Business
Successful face-to-face meeting with FDA
Successful face-to-face meeting with FDA.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \nRNS Number : 5131A Angle PLC 22 January 2020 \n\n\n\n\nFor immediate release\n\n\n 22 January 2020\n\n\n\n \nANGLE plc (\"the Company\")\n \nSUCCESSFUL FACE-TO-FACE MEETING WITH FDA TO REVIEW PARSORTIX Q-SUBMISSION\n \nFull De Novo FDA Submission expected in Q1 CY20\n \nProspect of FDA clearance in Q3 CY20 \n \n \nANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that a successful face-to-face meeting with the FDA took place last week. As a result, ANGLE is proceeding with the preparation of the full De Novo FDA Submission for Parsortix®.\n \nAfter completion of clinical and analytical studies demonstrating the performance of the Parsortix system for harvesting circulating tumour cells in metastatic breast cancer, ANGLE made a substantial Q-Submission (a \"pre-submission\" used to request formal comment from FDA on key questions) to FDA on 29 October 2019. This set out headline data from both the clinical and analytical studies and requested FDA formally respond to a series of questions from ANGLE, including whether our responses to specific questions which FDA had previously raised were acceptable. ANGLE's intention in making this Q-Submission was to reduce the risk that the full FDA De Novo Submission might be rejected and to identify any additional work that may be required earlier in the process.\n \nFDA provided a formal written response to ANGLE's Q-Submission in advance of the formal face-to-face meeting with ANGLE held last week to discuss this response. Following the success of this meeting, ANGLE is now able to prepare a full De Novo FDA Submission to FDA requesting clearance of the Parsortix system for use in metastatic breast cancer. While some additional analytical study work was requested by FDA, this will be undertaken in parallel with the submission drafting and have no impact on the overall timescales and incur de-minimis additional cost.\n \nWhilst 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.&...