Biel ever extend the life of its ActiPatch product?
I fell on my left hip over a month ago. No bone breakage. I went to my chiropractor about a month ago. He has adjusted placement of ActiPatch ring surrounding the sore/pain area on each twice a week visit, and yesterday the light went out after that MONTH of 24/7 wear. My M.D. spouse placed a new ActiPatch. I am now mostly pain free, and doing my best to develop a posture where I do not look down constantly. Lidocaine patch and Alleve capsules helped also.
See also #422108 and related posts and replies. Methinks Tats has ignored that conversation and effects thereof.
Wow! This proposed schedule in all cases filed by Amarin is certainly worth knowing about. I think I see where these cases are/might be going, and I see why Hikma et al are opposing this Amarin schedule. Has TEVA or Takeda said anything about new proposed schedule yet? The time periods in which fact discovery ends and Amarin may amend its complaints to include other parties will prove interesting to CaptBeer, Tats, you, me and everyone else if my speculation is correct. More later, if necessary.
This post raises questions whether Eastern CapitalKen Dart is now/will be collaborating with Sarissa/Alex Denner in raising share price of CDMO to higher/former level above $6.50.
Lost pacer account when I retired, and now depend on others. CaptBeer, DMC8, anyone else: Is there anything in that letter in the D.N.J. antitrust case worth knowing about? Please post text.
The status update usually enables the proposed schedule of future events in the case to become effective. End of discovery, filing of expert reports, arbitration schedule, trial dates, etc.
The claims of that Mochida patent are at pages 71-72. Most pages are devoted to numbered paragraphs of the specification that support the claims. Thanks for the link.
I still wonder whether the present CAFC appeal will settle before oral arguments in early April. Recall that the magistrate judge in D.N.J. has set a date for Doctor Reddy to update the status of the antitrust case that expires soon, this week I think.