Yet Gellin was the lone abstaining vote, saying the committee wasnt given data on how the vaccine performs against the Omicron variants now circulating, or for how many months its protection lasts. Covid-19 vaccine maker Novavax raised doubts Tuesday about its ability to continue its business, announcing plans to cut Select one or more newsletters to continue. Topline. Primary and secondary objectives of the study are to assess the safety, tolerability, and immune responses to various formulations of the CIC and influenza vaccine candidates. The Novavax vaccine also appears to carry a risk of heart inflammation for younger men, known as myocarditis and pericarditis, similar to Pfizer and Moderna's shots. of Early in their development, studies of those two vaccines included testing on a controversial cell line linked to an abortion in the 1970s that is widely used in medical research though neither shot ultimately uses any fetal tissue in manufacturing their vaccines. Novavax reported fourth-quarter losses of $182 million after only posting $357 million in saleswell below expectations of $383 million. Alastair Grant, Associated Press. June 3 (Reuters) - The U.S. Food and Drug Administration hasraised concerns about a possible risk of heart inflammation from Novavax Inc's (NVAX.O) FDA officials flagged four cases of myocarditis and pericarditis from Novavax's clinical trial in young men ages 16 to 28. Moderate The Centers for Disease Control and Prevention still needs to sign off on Novavax's vaccine before pharmacies and other health-care providers can start administering shots. FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. Sign up for free newsletters and get more CNBC delivered to your inbox. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. You may opt-out by. But 21 of the 22 advisers concluded any risk posed by heart inflammation was outweighed by the benefits of a vaccine that showed 90.4% efficacy against early strains of SARS-CoV-2 in a trial involving 30,000 people in the United States and Mexico. Novavax raised doubts about its future Tuesday as concerns grow about whether the Covid vaccine [+] maker will ever get a significant foothold in the United States. The accompanying condensed consolidated financial statements have been prepared assuming Novavax will continue as a going concern. Please enter valid email address to continue. Novavax's vaccine might also overcome some religious objections that have been lodged over how the Moderna and Pfizer-BioNTech shots were initially studied. CDC twenty four seven. We comply with the HONcode standard for trustworthy health information. The Food and Drug Administration o n Wednesday authorized a Covid-19 vaccine developed by Novavax, a biotechnology company in Maryland that However, the trial was conducted from December 2020 through September 2021, months before the omicron variant became dominant. We caution investors not to place considerable reliance on forward-looking statements contained in this press release. Amazon Pauses Construction on Second Headquarters in Virginia as It Cuts Jobs, iPhone Maker Plans $700 Million India Plant in Shift From China, S&P 500 Notches Best Week Since Late January: Markets Wrap, Amazon Is Closing Its Cashierless Stores in NYC, San Francisco and Seattle, Zoom Abruptly FiresPresident Greg Tomb Without Cause. Still, Gellin said, This vaccine has incredible potential. It is easy to store and transport, lasting at refrigerator temperatures for months, unlike the dominant messenger RNA (mRNA) vaccines. The effectiveness of Covid vaccines against mild illness has slipped substantially as the virus as evolved, though they still generally protect against severe disease. The first part seeks to enroll a total of approximately 1,500 participants in Australia and New Zealand. Generic name: SARS-CoV-2 vaccine "We're in the process of assessing the global footprint of Novavax, rationalizing our supply chain, rationalizing the portfolio and rationalizing the company structure and our infrastructure," Jacobs told Reuters. Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S. The COVID-19-Influenza Combination (CIC) Vaccine Candidate Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80. Reporting is encouraged for other clinically significant adverse events, even if it is not clear that a vaccine caused the adverse event. Saving Lives, Protecting People, National Center for Immunization and Respiratory Diseases, Use of COVID-19 Vaccines in the U.S.: Appendices, FAQs for the Interim Clinical Considerations, Myocarditis and Pericarditis Considerations, Jurisdictions: Vaccinating Older Adults and People with Disabilities, Vaccination Sites: Vaccinating Older Adults and People with Disabilities, Vaccinating Patients upon Discharge from Hospitals, Emergency Departments & Urgent Care Facilities, Vaccines for Children Program vs. CDC COVID-19 Vaccination