CEMI - Chembio Diagnostics drops 20% after FDA declined to review EUA application for COVID/Flu test

Chembio Diagnostics (NASDAQ:CEMI) down 20% premarket after the FDA notified the company that it was declining to review its application for an emergency use authorization (EUA) for the DPP Respiratory Antigen Panel. The Agency informed CEMI that, in order to proceed, the company will need to prospectively collect Influenza A and Influenza B samples and then submit a new EUA application for the DPP Respiratory Panel. In an 8-K filing, the company said that, "We cannot assure you that we will be able to compile the additional specimens requested by the FDA in a timely manner or at all, and therefore we cannot assure you that we will be able to submit a new EUA application for the DPP Respiratory Antigen Panel at any specific time in the future or at all." The DPP Respiratory Antigen Panel is a test system designed to provide simultaneous, discrete and differential detection of SARS-CoV-2, Influenza

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Chembio Diagnostics drops 20% after FDA declined to review EUA application for COVID/Flu test