Cue Health Got Response Letter From FDA On Dec 28 On EUA Submission For Flu A/B + Covid-19 Molecular Test For Over The Counter And Point Of Care Use
Portfolio Pulse from Benzinga Newsdesk
Cue Health received a response letter from the FDA on December 28 regarding their Emergency Use Authorization (EUA) submission for a combined Flu A/B and COVID-19 molecular test, intended for over-the-counter and point-of-care use, as disclosed in an SEC filing.
January 05, 2024 | 9:18 pm
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NEUTRAL IMPACT
Cue Health's FDA response for their combined Flu A/B and COVID-19 test could affect the company's product pipeline and market potential.
The FDA's response is a critical step in the regulatory process for Cue Health's new diagnostic product. While the content of the FDA's letter is not disclosed, it is a direct factor in the company's ability to bring the test to market. The impact on the stock price is uncertain without knowing whether the FDA's feedback was positive or negative, hence a neutral score is given. The relevance is at maximum since it directly affects Cue Health's product. The importance is high as the authorization of the test could significantly impact the company's product offerings and revenue potential. Confidence is set at 80 due to the lack of detail on the FDA's feedback.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 100