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Angle's parsortix system gets nod for substantive review in US
StockMarketWire.com
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Liquid biopsy company Angle said its parsortix system for metastatic breast cancer had been accepted for substantive review by US health authorities.
The company said it expected the earliest clearance for the platform could be received in the second quarter of 2021.
The acceptance review 'is a formal process undertaken by FDA to determine that the submission contains all of the necessary elements and information needed by FDA to proceed with substantive review,' the company said.
The US Food and Health Administration's goal is to make a decision about a De Novo request in 150 review days, though the review clock stops, when FDA requests further information or clarification from the company.
At 9:52am: (LON:AGL) Angle PLC share price was 0p at 51p
Story provided by StockMarketWire.com
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