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You have a long memory.
Novavax CV vaccination.
I'm in a similar situation. Multiple PFE vaccination and one or two MRNA.
Only have had CV once, and that was about 5 months ago.
I got the Novavax a few days ago. No reaction.
Nor do I have any strong feelings toward doing it.
Multiple Independent Cancer studies Data for IceCure cryoablates tumors quickly and with
minimal pain for Breast Cancer, Kidney Cancer, Lung Cancer, Liver Cancer impressive tops any drug for efficacy & safety data. Minimally invasive Platforms will become a new paradigm for medicine. FDA Panel Meeting in a few weeks FDA Approval for Breast Cancer expectedearlyy January 2025
IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction 96.3% 5 year Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer
https://www.prnewswire.com/news-releases/icecure-medical-reports-final-ice3-breast-cancer-cryoablation-trial-results-of-100-patient-and-physician-satisfaction-and-96-3-recurrence-free-rate-data-submitted-to-fda-requesting-marketing-authorization-to-treat-early-stage-b-302116526.html
Independent Study Results in Japan Demonstrate Zero (0%) Breast Cancer Local Recurrence 5 Years Following Treatment with IceCure's ProSense®, Adding to Continued Positive Data Published Globally
Terumo Corporation owns the exclusive distribution rights for ProSense in Japan for a 5-year term after regulatory approval,
Billionaire Victor Lee founder of Tencent owns over 50% of the IceCure Shares.
IceCure Medical's ProSense Cryoablation System (Video)
Gene therapy for sickle cell disease
https://www.nytimes.com/2024/09/16/health/sickle-cell-gene-therapy-kendric-cromer.html?unlocked_article_code=1.Mk4.G6Jx.YEbBz53pCfq5&smid=url-share
Re: What's up with RVNC?
On iHub's RVNC board, there is no shortage of speculation about what's delaying/inhibiting Crown's tender offer. Of particular note is 'iwfal's case d2) in #msg-175090952 because there's a clear economic impetus for such an outcome.
I haven't tried to handicap the outcome, but my own view of the situation is in #msg-175091770.
Would assume that Crown was aware of this as part of their due diligence process and included it in their valuation model, but crazier things have happened. Someone on the Crown team may have brought it up, but was overruled by someone who really wanted the deal. Not sure from an NPV standpoint, what this would do the deal valuation if revenue from this was included vs excluded. If they were using a synergy model on OPEX, then excluding the revenue would definitely lower the deal NPV. Any thoughts on the likelihood that this deal goes through?
FluMist now FDA-approved for self-administration:
https://www.prnewswire.com/news-releases/fda-approves-nasal-spray-influenza-vaccine-for-self--or-caregiver-administration-302254354.html
With the label expansion, Flumist can be administered by a healthcare provider or ordered through a pharmacy for self-administration at home.
The approval is for ages 2-49 (same as the prior label). The low upper bound of the age range (49) is due to FluMist’s containing a weakened, but live, flu virus.
OMIC receives $12/sh non-binding buyout offer from Tang Capital—besting Deerfield’s $10/sh (which was also non-binding):
https://www.globenewswire.com/news-release/2024/09/19/2949445/0/en/Singular-Genomics-Receives-Non-Binding-Acquisition-Proposal-from-Concentra-Biosciences-and-Tang-Capital.html
APLS—(-13%)—loses appeal of CHMP rejection:
https://www.globenewswire.com/news-release/2024/09/20/2949536/0/en/Apellis-Receives-Negative-CHMP-Opinion-for-Pegcetacoplan-for-Geographic-Atrophy-GA-in-the-EU-Following-Re-Examination.html
See #msg-174674733 for related info.
Yes- just going to post that same with some commentary
Desperation to protect their share.
LLY is killing them now and CagriSema may have too many side effect to be competitive. And they know several new promising NMER's exist (i.e. VK2735)
CRBP -57%, SKYE -45%—>collateral damage from NVO.
From the same NVO PR:
NVO- Monlunabant (an "inverse" cb1) looks like it has pysch side effects in phase2a. Unlikely FDA ever approves this drug if there is any question here no matter what the weight loss efficacy. NVO is down approx 5% as I post or about $30B in market cap.
