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BRIEF-Trinity Biotech announces withdrawal of Troponin FDA 510(k) submission
October 4, 2016 / 12:47 PM / a year ago

BRIEF-Trinity Biotech announces withdrawal of Troponin FDA 510(k) submission

Oct 4 (Reuters) - Trinity Biotech Plc

* Trinity biotech announces withdrawal of Troponin FDA 510(k) submission

* FDA asked trinity to consider withdrawing their submission, due to some concerns they have about submission

* To move technology from swedish facility to facility in ireland where it will be incorporated into research and development,manufacturing infrastructure

* Moving of technology will result in closure of uppsala facility in sweden, which will result in approximately 40 redundancies

* Trinity biotech announces withdrawal of troponin fda 510(k) submission

* Held a meeting with fda on thursday 29 september, in order to obtain an update on company’s meritas troponin submission

* Fda asked trinity to consider withdrawing their submission, due to some concerns they have about submission

* Fda’s primary concerns relate to device’s operating temperature range

* “over coming weeks we will engage with fda to gain a better understanding of nature of their concerns”

* Fda concerns also relate to troponin-i clinical performance not being consistent with clinical performance data

* Will also recognise a non-cash write-off in excess of $50m, representing costs incurred on project, which will be recognised in q4 Source text for Eikon: Further company coverage:

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