ANGLE confirmed positive results from the analytical studies. To ensure the De Novo filing process for Parsortix, as the first liquid biopsy system to capture and harvest Circulating Tumour Cells (CTC) for subsequent analysis, proceeds as smoothly as possible, ANGLE has elected for a Pre-Submission (Pre-Sub) meeting with the FDA to ensure that data it intends to submit in the De Novo application for Parsortix fully meets their needs. This is a sensible de-risking strategy designed to minimise the overall timescales for clearance by addressing FDA questions early. Whilst this pushes back our previous expectation for the full De Novo filing from early Q4 2019 to Q1 2020, the overall timing for clearance remains similar at Q3 2020 and the De Novo regulatory process is de-risked as much as possible. We reiterate a 135p target price.
Mark Brewer 020 7220 0556 mbrewer@finncap.com
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