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yes, great news this morning - so, March at the earliest it seems. Let's hope for news on other fronts in the meantime...
I had read the RNS as saying the 150 days are calculated from the date the FDA received the application, ie 28th September. Only about 3 weeks difference so of little consequence in the whole scheme of things. April would be good, I don't expect a Christmas present from Angle or FDA!
I doubt it would be newsworthy enough - unless there was a serious delay.
are we likely to get any further RNS updates on the progress of FDA approval or is that it now until we find out whether its a yes or a no?
Given the advance discussions between FDA and Angle earlier this year on what was needed for the de novo submission, one might hope that there would not much unexpected delay from now on. I assume the clock starts ticking from the moment of administrative acceptance, and so 150 days from now takes us to late March. I think AN is putting in 2-3 weeks of extra time for queries, but i am still hoping that we will hear in April.
corr - Angle's
A refusal to accept notice would have added a minimum of several weeks delay so really good news to see Angles' application move smoothly to substantive review.
so now aiming for clearance in april-june time. now is just a waiting game until that news comes out.
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
finnCap Ltd (NOMAD and Joint Broker)
Corporate Finance - Carl Holmes, Simon
Hicks
ECM - Alice Lane, Sunila de Silva +44 (0)20 7220 0500
WG Partners (Joint Broker)
Nigel Barnes, Nigel Birks, Andrew Craig,
Chris Lee +44 (0) 203 705 9330