Program, FAQs for Private & Public Healthcare Providers, Talking with Patients about COVID-19 Vaccination, Talking to Patients with Intellectual and Developmental Disabilities, How to Tailor COVID-19 Information to Your Audience, How to Address COVID-19 Vaccine Misinformation, Ways to Help Increase COVID-19 Vaccinations, COVID-19 Vaccination Program Operational Guidance, What to Consider When Planning to Operate a COVID-19 Vaccine Clinic, Using the COVID-Vac Tool to Assess COVID-19 Vaccine Clinic Staffing & Operations Needs, Considerations for Planning School-Located Vaccination Clinics, How Schools and ECE Programs Can Support Vaccination, Customizable Content for Vaccination Clinics, Best Practices for Schools and ECE Programs, Connecting with Federal Pharmacy Partners, Resources to Promote the COVID-19 Vaccine for Children & Teens, COVID-19 Vaccine Access in Long-term Care Settings, Information for Long-term Care Administrators & Managers, Vaccinating Dialysis Patients and Healthcare Personnel, What Public Health Jurisdictions and Dialysis Partners Need to Know, Supporting Jurisdictions in Enrolling Healthcare Providers, Vaccine Administration Management System (VAMS), Resources for Jurisdictions, Clinics, and Organizations, 12 COVID-19 Vaccination Strategies for Your Community, How to Engage the Arts to Build COVID-19 Vaccine Confidence, Strategies for Reaching People with Limited Access to COVID-19 Vaccines, U.S. Department of Health & Human Services. WebNovavax COVID-19 Vaccine, Adjuvanted is available under emergency use authorization (EUA) to prevent COVID-19 in individuals 12 years of age and older. This special highlights the best of the fifth annual event which was held in Singapore from November 14-17. The Department of Health and Human Services said Monday that it is still conducting quality testing of the Novavax vaccine. The shots consist of 5 micrograms of the spike copy and 50 micrograms of the adjuvant. Complete and submit reports to VAERS online. The mRNA vaccines that are already available work by providing cells with a blueprint to create spike proteins to trigger an immune response from the body. However, 27 million adults still have not gotten a single shot yet, according to CDC data from June. They help us to know which pages are the most and least popular and see how visitors move around the site. It is the fourth coronavirus vaccine It worked. The With nearly 22% of the nation yet to receive a single COVID-19 vaccine dose, federal vaccine advisers today recommended that the Novavax COVID-19 vaccine be approved under an emergency use authorization (EUA). You will be subject to the destination website's privacy policy when you follow the link. 13,14 Accordingly, development of effective and safe vaccines that provide Novavax presented data at an FDA committee meeting in late June demonstrating that a third dose of its vaccine produced a strong immune response against omicron and its subvariants. But manufacturing issues have hampered Novavaxs effort and sidelined its would-be U.S. vaccinemaking facilities. Some committee members raised eyebrows at the suggestion that the Novavax vaccine would win over a substantial number of the 27 million unvaccinated Americans with its familiar technology. We need to provide options to reduce excuses, Martha Dawson, president of the National Black Nurses Association, told the advisers. If authorized in the United States, the product will initially be manufactured, as all Novavax vaccine currently is, by the Serum Institute of India, one of the worlds largest vaccine manufacturers. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The company plans to ask the FDA to authorize a third dose of its vaccine. These cookies may also be used for advertising purposes by these third parties. ET. Waning interest in Covid-19 vaccines has left a long-standing drug developer, Novavax Inc., struggling to stay afloat and handed short sellers The first data on those shots are expected "in the late summer or fall," the company says. Novavaxs Covid-19 vaccine was the first product the 36-year-old company brought to the market. "Today's authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA's rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," said FDA Commissioner Dr. Robert Califf in a release on Wednesday. But in response to a query from Doran Fink, acting deputy director of FDAs vaccine approval branch, Nelson said the agency should include a warning about heart risks in the package insert. Novavax was one of the original participants in the U.S. government's race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. The vaccine company Novavax, which manufactures COVID-19 vaccines, says it has substantial doubts about its own ability to stay in business long term. To maximize our opportunities and mitigate the significant risks and uncertainties of the COVID-19 market, our goal is to reduce spend, extend our cash runway and operate efficiently to best position the company to deliver long-term growth. It was the generation of the assays to illustrate that we could make the product over and over again, the same way, and to deploy those assays against the multiple lots," said Novavax's Filip Dubovsky. Novavax COVID-19 Vaccine (SARS-CoV-2 vaccine) Consumer information. ET on February 28, 2023 until 11:59 p.m. A replay of the webcast will be available on the Novavax website until May 28, 2023. These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines, FDA wrote. