share_log

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

FDA 的監管延遲是諾瓦克斯，盧西拉健康失敗的原因：WSJ 報告
Benzinga ·  2023/03/07 13:31

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 疫苗製造商的失敗 諾瓦克斯公司 (NASDAQ: NVAX) 和診斷啟動 盧西拉健康公司 （NASDAQ：LHDX）表明，由於政府的奇想，公司經常成功或失敗。

Last week, while reporting Q4 earnings, Novavax raised doubts about its ability to remain in business and announced plans to cut spending.

上週，在報告第四季度盈利時，Novavax 對其保持業務的能力提出了懷疑，並宣布了減少支出的計劃。

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.

華爾街日報寫道，Covid-19 疫苗是諾瓦克斯 36 年歷史上第一個也是唯一的商業產品。但是，由於監管延遲和製造打嗝，該產品在成功試用後失敗。

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.

如果 FDA 授權，經速操作授予 Novavax 16 億美元，用於支付其實驗疫苗的測試和製造成本，以換取 1 億劑劑量。

Novavax's struggled to scale manufacturing, which delayed the start of its late-stage U.S. trial to December 2020.

諾瓦克斯努力擴大製造業規模，這將其美國後期試驗的開始延遲到 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.

到那時，美國食品和藥物管理局已授權 COVID-19 疫苗 現代公司 (納斯達克:MRNA) 和 輝瑞公司 (紐約證券交易所:PFE).然而，在低收入國家和美國人中，仍然預計對其疫苗的巨大需求仍然猶豫要接種 mRNA。

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.

諾瓦克斯（Novavax）於 2021 年 6 月宣布，其疫苗對症狀感染有效達 90.4％，並提供 100％ 的中度和重度疾病保護，類似於 mRNA 疫苗。但是諾瓦克斯努力為其疫苗採購原料，包括塑料袋以生長細胞。

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.

華爾街報導說，拜登官員欺負 Moderna 向低收入國家捐贈更多劑量，以彌補 Novavax 的短缺，而不是幫助諾瓦克斯增加製造業。

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 和輝瑞疫苗在商業上取得了巨大的成功，因為它們具有靈活的 mRNA 技術以及加速審查的監管機構的支持。

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 阻礙而不是促進創新。考慮盧西拉健康。在一份投資者報告中，盧西拉（Lucira）歸咎於 FDA 的「長期」授權流程，以進行 Covid 和流感在家中進行聯合 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.

Lucira 去年 5 月向 FDA 申請了其新型 test 的授權，並預計在夏季結束前將在流感季節開始之前獲得大拇指。加拿大去年八月批准了盧西拉的 test。

The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.

FDA 終於批准了 Lucira 的 test，在申請破產和過去流感季節高峰後的兩天。

声明：本內容僅用作提供資訊及教育之目的，不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論