Genetic Signatures (GSS) - FDA Review Nearing the Finish Line
GSS is approaching a potentially transformative milestone, as the FDA review of its 510(k) application for clearance to market its EasyScreen...
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Genetic Signatures (GSS) - On Track for Potential US Launch Mid-Year
GSS expects to submit responses by the end of April to FDA questions regarding its 510(k) application to market the GIP kit in the US.
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Genetic Signatures (GSS) - Preparing for Potential US Launch H2 FY24
The FDA review for 510(k) applications takes between 3 and 9 months, so we expect an FDA decision between December 2023 and June 2024.
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Genetic Signatures (GSS) - Sales Disappoint but Key Catalyst Approaching
GSS reported $2.0m sales in Q323, falling below our expectations as Covid and other respiratory testing tailed off more quickly than we had...
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Genetic Signatures (GSS) - FDA Clearance Remains Key Despite Submission Delay
The FDA submission is now expected before the end of April vs AGM guidance targeting December and our assumption of Q1 CY23.
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