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Find information and resources for each of the available Novavax COVID-19 Vaccines. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. In 2023, Novavax intends to focus the organization to align our investments and activities with our top priority of delivering an updated Covid-19 vaccine consistent with public health recommendations for strain composition for the 2023 fall vaccination season. They help us to know which pages are the most and least popular and see how visitors move around the site. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Follow the COVID-19 vaccination schedule (below) based on age and medical condition. Approved vaccines for shingles, hepatitis B, and influenza use similar protein-based technology. Certainly the benefits outweigh the risks, said adviser Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine. The Phase 2 dose-confirmation trial will be conducted in two parts. In July 2022, the FDA authorized the Novavax COVID-19 vaccine for adults. Primary series:Two-dose primary series given three weeks apart, for individuals 16 years and older. Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS (COVID-19) Nanoparticle Vaccine With/Without Matrix-M Adjuvant, Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster, U.S. Centers for Disease Control and Prevention Recommends Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults, U.S. Centers for Disease Control and Prevention Expands Recommendation for Novavax COVID-19 Vaccine, Adjuvanted to Adolescents Aged 12 Through 17, U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Adolescents Aged 12 Through 17, Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older, Novavax Announces Initiation of Phase 2b/3 Hummingbird Global Clinical Trial for the Novavax COVID-19 Vaccine in Children Aged Six Months Through 11 Years, U.S. FDA Grants Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted for Individuals Aged 18 and Over, FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older, Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial, Health Canada Authorizes Novavax COVID-19 Vaccine, Novavax Announces Positive Results of COVID-19 Vaccine in Pediatric Population of PREVENT-19 Phase 3 Clinical Trial, New Zealand's Medsafe Grants Provisional Approval for Novavax' COVID-19 Vaccine, Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine, Novavax Submits Final Data Packages to U.S. FDA as Prerequisite to Emergency Use Authorization Application Request for COVID-19 Vaccine, Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies, Novavax Announces Initiation of PREVENT-19 COVID-19 Vaccine Phase 3 Trial Booster Study, World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine, Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine, Novavax Statement on PREVENT-19 Phase 3 Clinical Trial Results Publication in the New England Journal of Medicine, Novavax Statement on Omicron Variant Response, Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization, Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization, Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand, Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia, Novavax Files for COVID-19 Vaccine Authorization with Health Canada and Completes Submission for Rolling Review to European Medicines Agency, Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia, Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom. Im very skeptical that vaccine-hesitant people will elect to get this vaccine, said committee member Jay Portnoy, an allergist and immunologist at Childrens Mercy Hospital. WebNovavax COVID-19 vaccine (recombinant, adjuvanted) is now conditionally authorized in several regions. An additional Phase 3 pivotal clinical trial conducted in the United States and Mexico commenced December 2020 and included 30,000 participants with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age, and those living with co-morbidities. Cookies used to make website functionality more relevant to you. Novavax has otherwise touted its use of older vaccine We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine, Denny Kim, Novavaxs chief safety officer, told the FDA advisers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. ET on March 7, 2023. The