Business
Update on submission for FDA clearance
Update on submission for FDA clearance.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 8000A\n Angle PLC\n 04 June 2021\n \n \n \n \n \n \n \n \n For immediate release\n \n \n \n \n 4 June 2021\n \n \n \n \n \n \n \n \n \n ANGLE plc (\"the Company\")\n \n \n \n \n \n UPDATE ON SUBMISSION FOR FDA CLEARANCE OF THE PARSORTIX SYSTEM \n \n \n \n \n \n Response to Additional Information Request made to FDA as planned\n \n \n \n \n \n ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, confirms \n that it has completed the work required to answer questions raised by FDA in its Additional Information Request and that a comprehensive response has been submitted to FDA as planned.\n \n \n \n \n \n In line with industry best practice ANGLE does not intend to provide any further updates on communication with FDA regarding the submission whilst the regulatory process is as expected. ANGLE continues to anticipate a regulatory decision from FDA during H2 CY 2021*.\n \n \n \n \n \n ANGLE Founder and Chief Executive, Andrew Newland, commented:\n \n \n \"We are pleased to have submitted a comprehensive response to FDA's request for additional information and look forward to FDA completing its substantive review.\"\n \n \n \n \n \n *ANGLE is following a De Novo FDA process for the Parsortix system, as there is no predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success.\n \n \n \n \n \n For further information:\n \n \n \n \n \n \n \n \n \n ANGLE plc\n \n \n \n \n +44 (0) 1483 343434\n \n \n \n \n \n \n Andrew Newland, Chief Executive\n \n \n Ian Griffiths, Finance Director\n \n \n Andrew Holder, Head of Investor Relations\n \n \n \n \n \n \n \n \n \n \n \n \n finnCap Ltd (NOMAD and Joint Broker)\n \n \n Corporate Finance - Carl Holmes, Simon Hicks, Teddy Whiley\n \n \n ECM - Alice Lane, Sunila de Silva \n \n \n \n \n \n \n \n +44 (0)20 7220 0500\n \n \n \n \n \n \n \n \n \n WG Partners (Joint Broker)\n \n \n Nigel Barnes, Nigel Birks\n \n \n \n \n \n \n \n +44 (0) 203 705 9330\n \n \n \n \n \n \n \n \n \n \n \n \n FTI Consulting\n \n \n Simon Conway, Ciara Martin\n \n \n Matthew Ventimiglia (US) \n \n \n \n \n \n \n \n \n \n \n +44 (0) 203 727 1000\n \n \n +1 (212) 850 5624\n \n \n \n \n \n \n \n \n \n Fo...