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Pin to quick picksANGLE Share News (AGL)

Share Price Information for ANGLE (AGL)

London Stock Exchange
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Share Price: 121.00
Bid: 120.00
Ask: 122.00
Change: 7.50 (6.61%)
Spread: 2.00 (1.67%)
Open: 113.50
High: 121.00
Low: 113.50
Yest. Close: 113.50
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FDA accepts Angle's review submission for Parsortix PC1

Tue, 20th Oct 2020 08:58

(Sharecast News) - 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.

More News

IN BRIEF: Angle's Parsortix system gets Italian research boost

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29 Apr 21 12:22

IN BRIEF: Angle enrolls 200 patients for ovarian cancer test study

IN BRIEF: Angle enrolls 200 patients for ovarian cancer test study

26 Apr 21 12:02

Angle completes patient enrolment for ovarian cancer study

(Sharecast News) - Liquid biopsy company Angle announced on Monday that its 200-patient ovarian cancer clinical verification study had completed patient enrolment.

26 Apr 21 11:38

UK earnings, trading statements calendar - next 7 days

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22 Apr 21 16:10

Angle secures first large-scale pharma services contract

(Sharecast News) - Liquid biopsy company Angle has secured its first large-scale pharma services contract, it announced on Friday.

16 Apr 21 12:31

TRADING UPDATES: AFC raises GBP36 million; Angle wins service contract

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IN BRIEF: Angle launches clinical services laboratories in UK and US

IN BRIEF: Angle launches clinical services laboratories in UK and US

30 Mar 21 20:38

Angle completes clinical labs in Guildford and Pennsylvania

(Sharecast News) - Liquid biopsy company Angle has completed the fitout and staffing of its clinical services laboratories in Guildford and Pennsylvania, it announced on Tuesday.

30 Mar 21 15:39

TRADING UPDATES: Futura signs development deal; UKOG gets day in court

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AIM WINNERS & LOSERS: Futura Medical rises on financing transaction

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4 Mar 21 11:42

Angle Shares Jump On Recent Parsortix System Research Results

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18 Feb 21 10:24

IN BRIEF: Angle Says Athens University Study Shows Value Of Parsortix

IN BRIEF: Angle Says Athens University Study Shows Value Of Parsortix

8 Feb 21 17:09

TRADING UPDATES: Character Extends Peppa Pig Deal; Dekel Raises Cash

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Angle Reports Parsortix System Can Isolate Circulating Tumour Cells

Angle Reports Parsortix System Can Isolate Circulating Tumour Cells

20 Jan 21 12:22

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