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.
NVAX - two slides on myocarditis. These are from the Novavax presentation at the advisory committee meeting yesterday and give some details on each patient.
https://www.dropbox.com/s/jnx16r44xk3flaz/2022-06-08%2016.30.23.png?dl=0
https://www.dropbox.com/s/srj76ik3s38ey9p/2022-06-08%2016.28.57.png?dl=0
These are screenshots of screenshots, there’s got to be a better way, but, for example, there’s evidently no easy way to create a link to a document in an icloud drive, as there is with dropbox.
NVAX - myocarditis. Right, one of the NVAX slides showed the details of the three cases of myocarditis during cross over. and repeated that consistent with background rate claim Since by definition there is no placebo control at that point, I suppose there is no group to compare to other than background rates.
It may that the Novavax presenters (mainly Filip Dubrovsky, who I thought was pretty good) grokked that the panel was going to vote for approval and that the myocarditis issue wasn't enought to derail that and decided they might as well hold that discussion for the FDA and labeling.
I confess I don't really have an informed view (you may ask how I could buy shares without such a view, fair question, but it's a relatively small position for me). I would expect a substantial share in jurisdictions where it is approved as a booster, such as Japan. Maybe 25% or more. The Japanese approval was fairly recent so I'm not aware of any market share data there yet.
I'm skeptical that many of the "vaccine hesitant" will change their mind and get vaccinated by Novavax. Clearly some will, maybe a few million in the US. Or perhaps the entire population of such persons testified in the public portion of the meeting today.
There's just so much data that could change things either way. I think that's one of the things that clearly bothered the committee, they were looking at data from more than a year ago, of the vaccine v. variations that don't exist anymore. But it shouldn't be too long before we have real world data v. Omicron.
Surprisingly little discussion, and not that much questioning. One of the "yes" votes (Bruce Gellin) was "conditional" on the FDA reviewing the totality of the evidence, meaning, additional evidence presented by the company in response to qiuestions, which seems odd to me since that data was favorable.
NVAX - VRBPAC panel recommends the FDA approve the EAU application. 21 yes 1 abstention.
Here's the link to the NVAX FDA briefing documents: https://www.fda.gov/media/158912/download
Depressing news.
Any lithium battery recyclers worth investing in? I started looking at Li-Cycle Holdings (LICY on the NYSE). Admittedly, it is an Ontario corporation, but it got a cash infusion from a Korean large battery manufacturer (LG Energy Solutions) recently. But I've only spent 5 minutes looking at it.
And it’s now down less, on a percentage, than EOLs.
EOLS is down a bit more than 5% as I write this (whereas RVNC is down about 7.5%) so perhaps it is just possible belief that the Botox market will suffer in a recession or otherwise.
The UK Panoramic antiviral study described here dies not explicitly exclude vaccinated https://www.panoramictrial.org/participant-information
And this discussion implies it will include vaccinated
https://www.news-medical.net/news/20220412/Thousands-more-vulnerable-patients-are-eligible-to-receive-the-UKe28099s-second-antiviral-for-COVID-19.aspx
Not directly related to the 5 v longer question but I find it difficult to believe they any such trial would be permitted to exclude vaccinated or previously infected (as EPIC-SR now does) given that that’s got to be a large percentage of the population Paxlovid is being given to in the real world.
<<Will OBGYNs oppose adoption of this product? It has the potential to reduce billable office visits.>>
Maybe it reduces visits but doctors can charge for monitoring or reviewing the data and that could be more profitable in volume.
Re: BYND
The party is over, you said. — good call
https://www.wsj.com/articles/beyond-meat-shares-drop-as-losses-widen-11652309241?mod=itp_wsj&yptr=yahoo
Re: NVAX
I guess the market heard your complaints and is offering the opportunity to buy at close to the low point at the open yesterday. At this rate, it won't be long before the stock trades at under cash. Having raised a chunk above $80 a share not that long ago, it must be somewhat tempting to buy back some at half that.
