(Alliance News) - Liquid biopsy company Angle PLC on Wednesday said it expects its Parsortix cancer treatment to secure US Food & Drug Administration consent later this year, following a "successful" face-to-face meeting with the regulator.
Following the meeting last week, Angle will file an FDA submission during the first quarter of this year, and anticipates full clearance by the third quarter.
Angle added: "Whilst significant work remains to complete the written submission, which is expected to run to several thousand pages, all of which will be subject to substantive review and questioning by FDA, Angle believes that all of the critical issues were addressed in the meeting and that there is now a clear route to full de novo FDA submission."
Angle in October said it is following the de novo regulatory submission pathway for its Parsortix system. This is used when a product is considered "novel" by the FDA, with no similar product already on the market.
Angle shares were 4.4% higher at 65.95 pence each in London on Wednesday morning.
By Eric Cunha; ericcunha@alliancenews.com
Copyright 2020 Alliance News Limited. All Rights Reserved.
Angle (AGL)