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Nice!
Bantham.
So that says - full approval in the US for Breast cancer. No restrictions. Good.
And it says use for all other cancers restricted to drug trials.
Is that correct?
----------------------------------------------------
I believe that is correct. Just the Breast cancer side alone could swamp Angle Plc.
Basically the potential size of the market is quite incredible.
miavoce and TwoGood2Die were arguing over additional potential market from other services labs.
miavoce posted this:-
"Wrong TGTD. CLIA labs do not need FDA approval to use parsortix for testing any cancer types. As long as the labs have validated the tests that they are offering then there is nothing stopping them from offering the test. This is why Angle are developing the Ovarian and Prostate tests (clearly there would be no point them doing this if lack of FDA approval would prevent the tests being carried out by labs).".
I think other Pharma Services Co's who have the CLIA accreditation can offer tests on circulating tumour cells that ***happened to have been obtained*** using the Parsortix machine ***"as long as the labs have validated the tests that they are offering"*** as miavoce said. So I believe there is additional market here too.
All IMHO.
Ok thanks EC.
So that says - full approval in the US for Breast cancer. No restrictions. Good.
And it says use for all other cancers restricted to drug trials.
Is that correct?
Isn’t that what TG2D has been saying or am i missing something?
Therefore is can be used anywhere in the USA to catch Circulating Tumour Cells (CTC's) from people who have metastasized Breast Cancer. Also as American FDA approval is the "gold standard" most other countries will approve it's use too. These CTC's can then be tested to find out for example the cancers current HER2 status, before (if necessary) , during and after treatment. As we know a cancers HER2 status can change over time. The point here is that some modern drugs can target cancers that are HER2 positive (they lock on and deliver poison to the cell). So a tissue biopsy from the original surgically removed lump might be HER2 positive. Then the person may well be given a treatment that targets HER2 cancer cells. All well and good. If however the cancer changes to HER2 negative during treatment then the drug that targets HER2 won't lock on and so the drug won't work. If the change to HER2 negative is known then the treatment can of course be changed. The breast cancer market alone is enormous.
Then there is the massive World wide drug trials market. Parsortix can be used in this scenario for any cancer, not just Breast. In the following video it says Eisai Inc. (top 100 Co. in Japan) have 80 active cancer trials with 60,000 participants. That is just one Japanese Company.............. See 14 mins 45 secs in to this video:-
https://www.youtube.com/watch?v=cnQ6M05BiBY
https://www.youtube.com/watch?v=ZqaWMUx7GhE
All IMHO.
Thanks EC. Could you give us a time during the presentation that he gives a precise answer to the question some of us are struggling with please?
Bantham.
Have a look for your answers here:-
https://www.youtube.com/watch?v=cnQ6M05BiBY
When are they due?
TG2D - now you mention it i remember that. Word soup. Absolutely he was vague. I wonder why.
Miavoce - the question is what specific statements can you source direct from Angle that supports your view? I think you might struggle.
I absolutely don’t know the answer to this question of what precisely Parsortix can be used for ATM - but given the history of this company that certainly raises a question or two.
The time says 09:38:16. Could be earlier today or another day.
No way to tell if was buy or sell.
Would have more than to date. I strongly suspect Mr Newland want's "top dollar" for any deal. This is based on the Parsortix machine being probably the best way to catch a circulating cancer cell for assay tests etc. Also as I understand it 99% of the captured cells are alive and intact, you could hardly get a better sample to test. Also Angle are a relatively small Company so could easily get overwhelmed with orders (perish the thought!). One of the good things about the Bioview contract is obviously both Bioview and Angle want to find a big partner so both sales teams will be busy and Mr Newland will be closely working with the directors of Bioview on any deal.
You only have to look at the last few Astrazeneca annoucements to see the industry desperately needs a way to find our if a cancer is HER2 positive, HER2 low, or HER2 negative before, during and after treatment. At the moment after the initial biopsy it's anyone's guess whether a cancer will remain HER2 positive during treatment. If not, as I understand it, the treatment simply won't work and no-one would know for weeks/months.
All IMHO.
Newland’s “hype & hope” strategy is wearing thin.
