Given so many Americans have yet to receive their boosters despite the clear indication of their impact on reducing risk of severe complication from COVID-19, that improvement in vaccine uptake may be somewhat limited," said John Brownstein, Ph.D., an epidemiologist at Boston Children's Hospital and an ABC News contributor. "Having vaccine options likely plays role in improving vaccination coverage. But the vaccine which relies on a protein-based technology used for decades may appeal to the sliver of the population allergic to components of the messenger RNA vaccines developed by Pfizer-BioNTech and Moderna, or who are skeptical of those shots newer technology. The biggest issue with Novavax, Inc. stock for years now is that promising vaccine developments only lead to the biotech selling more shares. Wanneer u onze sites en apps gebruikt, gebruiken we, gebruikers authenticeren, veiligheidsmaatregelen toepassen en spam en misbruik voorkomen, en, gepersonaliseerde advertenties en content weergeven op basis van interesseprofielen, de effectiviteit meten van gepersonaliseerde advertenties en content, en, onze producten en services ontwikkelen en verbeteren. . Maryland-based Novavax is hoping to gain a foothold within the roughly 27 million U.S. adults who are yet to be vaccinated, particularly those who do not want to receive a vaccine like the Pfizer (PFE.N)/BioNTech (22UAy.DE) or Moderna Inc (MRNA.O) shots based on groundbreaking messenger RNA (mRNA) technology. The vaccine was 100% effective at preventing moderate or severe . Investing includes risks, including loss of principal. Berkeley Lovelace Jr. is a health and medical reporter for NBC News. On Dec. 31, Novavax announced that it submitted its final data package to the U.S. Food and Drug Administration and said it expects to file its application for emergency use approval by the end of . Stone Fox Capital Advisors, LLC is a registered investment advisor founded in 2010. Novavax, Inc. Feb 28, 2023, 16:02 ET. The amazing part about this statement is that Novavax ended 2022 with a cash balance of $1.3 billion. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. Sure, the FDA needs time to review all the data and information that Novavax submitted as part of the EUA application to feel confident about the safety and effectiveness of Nuvaxovid being used as a booster. He previously covered the biotech and pharmaceutical industry with CNBC. The CDC recommends an mRNA vaccine over the J&J vaccine. Novavax has submitted an application to the Food and Drug Administration for Emergency Use Authorization of its COVID-19 vaccine as a booster in adults that can be used on top of its primary . The biotech doesn't make any case in why patients will prefer the Nuvaxovid vaccine over ones from Pfizer and Moderna already well established in the developed markets. "Some people are suspicious" of the mRNA vaccines, which use a new technology, said Dr. Ofer Levy, the director of the Precision Vaccines Program at Boston Childrens Hospital. . But the company, which had never produced a successful vaccine before, ran into a series of production issues and struggled for months to meet U.S. regulatory standards, falling well behind the pace set by competitors. This could help vaccination efforts better reach those who may be currently harder-to-reach, such as low income or rural locations that may not have the freezers needed to store the Covid-19 mRNA vaccines. As part of this authorization, it is mandatory for the company, Novavax Inc., and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS): serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death. Novavax is the Newest COVID-19 Vaccine. The Novavax primary series is given in two doses, administered 21 days apart. This protein subunit vaccine delivers purified copies of the spike protein of SARS-CoV-2, the coronavirus that causes COVID-19. "Anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do," he added. Because the Novavax vaccine is coming onto the scene late in the pandemic with the majority of vaccinated Americans receiving an mRNA vaccine its not clear what role this vaccine will play in the countrys COVID-19 response going forward. Probiotic supplements can be used as one part of an immune-boosting protocol to help reduce the likelihood of coronavirus infection. Nearly fifteen months after the first coronavirus vaccine gained emergency use authorization by the US FDA (and 555 million jabs in American arms later), Maryland-based Novavax is one step closer . For those following Novavax, the company spent decades trying to get various vaccines approved by the FDA, and the very undoing of the company could be the approval of the covid vaccine. In late-stage clinical trials with more than 25,000 participants spanning the U.S. and Mexico, the vaccine was more than 90 percent effective at preventing Covid-19 infections and 100 percent effective at preventing hospitalizations. Novavax COVID-19 Vaccine, Adjuvanted contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Structural changes in the brain may explain the persistent fatigue and neuropsychiatric complications tied to long COVID. Biotech company Novavax has revealed its COVID-19 vaccine can generate effective . The .gov means its official.Federal government websites often end in .gov or .mil. The FDA declined to comment, and the people with knowledge of the matter cautioned the plan could still change. In clinical trials, the Novavax vaccine was found to be 90% effective at preventing mild, moderate and severe COVID-19. If successful, Novavax would have . Novavax, Inc. provided the following somewhat shocking statement to investors with the Q4 2022 earnings release: The company suggests having sufficient capital to fund operations for the next year, but the uncertainty around the covid vaccine and the Gavi lawsuit raises questions regarding a going concern. