On February 16, 2021, Meridian announced “an update on its application for Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration” for Meridian’s SARS-CoV-2 molecular diagnostic test on the Company’s Revogene® platform. In this announcement, Meridian advised investors that “[i]n its ongoing discussion with he FDA, late in the day on Friday, February 21, 2021, the Company received further correspondence requesting additional information on the SARS-CoV-2 molecular diagnostic test,” and that Meridian “has elected to place shipments of the SARS-CoV-2 test kits on hold while it continues to work with the FDA.” On this news, Meridian’s stock price fell $3.70 per share, or about 12.4%.
Then before the markets opened on February 23, 2021, Meridian announced that after “further discussions with the FDA, on February 22, 2021, Meridian Bioscience elected to withdraw its EUA application. Between now and the end of March 2021 and based upon guidance from the FDA, Meridian intends to conduct a new clinical validation study and a Limit-of-Detection bridging study, with the intention of re-submitting an EUA application . . . as soon as possible thereafter. Upon notification of the FDA of its intent to re-submit an EUA application, during its third fiscal quarter, Meridian expects to resume shipping of this test to customers.” However, during the trading day on February 23, 2021, Meridian issued another press release correcting its earlier announcement, now saying that after “subsequent communication with the FDA mid-morning on February 23, 2021, the FDA clarified that Meridian will not be able to distribute its SARS-CoV-2 molecular diagnostic test on its Revogene® platform until the test receives EUA approval from the FDA.” On this news, the stock fell again and is down approximately 9% in intraday trading.