FDA accepts Angle's review submission for Parsortix PC1
Liquid biopsy company Angle announced on Tuesday that the US Food and Drug Administration (FDA) has completed its administrative review, and accepted the company’s submission for substantive review.
The AIM-traded firm had announced on 28 September that it submitted a full Class II De Novo FDA submission for its ‘Parsortix PC1’ system, seeking clearance for use with metastatic breast cancer patients.
It said on Tuesday that it received an Acceptance Review Notification from the FDA, that the submission had been accepted.
The administrative acceptance review was a formal process undertaken by the FDA, to determine that the submission contained all of the necessary elements and information needed by the administration to proceed with a substantive review, the board explained.
It said the submission was the outcome of five years of work, including “extensive dialogue” with the FDA, and the development of more than 400 technical reports and documents, which had been submitted to the FDA.
Angle said the FDA's goal was to make a decision about a De Novo request in 150 review days, which are calculated as the number of calendar days between the date the De Novo request was received, and the date of its decision.
The review clock stops, however, when the FDA requests further information or clarification from the company.
Angle said it believed that the earliest prospect of FDA clearance was the second quarter of the 2021 calendar year.
“We are pleased that our FDA submission has successfully completed FDA administrative review and is now in substantive review,” said Angle founder and chief executive officer Andrew Newland.
“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.”
At 1337 BST, shares in Angle were down 3.9% at 49.01p.