Novo Nordisk A/S: Monlunabant phase 2a trial in obesity successfully completed
For a moment, i thought it was $ENTA.
another contributor to vaccine injury rates could be that there are more vaccines and specifically more than can be co-administered. If you are a side sleeper you may want both in the same arm, but you need a deltoid large enough to be able to get both and still not veer into a sensitive location in that arm
Vaccine injury:
Further thoughts FWIW: My operating assumption, given the apparent large increase in reported SIVRA (severe inflammation of shoulder joint (not just muscle soreness) after vaccine) is it's a combination of much more immunogenic vaccines combined with lax shot placement (reminder - I watched my pharmacist argue to inject at joint, not 2 or 3 fingers down). Lax shot placement wouldn't have mattered anywhere near as much when the vaccines were a lot less immunogenic, but now... .
And I don't expect the FDA to do anything about it until it's a scandal because vaccines are now politically coded - eg the CDC and FDA both behaved badly wrt COVID vax (CDC tried to prioritize Black's over elderly (and only reversed when the slides became public), and I watched FDA try to hide children vax data).
FTR - I favor vaccines. Strongly (eg I just got Novavax, will get pneumococcal soon). But no good comes of prioritizing social manipulation over data transparency. However Public Health has moved strongly in wrong direction.
VNDA- Vanda is a bit miffed at the FDA. They say their data supported approval and the FDA ignored it. They are also a bit put off by the length of time the FDA took to respond.
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
https://finance.yahoo.com/news/fda-declines-approve-vandas-marketing-110000957.html
Vaccine shoulder injury
muscle soreness is obviously common, but it sounds to me like you got the shot too high in the shoulder - that kind of injury is not that rare and in fact happened to my mom who years later has shoulder pain. Glad you are feeling better but just an FYI for future that it may be the administration and not what's in the vaccine
I won’t get flu vaccine until early October. That timing will protect me from trick-or-treaters getting me sick but the six month window of maximum protection should carry me through February.
SHOULD HAVE GOTTEN THE COVID BOOSTER when I first saw it offered at the local pharmacy. Thought to myself, “I’m busy, I’ll come back later.”
Then, BAM, I got Covid for the first time in early September.
10/16/2023 Is Novavax COVID Vaccine_Better_Than_mRNA Vaccines? What We Know So Far
Novavax’s protein-based vaccine is the latest FDA-authorized COVID booster available this fall. Here’s what you should know
https://www.scientificamerican.com/article/is-the-novavax-covid-vaccine-better-than-mrna-vaccines-what-we-know-so-far/
I don’t have a strong view but I think nvax is still directed at jn1 while mrna vaccines have been updated to kp2 which is the predominant strain now. I recently got flu and pfe same day (nvax wasn’t an option) fwiw
Novavax reduces viral load by 2.78 log10, while the Moderna vaccine was 2.12. The log10 scale is 10x for each step, indicating Moderna reduces viral load by just over 100x, and Novavax reduces viral load by over 600x. No significant reductions seen for others. pic.twitter.com/gMepaVZkr4
— Daniel Park (@Daniel_E_Park) September 14, 2024
Re: Novavax
This is the first time that I've seen it offered at our local CVS, they offer Moderna, Pfizer and now Novavax covid vaccines. I've been alternating Moderna and Pfizer but I am thinking of going with Novavax. Although I'm not convinced that there's much benefit in getting my 6th or 7th booster (I can't keep track) plus natural immunity from one or two infections, beyond the relatively short period the antibodies hang around.
Anyone have a strong view on protein v. mrna vaccines?
agree totally - probably feel like crap with that amount of adjuvant
GSK—Phase-3 trial co-administering Shingrix and Arexvy meets_primary_endpoint:
https://www.businesswire.com/news/home/20240917307121/en
Co-administration of these two vaccines may work from an immunological standpoint, but I wouldn’t want to try it!
Interesting comments by the Novartis CEO Vas Narasimhan on obesity market.
Novartis not joining the ‘frenzy’ of weight loss drugs, CEO says:
Small molecules have typically shown off target effects. Asceletis preclinical data looks promising but they will need to show GI effects that are not "consistent with the incretin class" or worse to have a market impact.
As a side note, this is the Chinese company Viking sued for stealing trade secrets on VK2809 in early 2023. VKTX alleged that Ascletis received confidential information about VK2809 while discussing a partnership as part of a confidential disclosure agreement in 2016 and 2019. The company said that Ascletis then abruptly ended the talks after reviewing the confidential information and its Chief Executive founded a sister company, Gannex Pharma, to develop a rival therapy for NASH. Ascletis has since halted their NASH compound development so the suit is now moot.
