RNS - FDA Accept Angles submission20 Oct 2020 08:36
Angle PLC Submission accepted by FDA for substantive review
Source: RNS Non-Regulatory
TIDMAGL
Angle PLC
20 October 2020
For immediate release 20 October 2020
ANGLE plc ("the Company")
ANGLE'S FDA SUBMISSION ACCEPTED BY FDA FOR SUBSTANTIVE REVIEW
Full Class II De Novo FDA Submission seeking clearance of the Parsortix system for metastatic breast cancer has successfully completed FDA administrative review
ANGLE believes that the earliest prospect of FDA clearance is Q2 CY21*
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is pleased to announce that FDA has completed its administrative review and accepted ANGLE's FDA submission for substantive review.
As announced on 28 September 2020, ANGLE has submitted a full Class II De Novo FDA Submission for its Parsortix(R) 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."
* ANGLE is following a De Novo FDA process for Parsortix, as there is no predicate device. Consequently, there is inherent uncertainty over the timing of the process and its ultimate success.
For further information:
ANGLE plc +44 (0) 1483 343434
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
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