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. T he ever-evolving landscape of Covid-19 vaccines shifted again on Monday, with Moderna winning full approval for its jab from the Food and Drug Administration, and Novavax submitting a long . Novavax is the fourth COVID-19 vaccine to either get authorized or fully approved. Across the country, 110 million Americans or more than half of those eligible to be boosted have yet to receive their first booster shot, according to data from the CDC. Its not as if the Nuvaxovid vaccine is completely new, despite its name starting with a new sound. However, the studies need to be done to actually determine whether that is a good idea, said Cohen. The Biden administration secured 3.2 million doses of Novavax's COVID-19 vaccine. See here for a complete list of exchanges and delays. The EUA was issued to Novavax Inc. The Barenaked Ladies may have sung, It's been one week since you looked at me. But its been eight weeks since Novavax announced that they had submitted a emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA). As a prime example, the company recently raised ~$250 million via a concurrent convertible debt offering and a public offering of 8.5 million shares at just $10 per shares. The FDA authorization took "longer than we wanted," Novavax CEO Stanley Erck told NBC News in an interview, "but we're there and we have gotten the company's first approval with the FDA for a vaccine in the United States.". In the subset of participants 65 years of age and older, the vaccine was 78.6% effective. As vaccination rates stall nationwide, an additional vaccine like Novavax may seem unnecessary. By Its been available in the U.S. as a two-dose primary series for adults (meaning for adults who havent received any Covid-19 vaccines yet) since mid-July after receiving an EUA on July 13 from the FDA. June 14, 2021. I wrote this article myself, and it expresses my own opinions. Wij, Yahoo, maken deel uit van de Yahoo-merkenfamilie. A CDC panel may consider the Novavax shots late next week. 13,14 Accordingly, development of effective and safe vaccines that provide broad immunization against susceptible strains . "We do have a problem with vaccine uptake that is very serious in the United States," FDA official Peter Marks told the panel. The agency has since cleared Covid vaccines for everyone six months and up, as well as several rounds of booster shots, and granted full approval to Pfizers vaccine for children as young as 12. Patients have generally fewer adverse reactions like pain at the injection site, fever, headache, etc. See here for a complete list of exchanges and delays. At today's meeting, Filip Dubovsky, MD, MPH, Novavax's senior vice president and chief executive officer, said the company expects in the coming months to seek clearances for expanded age indications and use as a booster dose. This generates a protective immune response without causing illness. The vaccines were rigorously tested to assess their safety and. Novavax, a biotech company headquartered in Maryland, still needs to complete a final round of quality testing for its vaccine over the next several days. Novavax and Sanofi are a year behind other drugmakers in delivering a Covid-19 vaccine. Before sharing sensitive information, make sure you're on a federal government site. The Department of Defense and the Department of Health and Human Services secured 3.2 million doses of Novavax in June in advance of the decisions by the FDA and CDC. [1/2]Vials labelled "VACCINE Coronavirus COVID-19" and a syringe are seen in front of a displayed Novavax logo in this illustration taken December 11, 2021. One potential safety concern raised during the FDA meeting is myocarditis inflammation of the heart muscle. The Food and Drug Administration is expected to authorize Novavaxs coronavirus vaccine for emergency use as early as Wednesday, two people with knowledge of the matter told POLITICO. Als u niet wilt dat wij en onze partners cookies en persoonsgegevens voor deze aanvullende doeleinden gebruiken, klik dan op 'Alles weigeren'. Of course, with the Pfizer-BioNTech and Moderna Covid-19 mRNA vaccines having been the Alpha-dog vaccines (and Beta-dog, Delta-dog, etc. The authorization will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. Our website services, content, and products are for informational purposes only. The effectiveness of the vaccine was assessed in clinical trial participants 18 years of age and older who did not have evidence of SARS-CoV-2 infection through 6 days after receiving the second vaccine dose. After a study from Australian scientists determined the effectiveness of the Novavax vaccine underperformed against the mRNA-based vaccines from these larger biotechs, the company faces an even bigger uphill battle in 2023. In contrast to the mRNA vaccines, which are based on a newer vaccine technology, Novavaxs product uses a more traditional technology. Healthline Media does not provide medical advice, diagnosis, or treatment. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. I wrote this article myself, and it expresses my own opinions. With the Covid emergency I suspended my practice of . Many also agreed that the efficacy profile looked similar to earlier approved mRNA vaccines, and some noted the benefits of a different vaccine that has easier storage requirements and less reactogenicity for those who are sensitive to mRNA vaccine side effects. | Carsten Koall/Getty Images, By Adam Cancryn and Katherine Ellen Foley. Though COVID vaccines may utilize different delivery mechanisms, the end result is the same: cells in the body recognize that a spike protein (the spikes you see sticking out of the coronavirus in pictures) doesn't belong, and the immune system reacts by activating immune cells and producing antibodies to attack the real virus if you get exposed. Continued manufacturing problems led to a delay in winning regulatory approval, and by the . Hannah Beier/Bloomberg via Getty Images, FILE. Als u uw keuzes wilt aanpassen, klik dan op 'Privacyinstellingen beheren'. However, that demand has not materialized in Europe, where Novavax also said it could drive up vaccination among the hesitant. The spike proteins are produced by a recombinant technology thats long been used by other vaccines such as Hepatitis B and pertussis vaccines, as I covered for Forbes back in mid-July. The Food and Drug Administration on Wednesday authorized Novavax's protein-based Covid vaccine for adults, providing Americans with an . Besides, if the company couldn't produce a profit during the covid period, Novavax, Inc. investors should have grave concerns about how the business can accomplish this goal when the disease is in the endemic phase. Although half a million doses of Novavax's vaccine have now been distributed to states, following its authorization last month, just 9,700 doses of Novavax's COVID-19 vaccine have been administered across the country, according to federal data. The American public can trust that this vaccine, like all vaccines that are used in the United States, has undergone the FDAs rigorous and comprehensive scientific and regulatory review., FDA Evaluation of Available Effectiveness Data. The company forecasts a $15+ billion annual market for covid vaccines, with the U.S. and the EU accounting for $10 billion per year. Prior to covid, Novavax had done a 1-for-20 reverse split to reduce the share count. The Trump administration in 2020 went as far as pre-ordering 110 million doses of the vaccine, investing $1.6 billion in the process. Novavax plans to lower the opex spend to $370 million per quarter, but the company will still spend at an annual clip of $1.5 billion now. Novavax stock is one to avoid, even after crashing below $7 on the dire warning. This is not the first time Novavax has struggled to move its vaccine forward. Stocks in focus: Reata Pharmaceuticals stock soars after FDA-drug approval; Novavax falls after vaccine maker issues 'substantial doubts' over future operations Published: March 1, 2023 at 7: . After a comprehensive analysis and evaluation of the data, and assessment of the manufacturing processes and information, as well as input from the FDAs committee of external independent advisors, the FDAs medical and scientific experts have determined that the vaccine meets the FDAs high standards for safety and effectiveness for emergency use authorization, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. But he said there are still questions about cross-protection in Omicron settings and expressed confidence that FDA staff will evaluate more data than VRBPAC saw before making its final recommendation. In other US developments, the CDC today said the BA.4 and BA.5 Omicron subvariants are starting to become more prevalent across the country, and a new survey of US public schools found that rural and lower income schools were less likely than others to make ventilation improvements to reduce the spread of COVID-19. About Nuvaxovid (NVX-CoV2373) Novavax's COVID-19 vaccine is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. Two months later, there is still no sign of a decision from regulators. By the Numbers: COVID-19 Vaccines and Omicron. All rights reserved. The FDA did not provide a timeline for when it would complete its review of the vaccine. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Food and Drug Administration. REUTERS/Dado Ruvic. Is this happening to you frequently? The U.S. Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DOD), today announced that it has secured 3.2 million doses of Novavax's COVID-19 vaccine. Mark has his Series 65 and is also a CPA. Ampoules of the Nuvaxovid vaccine against Covid-19 by Novavax are prepared for use. During today's meeting, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was asked to weigh the benefits and risks in people ages 18 and older. The unexpected data was delivered to a panel convened by the FDA to recommend booster plans for later this year. They made up about 70% of all new Covid cases in the U.S. for the week ending July 2, according to the CDC. These offerings were completed at the end of 2022 prior to issuing this going concern statement. April 29, 2021 -- Novavax's COVID-19 vaccine may be the next shot to receive emergency authorization in the U.S.. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning that clinical trial data provide evidence for increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following administration of Novavax COVID-19 Vaccine, Adjuvanted. The FDA is looking at safety data and following up with patients who were vaccinated . T he Food and Drug Administration announced Wednesday that it has authorized a booster shot for Novavax's Covid-19 vaccine. New COVID-19 boosters could be authorized by the FDA before full data from human trials are in because of past data on similar vaccines. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Novavax vaccine is already approved for emergency use in other countries, and US officials hope that a vaccine made with a more traditional process might sway some who have been hesitant to be immunized against COVID-19. The Novavax COVID-19 Vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). Novavax, up for FDA authorization, will be a good booster option. The Nuvaxovid vaccine would serve as a great response to those anonymous anti-vaccination social media accounts that have kept trying to convince people not to get the Covid-19 mRNA vaccines by claiming incorrectly that such vaccines are actually gene therapy and somehow alter your DNA. Regarding our full year 2023 revenue, our performance will depend on our ability to deliver an updated version of our COVID-19 vaccine for the 2023 fall vaccination season. Though, investors did have nearly a year to unload shares above $200 in another prime sign of how taking advantage of market opportunities is a must versus stubbornly holding a stock for the long term. As a result of the manufacturing changes, the agency may take longer to authorize Novavaxs vaccine than it did with the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines, all of which received approval shortly after getting the thumbs up from the advisory committee. The . In other words, many could end up being rather bare naked should Covid-19 surge again soon. Before shots can be administered, the FDA must authorize the vaccine and the Centers for Disease Control and Prevention (CDC) needs to green light its use. It is also mandatory for vaccination providers to report all vaccine administration errors to VAERS for which they become aware and for Novavax Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA. If the Food and Drug Administration (FDA) accepts the group's recommendation and Centers for Disease Control and Prevention (CDC . 24/7 coverage of breaking news and live events. Around 12.6 million doses of the vaccine have been distributed in the European Union, but only around 220,000 doses of the two-shot inoculation have been administered there since it was launched in December. The FDA normally follows the committees recommendation, but it is under no obligation to do so. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated . In using an old standby technology, Nuvaxovid vaccines dont have to be kept as cold as the Covid-19 mRNA vaccines need to be kept, making Nuvaxovid vaccines a whole lot easier to transport and store. Clinical Trial, Coronavirus COVID-19, covid-19, Covid-19 Vaccines, Full Approval, Novavax, Novavax Vaccine . The U.S. has secured 3.2 million doses of the vaccine, ready to be shipped to states once it receives the green light, the Biden administration announced Monday. The vaccine also contains an adjuvant, which helps stimulate the immune response. Americans have been ditching Covid-19 precautions such as face mask wearing as if they were furry boots, shutter shades, or neon activewear. 07/12/2022 12:55 PM EDT. Pfizer Says Bivalent COVID-19 Booster Significantly Increases Antibodies to Fight Omicron. important to the nations vaccination campaign, published in The New England Journal of Medicine in December. . This vaccine also doesnt have PEG [polyethylene glycol], which is a chemical [used as a stabilizer] in the mRNA vaccines, and something people can be allergic to, he added. Having an additional booster to choose from could really help the U.S. population in general. In June, the FDAs external advisory committee of experts voted 21-to-0 with one abstention to recommend the agency authorize the Novavax vaccine. U kunt uw keuzes te allen tijde wijzigen door te klikken op de links 'Privacydashboard' op onze sites en in onze apps. Itchy Throat: Could It Be COVID-19 or Something Else? An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted, Emergency Use Authorization for Vaccines Explained, Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry, Development and Licensure of Vaccines to Prevent COVID-19; Guidance for Industry. Can Probiotics Help Prevent or Treat COVID-19 Infection? "We hopefully expect to have product in the U.S. in our warehouse by the end of June," he said in an interview, adding that the company plans to ship millions of doses made by its partner, the Serum Institute of India, soon after authorization. A nurse draws the Novavax vaccine into a syringe at the vaccination center in Freising, Germany. "There could be some people who were on the fence with the mRNA vaccines who would be willing to take this one," he said. I am hopeful that this [vaccine] will convince people hesitant to mRNA vaccination [to get vaccinated], for whatever reason they are hesitant, said Frieman. Wij, Yahoo, maken deel uit van de Yahoo-merkenfamilie. This is great for people who are concerned about reactions to the mRNA vaccines.. Tunisia's powerful UGTT labour union rallied in the capital on Saturday, mobilising thousands of supporters against President Kais Saied in a demonstration of its strength after his recent crackdown on opponents. (Photo by Patrick van Katwijk/Getty Images), Novavax announced that they had submitted a emergency use authorization (EUA) application, having received authorization for use in the European Union back in December 2021, the Japan Ministry of Health, Labour and Welfare (MHLW) had granted approval, a research letter recently published in the, only 4.4 million Americans have gotten the bivalent Covid19 mRNA boosters. Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. Last week, the two subvariants were under the threshold of 1% and weren't listed separately. The biotech is competing with much larger biotechs in Pfizer (PFE), BioNTech SE (BNTX), and Moderna (MRNA), reducing the ability to effectively compete on covid vaccines when the company is seen as a distant third option, at best. The Novavax vaccine is a recombinant nanoparticle protein-based product that contains an adjuvant. Novavaxs vaccine uses an older technology found in other widely used vaccines, including the shots for hepatitis and shingles. But the Biden administration earlier this week purchased 3.2 million doses of the vaccine in anticipation of the shot soon receiving a green light from the agency. Clinical trial results, published in The New England Journal of Medicine in December, found two doses of Novavaxs vaccine were about 90% effective. Dive Brief: Shares of Reata Pharmaceuticals nearly tripled in value Wednesday after the company won Food and Drug Administration approval to sell the first treatment for a rare neuromuscular disease called Friedreich's ataxia. The company ended 2022 with over 78 million diluted shares outstanding. Adverse events that occur in a recipient after COVID-19 vaccination are required to be reported to the Vaccine Adverse Event Reporting System (VAERS). 2005-2023 Healthline Media a Red Ventures Company. Credit: Unsplash/CC0 Public Domain. Receiving any of the COVID-19 vaccines is better than remaining unvaccinated. The Food and Drug Administration on Wednesday authorized Novavaxs protein-based Covid vaccine for adults, providing Americans with an alternative to the mRNA-based shots from Pfizer-BioNTech and Moderna. Our Standards: The Thomson Reuters Trust Principles. Thus, should Nuvaxovid be authorized as a booster, it would be probably be most useful as heterologous booster. The clinical trial was conducted prior to the emergence of delta and omicron variants. It's finally here: After a series of delays in the lead-up to Novavax's COVID-19 vaccine filing with the FDA, the biotech has completed its emergency use authorization request. The CDCs Advisory Committee on Immunization Practices is scheduled to meet on July 19. The decision comes as White House officials stress the importance of vaccination to prevent severe disease. As a condition of authorization, the company will conduct studies to further assess its safety, including studies to further assess the risks of myocarditis and pericarditis. Two new observational studies suggest that COVID-19 vaccination lowers long-COVID incidence and severity. The Food and Drug Administration has authorized Novavax 's two-dose vaccine for adults ages 18 and over, the fourth Covid shot to get emergency approval in the U.S. since the pandemic began. Novavax reported that a part II of its phase III study on the COVID-19 Omicron BA.1 vaccine candidate will evaluate the candidate vaccine compared with an Omicron BA.5 vaccine, as well as a . Lees ons privacybeleid en cookiebeleid voor meer informatie over hoe we uw persoonsgegevens gebruiken. "Todays authorization offers adults in the United States who have not yet received a Covid-19 vaccine another option that meets the FDAs rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization," FDA Commissioner Dr. Robert Califf said in a statement. This was an application for their protein-based Covid-19 vaccine Nuvaxovid (NVX-CoV2373) to be used as a booster, meaning a follow-up vaccine dose after someone has already received the primary series of Covid-19 shots. After an all-day meeting on June 7, the FDAs independent panel of vaccine experts voted 20 to 0, with one abstention, to recommend that the vaccine receive an emergency use authorization (EUA). Early indicators suggest that the authorization has yet to convince a large swath of the 26 million unvaccinated American adults to get the shot. While this vaccine has been slow to get out of the gate, supporters say this more traditional vaccine still has a role to play in the countrys ongoing fight against coronavirus. And some on social media have questioned why its taking so long for the FDA to consider the EUA amendment application to be A-OK. For example, health journalist and science writer Liz Highleyman wondered aloud on Twitter (as opposed to wondered silently on Twitter) why the Novavax vaccine isnt already available as a booster in the U.S.: As you can see, Highleyman posted this query after Eric Topol, MD, founder and director of the Scripps Research Translational Institute, had tweeted about a study that showed how the Novavax vaccine was able to induce robust T-cell immunity, which by the way is a good thing. Meanwhile, the protection offered by peoples primary series vaccinations or previous infections from 2021 may have waned significantly by now. The Covid-19 mRNA vaccines consist primarily of messenger RNA (mRNA) that serve as blueprints for your cells to manufacture spike proteins. Reason Roundup. In making this determination, the FDA can assure the public and medical community that a thorough analysis and evaluation of the available safety and effectiveness data and manufacturing information have been conducted. The company is preparing to file the FDA paperwork in coming weeks and could .
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