Lots of NASH companies in the obesity race now (e.g VKTX, ALT) as they presumably felt GLP1's had promise in that indication only to pivot.
See https://www.evernorth.com/advocate for complaint and further information. My own views, in part, are posted on the AMRN board earlier today. Any resemblance between the Titanic and an iceberg is purely coincidental.
Close to 100%, IMO.
Novo Nordisk says Ozempic a 'very likely' target in next Medicare drug pricing talks
A top executive at Novo Nordisk (NVO) warned Tuesday that the company’s diabetes therapy Ozempic will likely be selected for the next round of Medicare drug pricing negotiations, which aim to seek discounts for blockbuster meds supplied to the federal healthcare program.
“It is very likely that Ozempic will be part of negotiations in the coming round, and we’re ready for that,” said Ulrich Otte, Novo’s (NVO) senior vice president of finance & operations at Cantor Global Healthcare Conference in New York.
A year ago, the U.S. Centers for Medicare & Medicaid Services unveiled the first ten drugs targeted for the initial round of pricing negotiations.
https://seekingalpha.com/news/4150413-novo-nordisk-ozempic-targeted-medicare-pricing-talks
I find it hard to believe that Cigna/Express Scripts wants to go through the legal discovery process that precedes a trial.
Cigna, Express Scripts and its sub sue FTC today in Missouri.
The complaint raises issues re a July 2024 Report published by FTC about high drug prices, and asserts the FTC has exceeded its power in issuing the Report.
https://www.prnewswire.com look for Express Scripts
www.wsj.com
Reuters, Bloomberg, Fierce Biotech Health also cover the issues raised in the 30 page complaint.
Teoxane has_the contractual right to_end_its_agreement_with_RVNC_if_there_is_a_change_of_control; from Section 16.4 (page 66) of the Teoxane Agreement filed with the SEC as Exhibit 10.43 to RVNC’s 2020 10-K:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001479290/000147929020000042/rvnc1231201910-k.htm
Hong Kong-listed Ascletis Pharma has oral small-molecule GLP-1 agonist that can also be dosed monthly by subcutaneous injection, according to the company:
https://www.prnewswire.com/news-releases/ascletis-enters-the-obesity-drug-space-with-announcement-of-two-ongoing-us-phase-i-clinical-trials-utilizing-its-small-molecule-glp-1r-agonist-asc30-for-both-once-monthly-subcutaneous-injection-and-once-daily-oral-tablet-for-the-302249778.html
If they do, it will have to be disclosed in the SEC filings for the tender offer (assuming the tender offer happens).
SEC filings for a tender offer are rather similar to those for an IPO in terms of the required disclosures.
I still wonder if some RVNC insiders have an undisclosed position in Crown.
It depends why the tender doesn't go through. If it's because Crown lacks the funding or otherwise fails to close when 50% of the shares have been tendered, Crown pays $43,140,000. If it's because less than 50% of the shares are tendered and not withdrawn, Revance pays $28,760,000.
Does Crown face a penalty if the tender doesn’t go through?
The merger agreement contains as exhibits equity and debt committments sufficient to fund the tender and merger; the equity committment is guaranteed by various Hildred Capital funds. The actual committments are not attached to the merger agreement filed with the SEC, available here: https://www.sec.gov/ix?doc=/Archives/edgar/data/0001479290/000119312524198448/d876039d8k.htm
Here is a bit of background on Hildred and Crown from a March 2024 article in the WSJ:
What do you know about Crown and it's ability to carry out this transaction?
Comments on RVNC’s price action today:
#msg-175091717
#msg-175091770
IBO IPOs 1.73M* shares @$3.00:
https://www.globenewswire.com/news-release/2024/09/16/2946794/0/en/Impact-BioMedical-Inc-Announces-Pricing-of-Initial-Public-Offering.html
KAPA IPOs 1.78M* shares $4.00:
https://www.globenewswire.com/news-release/2024/09/16/2946812/0/en/Kairos-Pharma-Prices-6-2-Million-Initial-Public-Offering.html
PFE phase-2 cachexia trial meets primary endpoint—data presented at ESMO and published in NEJM:
https://www.businesswire.com/news/home/20240913347614/en
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