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FDA's Regulatory Delay Is The Reason For Novavax, Lucira Health's Failure: WSJ Report
FDA's Regulatory Delay Is The Reason For Novavax, Lucira Health's Failure: WSJ Report
Failures of Covid vaccine maker Novavax Inc (NASDAQ:NVAX) and diagnostic start-up Lucira Health Inc (NASDAQ:LHDX) show that companies often succeed or fail, owing to the whims of the government.
Last week, while reporting Q4 earnings, Novavax raised doubts about its ability to remain in business and announced plans to cut spending.
The Covid-19 vaccine was Novavax's first and only commercial product in its 36-year history, Wall Street Journal writes. However, the product flopped after successful trials thanks to regulatory delays and manufacturing hiccups.
Operation Warp Speed awarded Novavax $1.6 billion to cover testing and manufacturing costs of its experimental vaccine in exchange for 100 million doses if the FDA authorized it.
Novavax's struggled to scale manufacturing, which delayed the start of its late-stage U.S. trial to December 2020.
By then, the FDA had authorized COVID-19 vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE). Yet there was still expected to be enormous demand for its vaccine in low-income countries and among Americans hesitant to get mRNA shots.
Novavax announced in June 2021 that its vaccine was 90.4% effective against symptomatic infection and offered 100% protection against moderate and severe illness—similar to the mRNA vaccines. But Novavax struggled to procure raw ingredients for its vaccine, including plastic bags to grow cells.
Rather than help Novavax increase manufacturing, Wall Street reported that Biden officials bullied Moderna to donate more doses to low-income countries to compensate for the Novavax shortfall.
The Moderna and Pfizer vaccines have been enormous commercial successes because of their flexible mRNA technology and support from regulators who have accelerated their reviews.
The FDA hinders rather than promotes innovation. Consider Lucira Health. In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test.
Lucira applied to the FDA for authorization of its novel test last May and expected to receive a thumbs-up by the end of summer before the flu season started. Canada authorized Lucira's test last August.
The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.
Failures of Covid vaccine maker Novavax Inc (NASDAQ:NVAX) and diagnostic start-up Lucira Health Inc (NASDAQ:LHDX) show that companies often succeed or fail, owing to the whims of the government.
Covid疫苗制造商的失败 Novavax Inc. (纳斯达克股票代码:NVAX)和诊断初创公司 露西拉健康公司 纳斯达克股票代码:LHDX)表明,公司的成功或失败往往是由于政府的异想天开。
Last week, while reporting Q4 earnings, Novavax raised doubts about its ability to remain in business and announced plans to cut spending.
上周,在公布第四季度财报时,Novavax对其继续经营的能力表示怀疑,并宣布了削减支出的计划。
The Covid-19 vaccine was Novavax's first and only commercial product in its 36-year history, Wall Street Journal writes. However, the product flopped after successful trials thanks to regulatory delays and manufacturing hiccups.
《华尔街日报》写道,Covid-19疫苗是Novavax在其36年历史上的第一款也是唯一的商业产品。但是,由于监管延误和制造问题,该产品在成功试用后失败了。
Operation Warp Speed awarded Novavax $1.6 billion to cover testing and manufacturing costs of its experimental vaccine in exchange for 100 million doses if the FDA authorized it.
Operation Warp Speed向Novavax拨款16亿美元,用于支付其实验疫苗的测试和制造成本,如果美国食品药品管理局批准,则换取1亿剂疫苗。
Novavax's struggled to scale manufacturing, which delayed the start of its late-stage U.S. trial to December 2020.
Novavax努力扩大制造规模,这将其后期美国试验的开始推迟到2020年12月。
By then, the FDA had authorized COVID-19 vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE). Yet there was still expected to be enormous demand for its vaccine in low-income countries and among Americans hesitant to get mRNA shots.
那时,美国食品药品管理局已经批准了来自 COVID-19 疫苗 Moderna Inc (纳斯达克股票代码:MRNA)和 辉瑞公司 (纽约证券交易所代码:PFE)。然而,预计低收入国家和对接种mRNA疫苗犹豫不决的美国人仍将对其疫苗有巨大的需求。
Novavax announced in June 2021 that its vaccine was 90.4% effective against symptomatic infection and offered 100% protection against moderate and severe illness—similar to the mRNA vaccines. But Novavax struggled to procure raw ingredients for its vaccine, including plastic bags to grow cells.
Novavax在2021年6月宣布,其疫苗对症状感染的有效性为90.4%,对中度和重度疾病的保护率为100%,类似于mRNA疫苗。但是Novavax很难为其疫苗采购原料,包括用于生长细胞的塑料袋。
Rather than help Novavax increase manufacturing, Wall Street reported that Biden officials bullied Moderna to donate more doses to low-income countries to compensate for the Novavax shortfall.
华尔街报道说,拜登官员没有帮助Novavax提高制造量,而是欺负Moderna向低收入国家捐赠更多剂量以弥补Novavax的短缺。
The Moderna and Pfizer vaccines have been enormous commercial successes because of their flexible mRNA technology and support from regulators who have accelerated their reviews.
Moderna和辉瑞疫苗因其灵活的mRNA技术以及加快审查的监管机构的支持而在商业上取得了巨大的成功。
The FDA hinders rather than promotes innovation. Consider Lucira Health. In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test.
FDA阻碍而不是促进创新。以露西拉健康为例。在一份投资者报告中,Lucira将Covid和流感在家联合测试归咎于FDA的 “漫长” 授权程序。
Lucira applied to the FDA for authorization of its novel test last May and expected to receive a thumbs-up by the end of summer before the flu season started. Canada authorized Lucira's test last August.
Lucira于去年5月向美国食品和药物管理局申请批准其新测试,预计将在流感季节开始前的夏末获得大拇指。去年8月,加拿大批准了Lucira的测试。
The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.
在Lucira申请破产两天后,FDA终于批准了Lucira的测试,并且已经过了流感季节的高峰期。
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在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
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在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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