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6 months minimum quoted in RNS
The ctDNA guys will not be happy today, but they must have known it was coming. however, I am not sure of the overlap between Parsortix and the ctDNA process mentioned in Sunday Times yesterday. Parsortix is not (at present) into early primary diagnosis of cancer, which the ctDNA guys are promoting. This technique is fraught with problems, and anyway i do not think there is much purpose in looking for 30 different cancers. instead, if the ctDNA process is to be useful it should focus on the big killers whose presentation may be occult, like small cell lung, breast, pancreas etc,.
Longlad, it will take at least 3 months I believe - the 6 month estimate takes account of the urgent C-19 vaccine submissions...
However, there is other research being done in the meantime that will lift the SP in anticipation of FDA approval. I hope today when the US wakes up, the big investors there will top up to the60p at which they bought in - that price would be my prediction for close of play today.
Can take upto 6 months, but can you afford to be out of the stock, it could come at anytime
A great well run company with tremendous prospects. When (not if) it gets full FDA clearance it may well become a fertile battleground for a take over by the large Pharma companies.
Is there any guidance as to how long the FDA process takes to get an outcome?
Given the market opportunity they elude to. I'm hoping those numbers might turn out to be rather Conservative.
Marvellous!
Wonderful that they hit their Covid-revised target, and during that period received 2 further independent endorsements. The submission is a monster, but it reads as if the Q process has taken away any uncertainty. 6 months sounds reasonable for the time the FDA might take, especially given the quantity of C-19 vaccines to trawl through at present. I also like that in the information there is clearly a pipeline of new applications. Well done AN and team - let's hope they easily achieve the intended X3.7 share increase over the next three years - so about £2, though I recall the US investors want to wait for £5!
Brilliant news, I was worried that with covid picking up again they may not get the final tests finished.
Hopefully their Q -submission should have flagged any issues so there are no further delays.
Brilliant news. A huge milestone for Angle and potentially for the field of CTC liquid biopsies.
This is a very substantial achievement and a seminal moment in the development of Angle. Well done to Andrew Newland and his excellent company. He sounds very upbeat and confident.
Angle PLC ANGLE announces completion of FDA submission
Source: UK Regulatory (RNS & others)
TIDMAGL
RNS Number : 2189A
Angle PLC
28 September 2020
For immediate release 28 September 2020
ANGLE plc ("the Company")
ANGLE ANNOUNCES COMPLETION OF FDA SUBMISSION
Full Class II De Novo FDA Submission seeking clearance of the Parsortix system for metastatic breast cancer
Potential to be the first ever FDA clearance for a system to harvest intact cancer cells from a simple blood draw for subsequent analysis
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that it has submitted a full De Novo FDA Submission for its Parsortix(R) PC1 system seeking FDA clearance for use with metastatic breast cancer (MBC) patients ("the Submission").
The Submission provides a data package demonstrating the performance of the Parsortix system in harvesting cancer cells from MBC patient blood for subsequent analysis. The directors believe that the capability to harvest these cells provides the potential for a wide range of downstream analyses, which may transform the treatment of cancer, providing patients with personalised cancer care through a non-invasive, repeat biopsy based on a simple blood test (a "liquid biopsy").
Submission details
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 now been submitted to FDA. The characterisation of the system included the assessment, inter alia, of performance with clinical samples, recovery, linearity, limit of detection, reproducibility, repeatability, blood volume, blood stability and interfering substances both exogenous and endogenous, requiring over 15,000 samples to be run on the Parsortix system in the UK and at clinical sites in the United States. This process, combined with the manufacture of the Parsortix system and associated consumables, has been completed and fully documented under ANGLE's ISO 13485 quality system and in compliance with numerous other technical and quality standards active in the United States and Europe. The Submission has also been designed to meet the requirements for European CE Mark and, if granted clearance by FDA in the United States, ANGLE intends to register for European CE Mark clearance allowing clinical sales in both the United States and Europe for the intended use.
We are most grateful to over three hundred MBC patients at four leading US cancer centres and several thousand healthy volunteer donors, who have donated blood to allow us to undertake the extensive studies necessary for the Submission.
Market potential
ANGLE intends that the Parsortix system will eventually be adopted worldwide. Cowen Equity Research estimate the market opportunity for liquid biopsy in the United States alone to be up to US$ 130 billion per annum.
The current National Cancer Guidelines in the