Shares of Chembio Diagnostics, Inc. (CEMI) are falling more than 17% Friday morning at $6.17.
In an SEC filing on Thursday the company reported that the FDA is not prioritizing the Emergency Use Authorization application submitted by the company for its DPP SARS-CoV-2 Antigen test system.
Chembio’s DPP SARS-CoV-2 IgM/IgG test was submitted to the regulator for EUA in September.
“The response letter states that, given the volume of EUA requests it has received, the FDA is prioritizing review of EUA requests for tests, taking into account a variety of factors such as the public health need for the product and the availability of the product. The response letter further states that the FDA has determined that review of the IgM/IgG EUA request is not a priority because, for example, authorization of the test would have relatively limited impact on testing accessibility or testing capacity, and therefore the FDA has declined to review the IgM/IgG EUA request at this time,” the company said in the filing.
Chembio stock has been trading in the range of 2.25- $15.89 in the past 52 weeks.
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