March 3, 2021
ANGLE plc today announced that, following substantive review of ANGLE’s FDA submission requesting De Novo clearance of the Parsortix® PC1 system, FDA has provided a written response in the form of an Additional Information Request (AIR).
Receipt of an AIR was expected and is in line with typical De Novo clearance processes. ANGLE is confident of being able to provide a full response to all the information requests raised.
Some of the technical information requested necessitates some targeted additional analytical studies. However, these additional analytical studies do not require patient samples and ANGLE anticipates that the necessary studies, which are already at an advanced planning stage, can be completed and the response submitted by early May.
In its communication with FDA, ANGLE has been advised that, due to the unprecedented allocation of resources to COVID-19 priorities, it is currently unclear how quickly FDA will be able to review ANGLE’s response to the AIR once it has been submitted.
Whilst there has not been a delay to date, taking into account the possibility that FDA processes are delayed, it is now more likely that FDA 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”. ANGLE notes that FDA processes are outside the Company’s control and ANGLE is continuing to expedite all aspects of the process which are under its control in line with previously advised timescales.
ANGLE Founder and Chief Executive, Andrew Newland, commented: “The Additional Information Request is largely as expected consisting of questions and clarifications. 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.”
He concluded, “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.
Separate from FDA product clearance, ANGLE is continuing to make encouraging progress towards the establishment of clinical laboratories and the development of a new pharma services business and looks forward to announcements in relation to these in due course.”
* 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.