On October 20, 2020 ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, reported that FDA has completed its administrative review and accepted ANGLE’s FDA submission for substantive review (Press release, ANGLE, OCT 20, 2020, View Source [SID1234568786]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As announced on 28 September 2020, ANGLE has submitted a full Class II De Novo FDA Submission for its Parsortix PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission"). ANGLE has now received an Acceptance Review Notification from FDA that the Submission has been accepted. The administrative 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 Submission is the output of five years’ work including extensive dialogue with FDA, and the development of over 400 technical reports and documents, which have been submitted to FDA.

FDA’s goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by FDA and the date of FDA’s decision. The review clock stops, however, when FDA requests further information or clarification from the Company. ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21.*

ANGLE Founder and Chief Executive, Andrew Newland, commented:

"We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review. We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer."