GSS 1.32% 75.0¢ genetic signatures limited

More delays to US FDA application

  1. 396 Posts.
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    Yet more unexplained delays and lack of accountability from Genetic Signatures.

    Now GSS is saying it will submit its Enteric Protozoan Diagnostic Kit application to the FDA "before the end of April 2023."

    This compares to what they said at their AGM on 16 November 2022: "Targeting 510(k) submission in Q4 CY2022." In other words, with 6 weeks until the end of calendar year 2022, GSS said it would make its submission by the end of 2022.

    This can be further compared to what they said in their quarterly update of 26 April 2022: "In the United States (US), clinical trials for the FDA application for registration of the EasyScreen Protozoan Detection Kit have progressed well. Final collection of 1,500 samples will be done this quarter, after which data analysis will be undertaken and the submission completed."

    Are the Chairman, CEO and Board of GSS accountable or not accountable for these continuing delays? What is going on?
 
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