Novavax earnings: $203 million of earnings, $704 million revenue.
https://ir.novavax.com/2022-05-09-Novavax-Reports-First-Quarter-2022-Financial-Results-and-Operational-Highlights
Somewhat lower than consensus, deliveries slower than expected. Still guiding for 2022 revenue of $4-5 billion. Market doesn’t believe them or something else as stock is down 18 percent after hours, down 28 percent on the day. Didn’t have the stomach to listen to the conf call yet.
Re: Paxlovid
Someone on Twitter (Dr. Path Hero) corrected one of my tweets in which I described the EPIC-SR trial and noted that the protocol for the Pfizer Paxlovid "standard risk" trial was changed. Whereas the press release I previously cited to (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results) said that the trial would enroll vaccinated people with risk factors, the protocol at https://clinicaltrials.gov/ct2/show/NCT05011513 changes that.
Re: NVAX
In this recent Fauci presentation, he says at 19:40 that NVAX is “looking very likely for an emergency use authorization in the near future.”
Re: NVAX, other vaccine manufacturers.
NVAX up almost 14 percent as I write this, FDA finally convening a VRBPAC meeting to discuss NVAX EAU June 7. Followed by three more meetings June 8, 21 and 22) to discuss MRNA and PFE applications for under 5. I’m hopeful that that means the manufacturing issues were resolved to the satisfaction of the FDA.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-tentative-advisory-committee-meeting-schedule-regarding
Re: RVNC/ABBV
This sounds like a downside as well, frim that promotional article I linked to:
Is it painful? Some patients may require 2% lidocaine with epinephrine 10-12cc total injections. Most patients report about three days of downtime. Patients should be instructed to use petrolatum occlusive for 24-48 hours after the procedure. Patients heal without evidence of scarring since the needles are so small. There have also been virtually no adverse effects
I’m not sure how much to infer from the addition of NVAX to this NIAID sponsored booster trial.
https://clinicaltrials.gov/ct2/history/NCT04889209?A=27&B=28&C=merged#StudyPageTop
Micro-coring —
What is it? Also known as fractional tissue extraction or micro-exisional skin removal, dermal micro-coring involves making tiny punches in the skin using an energy-free, small-gauge needling device (Cytrellis*). Similar to those achieved with punch biopsies, each micro-core is less than half a millimeter in diameter; they are placed in a fractional pattern across the mid- and lower face, scarlessly removing up to eight percent of the total surface area to shrink and tighten the skin and stimulate collagenesis and elastogenesis. You can see the cores close through optical coherence tomography before patients leave the office. ..
https://practicaldermatology.com/articles/2020-oct/dermal-micro-coring-101
CLF down about 9% today, presumably in response to sharply lower iron and steel prices due to lockdown fears in China. https://www.marketwatch.com/amp/story/iron-ore-steel-futures-slump-on-china-lockdown-fears-271650858524
However, CLF seems less exposed to this than others given their fixed price automotive supply contracts.
CLF — And yet, after trading sharply up for a while, it’s now slightly down. Tough market. Perhaps investors are less optimistic about the needs of the automotive industry than LG.
Having told some shareholders such as Marthambles that they would update via 8k when the letter was received, seems like they had no choice.
NVAX - stock may also be reacting in the other direction from this suggestion that FDA wants more manufacturing data in a Meg Tirrell interview with Dr Doran Fink:
FDA on Novavax #covid19 vaccine review: “This is an incredibly complex review process that involves review of not just clinical data but also manufacturing data that will be needed to make a determination about emergency use authorization… (3)
“and once we have all the data we need to complete our review, again, we will work diligently to present those data to our advisory committee and in a timely manner in order to make a decision.” (4)
“and once we have all the data we need to complete our review, again, we will work diligently to present those data to our advisory committee and in a timely manner in order to make a decision.” (4)
— Meg Tirrell (@megtirrell) April 20, 2022
The pessimist case is that they can’t decide whether it is a complete response and can’t decide whether to say yes or no. Seems unlikely, it’s not a decision on the merits, as I understand it, just whether it addresses the issues.
