The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
I think what Bermuda is implying and rightly so is that getting UK / EU approval means nothing without FDA approval because as Phantom says, FDA carries far more weight.
Essentially FDA approval is almost certainly enough to be approved for UK / EU approval and be adopted for UK /EU clinical use, but UK / EU approval is not enough without FDA approval first as no one would adopt it in the clinical setting without FDA approval.
The Lab Based Tests being introduced for Ovarian etc that don't require FDA approval (just CLIA accredited labs) - that is a whole different kettle of fish of course.
Not 'Andrew' as in AN (CEO of AGL) - is simply referring to Andrew who is a well respected and knowledgeable poster - mainly on a ADVFN and the Telegram Group.
From a 'business' point of view, the concept of protection of revenue stream for drug makers as a reason for ignoring anything that helps with 'early diagnosis' or 'reduction in cost' makes good business sense if one thinks about it - whether that is ethical or not, and of course we can't fully dismiss this as is a hypothetical possibility.
Even if it really does happen, I am a somewhat confused how this could be in any way detrimental to Angle because I was under the impression that Parsortix was the 'enabling' technology in order to allow doctors to make clinical decision for the use of even more of these new generation of very expensive 'personalised care' drugs to be used within the market - all the ones that these Big Pharmaceutical companies have been developing and want to start mass use in the clinical market.
I would have thought that those sat on the board of these big pharma companies will be itching to have access to Parsortix !!?
Having 'friends' in influential positions in the FDA probably is a thing. One could say that's how the 'oil of society' works whether we like it or not or if its right or wrong or against the rules.
With regard to the business concept of cost saving being a reason to reject for the same reasons of being bad for big business profits, the way I see this is that the 'cost saving' message from Angle is directed toward health services (alternative to Surgical Biopsy) rather than less expenditure on the treatments. One could argue that this is also against the concept of profit making for 'Insurance Providers', but there are always going to be arguments in the balance for any disruptive ground breaking technologies coming to market.
Would be interested on other thoughts on this :)
Cheers, Buzz
jakeyork "can you elaborate on that a little please."
Sorry for delay - have been making the kids lunch :D
yes - although chester18 perfectly summed up what I meant.
Thanks chester18
Quite simply - Grail and Parsortix don't do the same thing.
You are Wrong!
There you go ;D
Parsortix opens up a huge market for expensive personalised oncology drugs that require in depth diagnostic of a Patients exact disease to enable all these new expensive drugs coming to market to be administered correctly.
Parsortix are the enabling technology that offer the level of diagnostic required for many of these new drugs to be used in the clinical market.
Parsortix is also a companion diagnostic for downstream analysis for example Abbotts offering for MBC as used in the trial for the FDA submission. Abbotts Fish probe technology currently on it's own can only be used once on a solid tissue biopsy at presentation, but in conjunction with Parsortix liquid biopsy, Abbott will be able to offer their diagnostic multiple times for each patient.
Large Pharma will beat a path to Angle's door in order to increase their own revenues.
Ouch Jake, cut and run timing not great with the healthy rebound straight after. That's the sort of thing that happens to me usually! Hope to see you back with more conviction sometime soon.
All the best.
I would think AGL have taken a smart tactical approach to Patent protection of their technology in that they have created enough patent detail to sufficiently cover the unique approach to their design, but have held back a sufficient amount of IP from the Patent description to hold this as a trade secret.
When you consider that AGL's offering, although simplistic in it's concept and no doubt easy to reverse engineer / copy - much of the success/accuracy of the diagnostic product as a whole is no doubt held via IP trade secrets and huge quantities of data that are closely held by AGL.
There is a vast amount of detail in the the overall process of perfection of all the component parts working seamlessly, and in the use of all the test and trial data accumulated over the years, not just in the consumable, but the processing equipment, the algorithms perfected when used with downstream diagnostic equipment - whether that is AGL's own Ziplex system or another company like Abbots Fish HER2 diagnostic equipment.
Even if someone did attempt to copy Parsortix system - simply copying the details available on the Patent protection is nowhere near enough information to have a competitive alternative up and running in double quick time, especially with trials and FDA process taking so many years.
It is certainly a major barrier to entering the market in the first few years and gives AGL a huge buffer for market penetration.
