ANGLE PLC (LON:AGL OTCQX:ANPCY) said it has been asked by the US Food & Drug Administration for additional information to support its submission for De Novo clearance of its Parsortix PC1 liquid biopsy system.
The company said the request “was expected and is in line with typical De Novo clearance processes”. The additional work should be completed and submitted by early May, it added.
ANGLE said it was unclear how quickly the FDA would or could respond given its allocation of resources to COVID-19 priorities.
So, clearance, if granted, would occur in the second half of 2021 rather than the previous guidance of the "earliest prospect of FDA clearance being Q2 CY21", the firm explained.
Founder and chief executive Andrew Newland said: "We are encouraged that, whilst there is an element of new work needed, this does not require the acquisition of further time-consuming patient samples.
“ANGLE has mapped out a comprehensive and positive response to FDA's request and is confident that this can be submitted as planned.
“We appreciate the current pressure on FDA resources, given COVID-19 priorities and thank the Agency for the progress already made with the substantive review.”