I guess the CDER Manual of Policies and Procedures that jcrem linked to (http://www.fda.gov/media/72727/download) stating that the fda will acknowledge receipt of the resubmission within 30 calendar days and say whether it is or us not a complete response is a “policy” and not a legal requirement.
Re Paxlovid - your friend’s report of no symptoms within 12 hours is encouraging. In the EPIC-SR (standard risk) trial, Pfizer reported “ the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days, as compared to placebo, was not met.”
Of course, that’s standard risk patients, your friend is high risk. It may be that for standard risk patients placebo is a harder comparison (especially if lots of them were vaccinated).
Also, that’s a tough endpoint, sustained alleviation of all symptoms except for one minor one didn’t cut it.
We’re still waiting for the final analysis of the Paxlovid EPIC-SR (standard risk) trial. Interim results were reported in December 2021, I’m a bit surprised its taking so long to get the final analysis. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results
Meanwhile its being prescribed to a population much larger then the EPIC-HR trial covered (high risk, unvaccinated). And we don’t know whether, for example, it reduces incidence of long COVID.
Approvals ex US keep on rolling in but no one seems to care or perhaps it’s all priced in.
TOKYO, April 18 (Reuters) - A Japanese Health Ministry committee said on Monday it has approved Novavax Inc's (NVAX.O) COVID-19 vaccine, setting the stage for full approval of the country's fourth shot for the coronavirus.
The Japanese government has agreed to purchase 150 million doses of Novavax's recombinant protein type vaccine, which is to be manufactured domestically by Takeda Pharmaceutical Co. (4502).
https://www.reuters.com/world/asia-pacific/japan-health-ministry-panel-approves-novavaxs-covid-19-vaccine-kyodo-2022-04-18/
Agreed. I was commenting on whether they are valid/legal, not whether they are sound from a corporate governance viewpoint.
Poison pills have been around for 40 years now. Their validity was unclear when Wachtell Lipton first introduced one in 1982 but they were held valid in Delaware in 1985 and I would guess that thousands of US companies have adopted them.
Yes, they do discriminate between the any shareholder acquiring more than the threshold without Board consent and all other shareholders — that’s their point. By so doing, the theory goes — and there is some evidence supporting the claim — they encourage or force higher bids.
I would still like to see an affirmative statement that the resubmission was accepted. I assume the risk of an issue is low, presumably the lender reviewed all that carefully, but RVNC record is not unblemished.
Right. Normally they expire on a Friday but Friday is a holiday. Anyway, still tempting but I will resist.
The 20 options expiring today have a bid-ask of .55 - .85, with 491 on the bid side, if I understand the screen correctly. Very tempting, if called at that 20 the return is almost 10 percent in one day.
But I haven’t held this piece of dog meat this long to basically break even!
Why is it called pig iron? I wondered…
Corrosionpedia Explains Pig Iron
The common mold shape that is used for ingots was with a branching structure formed within sand. This configuration is similar to the look of a litter of piglets suckling on a sow. Once the metal has hardened and cooled, the little ingots or "pigs" are broken into a thinner runner, hence the name "pig iron."
https://www.corrosionpedia.com/definition/880/pig-iron
Unfortunately, I own a bunch of OCUL as well.
It also contains the preservative benzalkonium chloride (BAK), fairly common in glaucoma drops but not something I want to put in my eye when there’s an alternative. For that reason, many drops come in individual preservative free formulations.
That’s one of the advantages of the Ocular therapeutics approach (OCUL), inserts that can dispense drugs with no preservative for a long time (e.g., 6 months).
There’s a huge market for Novavax - all the shareholders over on Twitter who swear they are waiting for it.
<<There is suggestion that heterologous boosting may be better…>>
I bought that argument or a variation thereof and took Pfizer as booster #2, had taken Moderna for my three prior vaccinations.