Bantham
At January's Investor Meet Newland was playing with words deliberately being vague..what he said is that outside of breast cancer testing, my understanding, labs could use Parsortix to test for other cancers so long as they sort accreditation from the FDA, otherwise Parsortix could only be used for research purposes only. Hence how many lab are going to spend considerable time and cost to gain accreditation for a suppliers machine, answer few if any!
It was a truelly ridiculous statement made by Newland deliberately designed to pull the wool over investors eyes!
This explains why no commercial deals of note to date and highlights how Newland deliberately misleads and misguides investors.
We definitely need some substantive news around commercial progress. Without that then the concerns might not be around the fundraise, but the lack of being able to get one away. I’d imagine the market will want some concrete evidence of commercial progress, details of which are worryingly vague in my opinion. All feels a race against time.
Hi Miavoce
Commercially - i agree. Shareholders do not need to understand in order for Newland to close some deals.
But it’s a point of basic communication. Why not make it totally clear to your shareholders? I mean if it is as you think, allowing this confusion is just id1otic when you would think you need a strong share price for an equity issue in due course.
And the fact that Newland hasn’t closed any significant deals ( yes i do know about the $250k Eisai ) raises questions doesn’t it ?
Hi Bantham
I expect that CLIA labs are not confused and know exactly what they can and can't do. This is all that matters (not the confusion cased by disinformation spread by ill intentioned posters).
The fact that this confusion exits is symptomatic of the failures of communication of this company.
It should be crystal clear from Angle’s communications exactly what can and cannot be done today and what that means commercially. It should be very simple to spell this out.
I admit to being confused on this point.
It’s very basic and very important.
Wrong TGTD. CLIA labs do not need FDA approval to use parsortix for testing any cancer types. As long as the labs have validated the tests that they are offering then there is nothing stopping them from offering the test. This is why Angle are developing the Ovarian and Prostate tests (clearly there would be no point them doing this if lack of FDA approval would prevent the tests being carried out by labs).
Miovace
There is a distinction between a clinically approved lab and one that has accreditation to use the Parsortix machine for testing cancers other than breast cancer which requires FDA approval for Parsortix to be used to 'test' and diagnose other cancers and provide guidance on drug treatment.
Think you are getting confused between a clinically approved lab and the Parsortix machine being FDA approved for testing usage regarding wider cancers.
Here you go TGTD - approx 320,000 CLIA approved labs in the US. In due course, once they are fully developed by AGL, the subset of these labs that are commercial labs could provide the Prostate and Ovarian tests using parsotix.
https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments#:~:text=In%20total%2C%20CLIA%20covers%20approximately,for%20implementing%20the%20CLIA%20Program.
Miavoce
And exactly how many labs are clinically approved to use Parsortix to test cancers other than breast cancer?
Let that sink in because you don't know do you..let me help you....ZERO!
Let that sink in let's deal with 'facts' not what you think actual facts, a link showing the number of clinically approved USA labs that can use Parsortix for testing cancers other than forcbresr cancer.
You get very easily confused between using Parsortix for research purposes only versus live testing for cancer diagnosis...
You've been told this a hundred times now you have no facts!
That is my understanding miavoce and the reason for my question a couple of days ago.
Parsortix harvests the cells and then a downstream assay determines the HER2 status - sequential processes. The laboratory accreditation should supply the validation necessary to apply results to determine the treatment regime.
However, as another posted MBC is probably the most prolific form of cancer so, sadly, no shortage of patients.
Parsortix may also have a role to play with solid biopsy samples - I remember an RNS a number of years ago where a research department was having success with a process whereby solid samples were, I think the term was dissociated,(think blender or smoothie maker!) and the resultant slurry was then run through a Parsortix cassette, apparently with great success. This had the potential to short circuit the normal process of preparing and examining a number of microscope slides to detect CTCs using fallible human eyes.
Let's hope that Parsortix can play a vital role in what could be a game changer with AZNs new treatment.
All IMHO
That
?????????????
Dare I mention.
This clip reminds me of the message board here. I’m not sure who is play which role but jesus there’s some weirdos knocking about just posting the same drivel hour after hour!
https://m.youtube.com/watch?v=1nSYZVsHnVU&pp=ygUSc2NvdHRpc2ggcHViIHNjZW5l