committee recommended authorization for the two-shot series in adults 18 years and older. Novavax is not responsible for the privacy policy of any third-party websites. CDC twenty four seven. Their hesitancy is more ideological than technological., But a parade of public speakers at the meeting mostly urged the committee to authorize the vaccine. Novavax has otherwise touted its use of older vaccine technology for its COVID shot as a good alternative to the country's stable of effective vaccines because it has been administered with fewer side effects during trials than the Pfizer or Moderna shots. A key committee of advisers to the U.S. Food and Drug Administration (FDA) today recommended nearly unanimously that the agency grant an emergency authorization to a COVID-19 vaccine from Novavax, opening the way for the first protein-based COVID-19 vaccine to become available to people in the United States. This type of heart inflammation side effect has also been noted by the CDC as a "rare risk" associated with the mRNA vaccines from Pfizer-BioNTech and Moderna, according to multiple studies. Half the participants received two intramuscular injections of vaccine comprising 5 g of protein antigen with 50 g MatrixM adjuvant, administered 21 days apart, and half of the trial participants received placebo (saline). This kind of technique, called protein subunit vaccines, has long been used widely in other shots. Alex Murdaugh sentenced to life in prison for murders of wife and son, Biden had cancerous skin lesion removed last month, doctor says, White supremacist and Holocaust denier Nick Fuentes kicked out of CPAC, Tom Sizemore, actor known for "Saving Private Ryan" and "Heat," dies at 61, Biden team readies new advisory panel ahead of expected reelection bid, At least 10 dead after winter storm slams South, Midwest, House Democrats unhappy with White House handling of D.C.'s new criminal code. Myocarditis concerns may also dog the vaccine. Alastair Grant, Associated Press. Coronavirus Disease 2019 (COVID-19), Recalls, Market Withdrawals and Safety Alerts, COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders, Fact Sheet for Healthcare Providers Administering Vaccine, HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO, FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA, T THNG TIN CHO NGI NHN V NHNG NGI CHM SC. 2 It is the first protein-based COVID-19 vaccine authorized in the U.S. zoranm / Getty Images. With Novavax, each vaccine is spaced three weeks apart. Your tax-deductible contribution plays a critical role in sustaining this effort. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Brand name: Novavax COVID-19 Vaccine The US Food and Drug Administration on Wednesday authorized Novavaxs Covid-19 vaccine for emergency use in adults. Dr. Peter Marks, a senior FDA official, said Novavax's vaccine would potentially appeal to unvaccinated people who would prefer a shot that is not based on the messenger RNA technology used by Pfizer and Moderna. However, Novavax has argued that "there continues to be a role" for the current version of its vaccine. Before sharing sensitive information, make sure you're on a federal government site. WebAmpoules containing the COVID-19 vaccine Nuvaxovid from the manufacturer Novavax sit on a table at a vaccination center on April 1, 2022, in Quedlinburg, Germany. Treatment for: COVID-19. The dial-in numbers for the conference call are (833) 974-2381 (Domestic) or (412) 317-5774 (International). The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2 to 8C, enabling the use of existing vaccine supply and cold chain channels. John Deere boasted record profits in 2021 and finally struck a deal with striking union workers. Available for Android and iOS devices. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS, (in thousands, except per share information). The law governing emergency use authorizations (EUAs) by FDA requires that there is no adequate, approved and available alternative to a product. Major: Highly clinically significant. The fact sheets authorized for Novavax's shots will ultimately include the warning, the FDA said. Pfizer and Moderna's vaccines use mRNA, a molecule encoded with genetic instructions, to tell human cells to produce copies of a virus particle called the spike protein. For further assistance with reporting to VAERS, call 1-800-822-7967. One advisory committee member asked Peter Marks, FDAs top vaccine official, why the Novavax vaccine meets that requirement given that three other vaccines are already available to people in the United States. Anything we can do to get people to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do.. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The FDA also said last month it was at loggerheads with Novavax over whether to attach a warning of myocarditis potentially linked to the shots. CBS News reporter covering public health and the pandemic. