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Novavax, Inc. (NVAX)
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They are hiring someone to coordinate worldwide adjuvant supply/demand coordination. “We are seeking a Director/Associate Director, Production Planner responsible for leading the planning activities at our Adjuvant CDMOs and Sites This role will look in to balancing demand and supply volumes, inventory and asset capacity utilization to deliver a balanced and executable end-to-end plan in support of clinical, commercial and COVID19 global supply. Pro-active management of constraints mitigation and is responsible for the definition and design of the supply chain lead times and stock pockets. Responsible for evaluation of demand/supply scenarios, risk management implications and performance choices with associated costs including cost of goods sold reduction scenarios throughout lifecycle.”
If NVAX is considering Mabion as part of it’s pre-approval supply chain, this isn’t good. Let’s say they will add this node, as part of the post approval supply chain.
I saw a lot of bashing messages and a lot of pumping messages today. All should be disregarded. The bottom line is do not expect a rise after the Aug EC.
Note: Let Gail continue buying all the shares. Maybe she will acquire shares, so she can vote Stan out.
My eye is still on Sep, Oct and Nov for the ATH and above. Eye on the prize.
“Mabion ensures that the implementation of the framework agreement with Novavaks for the production of the COVID-19 vaccine component is progressing according to plan. The company from Lodz declares that it is about to complete advanced activities involving work on a small-scale process (in a laboratory) and is proceeding to prepare the production of a vaccine component on a commercial scale.”
“We are also in the process of carrying out the process on a commercial scale and the transfer of analytical methods to evaluate the product from a commercial scale. The preparation of the production line for commercial scale production, which is almost ready, is also at an advanced stage. Currently, we are supplementing the infrastructure with auxiliary devices, which, however, are not crucial for increasing the scale of the process. We expect delivery of these devices in August - says Dr. Sławomir Jaros.”
Mabion assures that the implementation of the framework agreement with Novavax, for the production of the vaccine component against COVID-19, is going according to plan. The Lodz-based company declares that it is completing advanced activities including work on the process on a small scale (in the laboratory) and is moving on to preparing the production of the vaccine component on a commercial scale.
- We are successfully finalizing the stage of work related to the small scale production process and implementation of a package of analytical methods sufficient for evaluation of the vaccine antigen on a laboratory scale, within which we have reproducibly obtained a high quality desired product. We performed this process on model bioreactors. They are of smaller capacity but at the same time representative for the process on the target scale, i.e. commercial scale (in bioreactors of larger capacity) - says Sławomir Jaros, PhD, member of the board and chief scientific officer of Mabion SA.
Jaros added that the company has prepared a quality system to start working on a commercial scale.
- We are also in the process of conducting a commercial scale process and transferring analytical methods to evaluate a commercial scale product. At an advanced stage is also the preparation of the production line for production on a commercial scale, which is almost ready.
We are currently supplementing the infrastructure with ancillary equipment, which, however, is not essential to scale up the process.
We expect to deliver these devices in August," says Sławomir Jaros, PhD.
Covid variants have changed several times as we all know. The vaccines to be effective must swiftly adjust as well. MRNA and PFE were designed to treat the original strain. Their efficacy and effectiveness wanes considerably in 6 months. They have no study data concerning booster shots effectiveness on the current virus strains raging out of control globally. They would like simple approval by the FDA to continue selling their product. It is not that simple, as we all know. NVAX has an inclusive, nimble, safe vaccine that is very soon to become the go to standard of excellence in the vaccine world. Production will most likely increase rapidly. The planned 2 Billion doses will will probably grow, and the booster shot will be in very high demand as well, adding the the increased dosage numbers. There will be a lot happening throughout August. Bank on it !!!
My $205 strike calls would have expired worthless today if I hadnt sold during the recent run-up to high 220s. Guys, till they file and get EUAs, unfortunately Nvax remains highly speculative and volatile stock. The frequent sudden drops from 220s proves it. If you have not diversified into other vaccine makers yet, BNTX is undoubtedly the best choice. Full FDA approval may happen as early as next month, China approval any time, not to mention blowout earnings, extremely undervalued compared to moderna, in comparison to whom they may actually have higher sales this year, unbelievable.
Today's IR of SK Bioscience cleared all uncertainties for Novavax. They said they will exceed the order target of 40m doses this year and are discussing with Novavax to export the surplus.
Congrats for all long investors !!!
keep in mind, as soon as EUA new comes, people will start jumping from MRNA/BNTX to NVAX to balance their positions as they know now MRNA/BNTX is over-valued in recent weeks and NVAX moved to the bottom. so EUA filing news will definitely explode NVAX price. main reason is less number of NVAX stocks and people know it is quality vaccine and only thing is missing is EUA filing and assurance of production capacity ( which NVAX team is working heads down without any PR)...
MRNA has a 1 yr target of $189 and its stock is trading at $330s
NVAX has a 1 yr target of $249.and its stock is trading at $187.
Soon investors will adjust the difference: SELL MRNA.
Novavax earning call in 6 Days, August is the month where approval can be announced any day which is starting next week. Do you think that they will announce approval prior earning report ?
Novavax might take into account some estimate changes and provide a straightforward rating system. Here are some nice articles about the psychedelic market that could make your day better.
Additionally, these other sectors could potentially provide with sample psilocybin supply for preclinical trials. Check the disclaimer on the landing page.
I was wondering if there are any data about how fast the Pfizer vaccine wanes. It turns out Pfizer itself showed that in the Briefing Document (Figure 4) presented to the FDA Advisory Committee on 12/20/2020. Neutralizing titer was 312 at day 29 (eight days after the second shot), then dropped to 161 at day 43 and 133 at day 50.
