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Another ambiguity: In our TD Ameritrade account remaining, the Latest Earnings Announcement is set for today, 4/15/2024, but it sets the Upcoming Earnings Announcement as 4/18/2024. I gather 4/18 is correct.
Iran’s drone attack against Israel has begun, per news alert just received.
Beamr(BMR) is one of the early partners of NVDA mentioned in your post. NVDA shareholders should investigate BMR’ s website and PRs to see the image reduction technology that BMR brings to the table to enhance the share value of NVDA. We hold 600 shares of BMR, currently quoted at $6.20/share. We also hold 755 shares of NVDA at a split-adjusted cost or basis of $4.3115/share, purchased over a decade ago. Ready for another NVDA stock split.
Looked at ALPN very early this morning but, before I was able to accumulate funds in IRA to buy, it had already advanced in share price to near acquisition value. Gave up on what looked like a good play—will look at the other one over the weekend.
Some of us will remember the essentially “free advertising” Amarin obtained when the top-line and final data results from Reduce-It clinical trial were released in 2019-2020. Long stories with video interviews of Amarin’s CEO, Dr. Bhatt and various other knowledgeable cardiologists and endocrinologists were featured in the Washington Post, New York Times, Wall Street Journal and Bloomberg(Vascepa “works”, said JT), among many others. Prospective patients and prescribing doctors read those stories.
I am confident that Amarin management and BOD, and Sarissa/Dr. Denner will find a timely way to make those publications aware of Vascepa’s new CVD risk reduction and other disease treatment data that Amarin has accumulated since, particularly the data released this past week at the ACC scientific session—why and how Vascepa “works.”
Not only “what they are generic for”, but “what they are not shown with evidence to be generic for” would be better, IMO, in light of the facts of this case. The fact that FDA has approved the generic for one indication but has not approved the generic for another, second indication should be part of permissible conduct to escape infringement.
New York Times reports a FAA whistleblower investigation re design flaws in Boeing Dreamliner.
Thanks for the link and “dialog” between you and jfmcrr. My PCP, a former NIH research physician, prescribed tadalafil for me a few years ago. Both my retina specialist and ophthalmologist were happy to see it on my med list also after my cataract removal. I have no cardiologist that I regularly see.
I’ve read a report that the plane involved was manufactured by BA in 2015, in service for 9 years. This shifts the Denver incident to LUV(Southwest) maintenance.
New investigation initiated against Boeing after engine cowling fell off 737-800, hitting wing tip, Denver incident today, per Reuters.
dewophile, I didn’t realize the above link is a duplicate of what you posted, and forgot that when I read NEJM w/o our subscription copy in front of me that I need our password to read the entire text. Our local public library does not subscribe to NEJM or Lancet, but the librarian will be happy to provide an on-line view if I pay a fee. Is Google Scholar to be included in the new subscription-based service that Google’s CEO said will soon be introduced(CNBC-TV a few days ago)?
DOI: 10.1056/NEJMoa2312323
Above is from NEJM that I have read.
I would advise TD Ameritrade to replace the quotation I see with the full quote you see from the Webpage. That would remove an ambiguity that is adversely affecting CDMO share price, IMO. Have you contacted CDMO CEO and BOD regarding this ambiguity? I am an old shareholder that perhaps should have immediately known that “Which We All Knew.” I didn’t. Would new shareholders know? Would market makers and short sellers take advantage of the ambiguity to keep CDMO share price low?
At the very top of a TD Ameritrade CDMO stock quote, I get a notice that reads:
“Common Stock Status Alert: Delinquent”
I have a question; the answer could affect everyone here. If CDMO has paid the delinquency debt due, why am I getting a delinquency alert from TD Ameritrade today? Is TDA delivering false information that is affecting CDMO share value?
biopa, for some reason(relating to a “hidden identity”) I can’t respond directly to your most recent message. Suffice to say, I think if you trace my name and posts on the Amarin message board you will have my current assessment of where we shareholders and Amarin now stand. In short, I am more optimistic. I will have a better assessment after 1) the decision and opinion of the CAFC is released, and 2) Amarin’s posters and abstracts are presented this weekend, particularly Sunday’s poster that ACC says I need a meeting key to open and read. Maybe kiwi or exwannabe have a key and can open it to post the text. 3) I have not read the text and claims of the new patent to be granted by EU authorities either.