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. The FDA's decision comes more than a month after the vaccine earned the near unanimous backing of the regulator's own panel of outside advisers. Data is a real-time snapshot *Data is delayed at least 15 minutes. Given these uncertainties, substantial doubt exists regarding our ability to continue as a going concern through one year from the date that these financial statements are issued. WebThese classifications are only a guideline. Global Business and Financial News, Stock Quotes, and Market Data and Analysis. The study evaluated two doses (administered 21 days apart) of NVXCoV2373 across two dose levels (5 g and 25 g), with and without the MatrixM adjuvant. Its also the most profitable short among biotechs since the stock hit a peak at the height of the outbreak, according to Matthew Unterman, a director with S3. Clinical trial data shows the shot to be highly effective with fewer side effects than other vaccines available in the U.S. Novavax uses a protein-based technology, a more traditional approach than the novel technologies used by other vaccine manufacturers. FDA authorization of Novavax's vaccine was delayed for weeks as the agency reviewed changes to the company's manufacturing process. July 13, 2022. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1137418. However, the vaccine will likely have lower effectiveness against omicron as is the case with Pfizer and Moderna's shots. If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease Novavaxs vaccine, which is produced in insect cells and combined with an immune-boosting substance called an adjuvant, has already been authorized in more than 40 countries including the United Kingdom, Canada, Germany, and Australia; it has also won emergency authorizations from the European Union and the World Health Organization. Science and AAAS are working tirelessly to provide credible, evidence-based information on the latest scientific research and policy, with extensive free coverage of the pandemic. It found a new life as it collected $2 billion to develop a vaccine, first from an international organization that supports vaccinemaking and then from the U.S. government. Please make a tax-deductible gift today. Credit: Unsplash/CC0 Public Domain. The Novavax shot is based on more conventional protein technology used for decades in hepatitis B and HPV vaccines, while Pfizer and Moderna are the first FDA approved vaccines to use mRNA. We take your privacy seriously. The thumbs up from the FDA advisers likely means the agency will allow the company to enter the U.S. market, as FDA usually follows its advisers lead. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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Centers for Disease Control and Prevention. A first booster dose to the following individuals at least 6 months after completion of primary vaccination with an authorized or approved COVID-19 vaccine: Individuals 18 years of age and older for whom an FDA-authorized mRNA bivalent COVID-19 booster vaccine is not accessible or clinically appropriate. Novavax was one of the original participants in the U.S. government's race to develop a Covid vaccine in 2020, receiving $1.8 billion in taxpayer funding from Operation Warp Speed. Like the other available COVID-19 vaccines, Novavax's shots will need to be formally recommended by the Centers for Disease Control and Prevention before they can be made available. Three cases were in men ages 16 to 20. 10+ years. WebThese classifications are only a guideline. Copyright 2023 CBS Interactive Inc. All rights reserved. When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. Prepare and administer the appropriate product based on the recipients age. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Novavax is committed to accelerating the development of new and promising vaccines by building on years of study and experience. 2022 CBS Interactive Inc. All Rights Reserved. Insight and analysis of top stories from our award winning magazine "Bloomberg Businessweek". Johnson & Johnson's Janssen vaccine uses a cell line that was originally developed from an abortion. If it wins final authorization, the vaccine will be the fourth COVID-19 jab marketed in the United States. The Novavax vaccine also uses an additional ingredient called an adjuvant, which is extracted and purified from the bark of a tree in South America, to induce a broader immune response. Some 3.2 million doses of Novavax's vaccine have been secured by the Biden administration. While our current cash flow forecast for the one-year going concern look forward period estimates that we have sufficient capital available to fund operations, this forecast is subject to significant uncertainty, including as it relates to 2023 revenue, funding from the U.S. government, and pending arbitration.