Extrapolating from that data, the neutralizing titer of Pfizer against the Wuhan virus would be below half of convalescent sera at about 5 months and near undetectable at about 7 months. This fast waning antibody protection is likely the reason behind the Israeli data showing many vaccinated people got infected with Delta, a far more virulent variant than the Wuhan virus. Note that despite data from the UK and Canada showing better vaccine efficacy, the Israeli data is likely more accurate. This is because Pfizer is used exclusively in Israel.
The neutralizing titer of NVAX at 3900 is more than ten times higher than Pfizer's. Further, overall antibody titer for NVAX is known to be still at the level of convalescent sera after 6 months. It can be deduced from that that NVAX is more durable and will be able to deal with variants better than Pfizer. Hopefully, we will hear more about variant data, especially on Delta, at the CC next week. Let's hope also that the consistency assays are done or nearly so. That's the gating factor for EUA/BLA approval.
So lately I’m noticing potential job opportunities are requiring to fill out Covid-19 “paperwork” before the interview process…
One of the questions is “are you vaccinated?”…
If so, bring ID vaccinations card.
well I’m not vaccinated yet!…
I Will not get mRNA pumped into my veins…
So now I’m loosing out on potential job opportunities.
I need this EUA paperwork submitted…
I know I’m not the only one in this predicament?
- Mr. Cat
NOVAVAX Letter to PREVENT-19 Trial Participants
July 20, 2021
To all participants in our PREVENT-19 clinical trial,
First, from everyone at Novavax, I want to extend our sincerest thanks for participating in our
NVX-CoV2373 clinical trial. Participation in clinical trials is a crucial part of medical research. We
appreciate your contribution to public health and your dedication to the advancement of a COVID-19
vaccine candidate, and firmly believe that clinical trial participants should not be disadvantaged with
respect to providing proof of vaccination.
We are glad that you were able to receive a vaccine earlier than most. We also empathize with
you as we recognize that proof of vaccination may be necessary to travel to certain destinations and for
engaging in some post-restriction activities. As a PREVENT-19 trial participant who received active
vaccine, you are now eligible to receive a modified vaccination card provided by the Centers for Disease
Control and Prevention (CDC). This card will serve as documentation of your participation in the study,
and that you have been vaccinated against COVID-19.
The modified vaccination cards are now being proactively distributed to trial participants by
ICON, our contract research organization, in coordination with the trial sites. The card states that you
have been vaccinated through a clinical trial and are to be considered fully vaccinated for public health
purposes. Should NVX-CoV2373 receive regulatory authorization, you may also receive the standard CDC
vaccination card if desired, and the vaccine can be recorded in the Immunization Information Systems
(IIS). Please reach out to your trial site if you do not receive this card or if you have questions.
The COVID-19 pandemic has been unprecedented and required vaccine development in record
time. While the vaccine development and manufacturing process is complex, we are working around the
clock to complete our regulatory filing as quickly as possible. Until then, NVX-CoV2373 continues to
demonstrate strong safety and efficacy in ongoing clinical trials.
Thank you again for your participation in the Novavax study.
Stanley C. Erck, CEO and President of Novavax
only about 200k shares have traded this last hour...anyone find this strange?
If you are new to this board I'll sum up a year and a half of posts. Some want Stan gone but on a positive announcement it's all high fives and we love Stan. There are lots of short bots bashing daily. Some of us just wait. The truth is we don't know how much longer it will be before we know anything.
What I do know as a Prevent 19 trial person. The Cov2373 shots are painless with no side effects. The New England Journal of Medicine. has listed our great results.
As an investor you can count on double the price per share in the near future. Could be one month maybe three months.
Once Nvax has approval the foundation will be solid and our investment will grow.
Richard Bergström (Sweden's vaccine coordinator) told DN (Swedish news agency) that the EU has an agreement underway, with Novavax. '' I know I've been saying that for six months now, but it's getting closer. It is a less experienced company in this context and therefore it has taken a long time ''
Breaking from India (tomorrow's news July 30) - India's desperate and just move up their target dose from 120 Million doses (July) to 150 Million doses (for August). Officials promised this big bump in supply. The previous day's news was to include Novavax in their August vaccine supply target, so I put the 2 news together. This could mean early August EUA in India, if they plan to jab Novavax in August. And remember - they're not getting Pfizer, JNJ, and no Moderna yet.
The science behind why Novavax's NVX-CoV2373 vaccine will not lead to waning immunity within weeks as is being observed for mRNA vaccines like Moderna's mRNA-1273 is clear from the findings in following studies. The study "SARS-CoV-2 spike glycoprotein vaccine candidate NVX-CoV2373 immunogenicity in baboons and protection in mice" (DOI: 10.1038/s41467-020-20653-8) published in Nature journal shows in Fig 8d that the neutralizing antibody titer levels generated by a single shot of the NVX-CoV2373 vaccine administered to baboons continue increasing after the shot and are at a high level at week 4 and continue to increase to higher levels beyond that as late as 35 days after administration when last measured. OTOH, the study "Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates" (DOI: 10.1056/NEJMoa2024671) published in NEJM shows in Fig 1b that the neutralizing antibody titer levels generated by mRNA-1273 vaccine administered in Rhesus Macaques start waning after 2 weeks of either dose administration and due to that the titer levels are not as high as observed for the NVX-CoV2373 vaccine after 4 weeks. So, once Novavax vaccine gets EUA approval and people start taking those shots we should see less breakthrough cases than currently being observed for mRNA vaccines and there would not be any need for boosters every few months, unlike the case now. The higher neutralizing antibody titer sustained levels generated by the NVX-CoV2373 vaccine should also allow less opportunities for the virus to mutate into new variants of concern.
The post below but in English per Google translate:
“ Today, Sk bio ir said that the Novavax material problem was difficult to solve.
40 million doses are currently in production”
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