Happy to hear others thoughts on that :)
Thanks researcher1 and miavoce.
I'm now wondering where the info came from that I and others have been working from with the indicated 150 'review days / industry days' as is different to the info on page 14 of the FDA document in the link.
I may be wrong, however I would assume most employees at the FDA work 5 days a week like most of the worlds population.
By my calculation, 150 review days would be 30 weeks, which, from September 25th would take us to the earliest decision around the end of April assuming no questions - my gut feel of later than April is far more realistic as it is no doubt quite reasonable to assume that even if the submission is supremely thorough and addresses all requests for more data that came from the Q-submission, at some point, there will be some technical wording within thousands of pages of text which is somewhere going to need some clarification by AGL - just so the FDA are sure they have interpreted it correctly even if nothing is a show stopper!
Anyone else have any thoughts on the potential timeline?
Enteleon, I was indeed at both the 2018 and 2019 AGM's.
Many thanks for your clarification - your notes are clearly superior to my memory and the few notes I made myself.
I guess I didn't pick up on the moment AN mentioned the FDA insisted on the rf chip, but I do remember the gentleman in the audience talking about other benefits that are possible with this technology and AN wishing to talk with him later.
Yes, you're right, the attendees certainly did ask many good questions, and it was comforting to see that the board where happy to sit through and answer all questions no matter how awkward the questions or how long it took.
Although only a handful of people turn up to these events, it was surprising to see how engaged the attendees are with the intricate details of Parsortix, and also how few appeared to be from Institutional Investors, although I have a feeling this may change as we gain market traction. For me it was the fist time I had gone to the trouble of going to an AGM.
I have held AGL for many years, initially for my interest in Geomerics smart phone graphics lighting software (I work in the graphics industry), which was sold off some years back and is now owned by ARM.
Today it makes me chuckle when I remember my first purchase of Angle shares was actually the only trade of the day and although just a few thousand pounds, the share price lifted immediately after and added a huge amount to the mkt cap :D
It was soon apparent how interesting it was to see Angle's Parsortix technology progressing and the clear direction to change focus entirely on this product. So from the early days I have been following this and have become progressively ever more confident of the technology they have developed.
As I was looking to increase my investment, I figured it made good sense to not only listen to what is said, but gauge from body language and that extra gut feeling you get from face to face encounter.
Post Q & A session and Lab tour, AN was happy to sit with us informally in a circle of chairs and listen/answer further questions from those hanging on.
I have since grown my investment quite substantially, and much of this confidence is down to a lot of reading and understanding derived from the incredibly ability to dig deep for information by the knowledgeable people on these boards.
So a big thank you to you all - your input it is very much appreciated.
Thanks Enteleon - was interesting to read the reference to a handshake chip on each consumable. The concept of 'off-label' cassettes was raised as a potential issue by a gentleman who attended the 2019 AGM. He mentioned that he worked for a local company (possibly on campus at Guildford) who were specialists in that field and he was happy to discuss the possibilities to help protect AGL's revenue streams from cassettes.
A side benefit of the handshake technology is the ability of the Parsortix machine to send live data of consumable use back to Angle head office for data purposes/supply logistics.
Although this is a simple technology to incorporate, I clearly recall Andrew Newland appear to be immediately impressed with the idea and asked the Gentleman if they could have a further discussion after the AGM Q&A session.
It seems that this added security will also help reassure during the FDA process too - it really feels as if no stone has been left unturned with the FDA submission.
May I ask how you came across the knowledge that AN has responded to concerns from the FDA's anxiety about 'off-label' as I don't recall seeing this before.
Many thanks.
Many Thanks Diversified - that worked :)
Hi Diversified, is the Telegram Group a private or public group chat - do you need an invitation from someone to join?
I believe the $5B figure was assuming a future NASDAQ listing to be able to achieve that sort of figure.
A reference to Exact Sciences as an example of what could happen to AGL stock price was used.
Exact Sciences came out with a colon cancer test and once FDA approved the stock price went from around $6 or $7 to somewhere around $120 per share. Exact Sciences only have one test that can only do Colon cancer tests.
Exact Sciences current market cap is $12.56 Billon @ todays share price of around $85