Cue Health Says Letter Shows FDA Determined Further Review Of Co's EUA Request Is Not Priority, Therefore Declines To Issue EUA For Product At This Time; Expects Payments Relating To The CRP To Be Completed By The End Of Q3 Of 2024
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Cue Health announced that the FDA has decided not to prioritize the review of the company's Emergency Use Authorization (EUA) request for its product. As a result, the FDA has declined to issue an EUA at this time. Cue Health expects that payments related to the CRP will be finalized by the end of Q3 2024, according to a recent SEC filing.
January 05, 2024 | 9:19 pm
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NEGATIVE IMPACT
Cue Health's EUA request for its product is not being prioritized by the FDA, leading to no EUA being issued at this time. The company anticipates completion of CRP-related payments by end of Q3 2024.
The FDA's decision not to prioritize Cue Health's EUA request could be seen as a negative development for the company, potentially impacting investor sentiment and the stock price in the short term. The delay in obtaining an EUA could hinder the company's ability to bring the product to market promptly, affecting revenue expectations. However, the expectation of completing CRP-related payments by Q3 2024 provides a timeline for financial clarity.
CONFIDENCE 90
IMPORTANCE 80
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