Meantime I suggest you read the article appearing at elaine.chen@statnews.com. Dew Diligence provides a link at post # 251995 on the Biotech Value board. Ask yourself: Does this article relate in any way to the Phase 3 BRAVE clinical trial that is examining the effect of Vascepa as a biomarkers diagnostic of dementia and AD?
Amarin needs to increase the number of patients in the U.S. and the rest of world who are prescribed Vascepa to reduce risks from CVDs.
This week PLTR/ORCL and CDIO/Navierre have established a pair of separate collaborations that are designed to make AI-driven diagnostic algorithms for detecting patient risks of CVDs available to those patients who live in less-populated rural areas. Potential patients( e.g., those in wheelchairs that may have such risks) simply have not been driven/travelled to urban areas of USA to obtain the use of trained cardiology clinicians and complex/expensive imaging devices. We have seen here that trained cardiologists do/will prescribe Vascepa by email to pharmacies in urban areas for patients or caregivers to pickup.
I do. 1). I have not seen the text of AMRN’s answer/reply to DRL’s motion that the magistrate judge in Trenton ordered be filed by AMRN on March 28. Does anyone have the text of what Amarin said?
2). A brief summary: IMO, AMRN has the potential option of filing a new complaint in Nevada or Trenton(or an amended complaint) asking for relief in the form of restoration of the patents held invalid in Nevada to a state of validity. AMRN would rely on the gist of the “fraud on the court” arguments that we shareholders presented to both the CAFC and S.Ct. IMO, the quoted inequitable conduct/ethics Hikma/DRL used to invalidate the patents would wipe out any question/issue of res judicata or collateral estoppel raised by DRL or HIKMA . The 1940s S.Ct. Hazel-Atlas decision/opinion by Justice Black is controlling authority.
3). All judges today, IMO, appear to have remarked that Hikma’s product label, coupled with a website and/or a PR, actually presented a case/issue of whether Hikma had directly infringed the AMRN patents under 35 U.S.C. 271(a). We need a follow-up, like court-ordered discovery, on that point.
At this point, it would be helpful to know if the antitrust case in N.J. has been, or will be, consolidated with the patent infringement case against Hikma in Delaware. Where will it be consolidated? A 3 judge panel of Circuit Judges normally decides such matters.
Spouse and I were going to watch/hear in person. One of us mixed up the date, and she scheduled April 5. We are talking about rescheduling now. We’ll see how that turns out.
You have a correct viewpoint, CaptB. Appearance of PTO examiners in federal courts has declined to near nil since the Tetracycline days many decades ago.
We have seen TEVA importing IPE to those Florida and New Jersey locations as well as Vancouver and Seattle locations. You earlier told me that you were unable to trace where those East Coast shipments went after landing in port. Were those shipments sent by truck to AMRN’s capsule processing/finishing supplier in S. Carolina or stored for use in any TEVA processing facility in Fla. or N.J.? We have seen, I think, TEVA settle its Marine ANDA litigation early to obtain a more favorable time of entry into the market from AMRN versus other generics that did not settle.
I suggest some possibilities: 1) TEVA merges with AMRN, and uses AMRN’s patented finish process to ultimately send finished dosage forms(including those of Mochida?) to Asia. 2). TEVA knows of PFE sales of Vascepa in all of Canada. PFE merges with AMRN. TEVA sells and airships its imported IPE to PFE in San Diego for use in its bioreactor plants there or to other independent plants along the West Coast. Same result for PFE as related in 1) above.
CDMO’s CEOs over the years, even recently, have distinguished between early and late stage customers in earnings conference calls. Pre-clinical or Phase 1-2a clinical trial customers were referred to as early stage that require less quantity of material for testing for results. Smaller size bioreactors would be used to produce that material. Conversely, late stage customers— those whose meds are in Phase 2b or Phase 3 clinical trials—often/always need material/med quantities that are sufficient for commercial sale once FDA approves an NDA. Larger bioreactors would produce that med.
A few press releases about identity of early or late stage customers would help, I think
Does anyone have any comments on the abstracts and theater presentations posted by triple? Or is too early w/o full text?
Were there any previous CG Oncology 10Qs or other SEC filings referring to that agreement?
I don’t recall ever seeing/hearing that AMRN cardio-vessel protection business competes with that of SWAV; both want to reduce risk of CVDs in quite different ways. JNJ is reported to be in talks to acquire SWAV, whose current share price is $320/share. See WSJ on-line alert a 1/2 hour ago.
