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Suddenly looks a long way off from a typically impatient aim investor POV.
I would expect positive news flow over the coming months from what todays RNS indicated, SP as expected, sell on the news. I personally think this is one to stay invested in and it will reward the patient longer term investor.
With great respect, Morgank, it it necessary to paste the RNS with the share chat when it is easily seen with a couple of clicks with all the other RNS's? Sorry to be picky.
Ted you have to understand that the process is out of AGL's control. They have been advised to do trails etc for the FDA submission. They have done this all in a prompt and timely maner, they have updated shareholders and in my eyes done an excellent job in the process. The added stuff needed isnt requested from our AGL BOD its from the FDA. We are meerly jumping through the hoops the throw at us. But have clearly stated that its nothing big and will (or should) conclude in Q4 this year ready for submission.
This isnt a setback if you understand the company. Understanding AGL is a long term investment rather than a jam tomorrow stock
Write what off as nonsense?
24th May @15.26. AN again states Angle aiming to submit to FDA middle of the year and expects clearance end year. Five (5) working days later it is all postponed. Again. Best to write it off as nonsense.
Yes, easy to knock and spread nonsense with these bios.
Angle are going for FDA De Novo classification for Parsortix. Submission for approval has slipped from around the end of June to the start of Q4, so slippage of about a quarter. The FDA have a review period of up to 150 days for De Novo applications so they are the timescales according to the Company and the FDA rather than posters on a bulletin board.
Regardless of SP action today, it's great that a small UK bio has managed to take a device through to a pivotal trial, that the trial has met all of its endpoints and shortly they'll be submitting an application for FDA approval for a completely new class of medical device. Good stuff.
Looking forward now to hearing more about the new ovarian cancer study.
Bermuda - thanks
Typical response in this market. If you’ve got 80% positive and 20% negative it’ll go for the negative!
ASCO is the annual meeting of American Society of Clinical Oncology - the biggest oncology scientific conference is the world. Around 40,000 attend each year and it's often used by pharma as a platform to present news and clinical results as it attracts maximum attention.
Angle will be there and I know for sure there are at least 2 or 3 (but probably more) abstracts being presented which feature Parsortix.
Can kicked down the again for another couple of years
Bermuda- what’s ASCO?
Excellent news. The study met its primary and secondary endpoints!
We can only guess as to what additional studies are required but the term 'remaining analytical study work' and the timescales and costs involved don't suggest anything major. In bio terms, a delay of just over a quarter is really very short.
I suspect the timing of today's announcement is no coincidence - the opening day of ASCO
FinnCap say "This is good news, further de-risking the FDA clearance for Parsortix,
which is expected to stimulate increased business development activities. We increase our target price to 130p."
champagne is in order! even though we always knew P. would prove itself and could have drunk it 6 months ago...
Typical that the FDA want extras but, as AN says, it's great they have identified it now, rather than sending the application back (1 year delay, rather than 2 months).
Is it too early in the day for champagne?
A bit of extra analysis to do which adds a bit of extra time to FDA clearance but bureaucracy is to be expected. Also not a surprise that we smashed it on the trial itself, we know how good Parsortix is, but excellent to see it proving itself in the FDA trial and that should encourage interest in what is going on at Angle. To mix some metaphors, we are really knocking on the door now and I'm glad I'm already on board and not going to miss this boat.
Angle PLC Positive Results from FDA Clinical Study
Source: UK Regulatory (RNS & others)
RNS Number : 6723A
31 May 2019
For immediate release 31 May 2019
ANGLE plc ("the Company")
POSITIVE RESULTS FROM FDA CLINICAL STUDY
Analytical studies ongoing to support FDA submission
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce positive results from its Parsortix FDA clinical study for metastatic breast cancer.
The 400 subject ANG-002 clinical study (the Study) was designed to support a De Novo submission to the United States Food and Drug Administration (FDA) seeking Class II regulatory clearance for ANGLE's Parsortix(TM) system for the intended use with metastatic breast cancer patients.
The Study has achieved its primary objective to demonstrate the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients.
The Study has also achieved its exploratory goals by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques, including: Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescent in situ hybridisation (FISH) for evaluation of HER2/neu amplification status, and RT-qPCR for evaluation of cancer related gene expression levels. The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, full bioinformatic analysis is due in June.
ANGLE's ongoing discussions with FDA as part of the De Novo process have recently identified additional analytical study experiments that will be needed to support FDA clearance. It is helpful that these requirements have been identified ahead of FDA submission. The additional studies have minimal cost and are expected to be completed to allow FDA submission in early Q4 CY19 offering the prospect of FDA clearance in early CY20. The timing of FDA regulatory clearance is dependent on the FDA's review and response to our submission.
Further disclosure of data will be reserved to optimise the potential for publication in peer-reviewed journals and to present the data at leading cancer conferences.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"We are delighted with the positive results from the FDA clinical study. We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible.
"We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance(1) 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. This clearance, considered the gold standard for approva
Actually at the main presentation itself, Angle didn't proactively ;-) mention clusters once. It only featured in the Q&A after being raised by an audience member.
Rather, the main focus of Newland's presentation was on personalised medicine and Angle's role within it, focusing on breast and ovarian cancer, HER2, Abbot etc.
Yes very short but still good and you say "clusters" seems to be the favourite word. Looks like things are still on track with regards to FDA.
Below is link to a short synopsis from AN, recorded after his Proactive presentation last night. Clusters, clusters, clusters.
I am assuming the recent drops are just part of the general flight from shares we are seeing at the moment rather than anything specific to Angle as, as far as I can see, nothing has changed and we are still in a waiting period for what we hope and expect is good news.
Some of my other ones being trashed though and the other boards I am on are distinctly unhappy.
Hopefully once we are through this Brexit debacle; there isn't a trade war with China nor a real war with Iran things will pick up.
just got to continue to hold. Everyone knows you could probably trade it to get a couple of extra free shares but just not worth the risk of mistiming the big RNS!
Let’s hope so! But whatever, whenever, this appears to be a professional operation which may not only benefit those invested, but crucially all those at whom the product is directed! (Fingers crossed)!
So what’s going on
May nill nada nix rien nichts
Are we getting ready for the big one
as Jel says, just hold on, with FDA approval the floodgates will open.