RBC Out With Note On QuidelOrtho Saying "After Speaking To Management No Change At QuidelOrtho; Company Withdraws Original Savanna RVP4+ Assay From FDA 510(k) Submission, Plans Resubmission Ahead Of 2024/2025 Respiratory Season
Portfolio Pulse from Benzinga Newsdesk
RBC released a note on QuidelOrtho, indicating no change in the company's status after speaking with management. QuidelOrtho has withdrawn its original Savanna RVP4+ Assay from the FDA 510(k) submission and plans to resubmit it before the 2024/2025 respiratory season.
April 02, 2024 | 4:19 pm
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QuidelOrtho withdrew its Savanna RVP4+ Assay from FDA 510(k) submission, planning a resubmission before the 2024/2025 respiratory season, as reported by RBC.
The withdrawal and planned resubmission of the Savanna RVP4+ Assay by QuidelOrtho may not have an immediate impact on the stock price, as the market may have already anticipated such regulatory maneuvers. However, the company's proactive approach to addressing FDA concerns and planning for a future submission could be viewed positively in the long term.
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