Reported that JNJ is in talks to acquire SWAV; current share price of SWAV is ~ $320/share, CDMO is ~ $6.80/share.
Replacing an earlier holder of the job who left or was asked to leave?
Let’s see what the magistrate does after receipt of DRL letter response to be filed no later than Thursday, 3/28/2024. It appears DRL now wants to amend its complaint in antitrust case in Trenton. Exhibits attached, perhaps a controversy involving a local rule. Further comment unnecessary now.
Include the 8 points raised in your original AMGN post as well in any answer/opinion you or anyone else chooses to give.
What about the conclusions drawn by Amarin’s presentations and abstracts at upcoming ACC Annual Meeting/Scientific Session in April? Don’t the conclusions presented in each of #s 1425-146, 1425-145, 1042–03, 1054-07 and 1020-09 present evidence-based findings contrary to the content of the 2nd paragraph of your post from AMGN? Vascepa was not yet used in a pill formulation, afaik.
See my post #251170. I continue to watch for the results from the use of Amarin’s Vascepa to diagnose the presence and quantity of biomarkers associated with PTSD, dementia and Alzheimer’s Disease in initially cognitively healthy veterans, ages 50-70. Study was completed last year. Results await publication in a peer reviewed journal some time “soon.” Whether those results manage to lift Amarin’s share price to a level substantially higher than present level remains to be seen. Some of the biomarkers are the same as are being used to measure activity of other meds. One is different: the quantity of IPE(icosapent ethyl or EPA) in blood serum, measured with, or against, time of treatment. Researchers will be looking at the what happens to the level of the other biomarkers, e.g., lpa -1, as time of treatment progresses to completion and whether the patient remains cognitively healthy having that level of IPE in blood during treatment time.
See pages A1, A10 of today’s WSJ. Sad story about a formerly successful S. Cal. lawyer afflicted some years ago with periodic episodes of brain hallucinations(bi-polar in that sense) that have left him homeless, off whatever meds he had been taking, and refusing treatment at last report.
Yes; I hope Amarin’s briefs refer to, and rely on, the magistrate judge’s recommended opinion/decision, and also point out that the FDA has not approved any Hikma sANDA to manufacture, market, sell or import a gV to reduce the risk of patients from incurring CVDs where the patient has triglycerides more/less than 500 mg/dl, or is diabetic with a family history of CVDs, all in accordance with FDA approval of V.
Ordinarily, no. Is Hikma a party in Canadian litigation? Lurking behind the scenes, no doubt. Neither Hikma nor Dr. Reddy appear to be involved as a party with Apotex in Canada. There is precedent in the CAFC and CCPA that what happens in foreign litigation between different parties on different(?) issues is of little or no moment here in the U.S.
But wait!! We have a magistrate’s decision in Delaware. I do not remember whether Hikma had a product use document(similar to any(?) DRL document in evidence in the antitrust suit in Trenton) that was in evidence and reviewed by the Delaware magistrate in finding for Amarin, overturned by Judge Andrews, now on appeal.
Now we know why Amarin filed that long status motion in Trenton to consolidate the Trenton and Delaware cases, amend its complaints and answers to complaints to add further parties, seek fact discovery from all/those parties, file expert reports, etc.(see lizzy or JRoon’s filings to review that motion). I recall that at least DRL has opposed Amarin’s motion.
Personally, I like the reasoning of that Canadian court on the basic issue of what 3-4 events can constitute inducement of infringement.
At near 87, I count myself as among the oldest of the old. But I seem to have retained most of my original mental acuity after retiring from 30 years of law practice and 25 years of government service in 1961-1986. One of CVDs or AD or being hit by a car will herald my demise, notwithstanding the Vascepa I have been taking under prescription since April 2013. You will find the BRAVE clinical trial for use of Vascepa as a diagnostic to detect early signs(biomarkers) of dementia and Alzheimer’s to be interesting.
What entity do you think is paying for those expensive TV ads?
Open one of the links, and you will see a photo of a group of people(2 or 3 sheiks in the group) standing in front of an OMAN Mental Health Center.
U. Wisconsin is listed as conducting research on early detection of AD and subsequent treatment. P.I. Cynthia Carlsson was selected by HHS to be the head of its scientific advisory board on AD.
Repeat of yesterday—some time same place. Drop in share price to $6.62.
Nexalin’s advertisements have been appearing on sports channels like CBS “March Madness” of late. Cf. The ads for Lucid Motors a few years ago. “Advertise it, and they will come”is the business theory.