May 24, 2017 / 6:12 AM / 2 months ago

BRIEF-Curetis reiterates it expects FDA to provide decision on clearance of Unyvero LRT in H2 2017

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May 24 (Reuters) - Curetis Nv:

* CURETIS PROVIDES UPDATE ON UNYVERO LRT FDA 510(K) SUBMISSION

* CURETIS REITERATES THAT IT EXPECTS FDA TO PROVIDE DECISION ON CLEARANCE OF UNYVERO LRT IN SECOND HALF OF 2017

* PLANS TO CONTINUE WORKING CLOSELY WITH FDA REVIEWERS TO IDENTIFY AN APPROPRIATE PATH TO DEVELOP OR AUGMENT BAL DATA PACKAGE

* TOTAL NUMBER OF ADDITIONAL UNYVERO LRT APPLICATION CARTRIDGE RUNS IS EXPECTED TO BE AROUND 500 TO 1,000 AND WILL LIKELY BE COMPLETED IN COMING 3 TO 4 MONTHS Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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