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What's important about the news is the high capture rate in the study for prostate cancer (94%) or 16 out of 17.
A high capture rate is pivotal to commercialization. If the capture rate was low then it would make this harder. But it looks like prostate cancer capture rates will be very very high just like in ovarian cancer.
With the partnership and study with Solaris for prostate cancer to come this is very positive and could be a massive fast track towards commercialization.
Even without FDA clearance for prostate cancer (which they could get quite quickly too) urologists in the USA that work Solaris and MidLantic urology are highly likely to want their clients to have a liquid biopsy with parsortix rather than the current method of prostate biopsy if capture rates are very high.
Yes Zebbo and if you invested about 18 months ago your investment would be worth 3 times what it is worth now.
I'm quiet happy with Angle building a business as it means a higher SP.
Now if you were a trader it was not what you wanted to hear .
It's not what traders want to hear Jin
Again the IP here supported by the IP angle has.
If a company was to buy Angle it would be for substantially more than the current MCap.
Do you expect AN to come out and say ' ya we are for sale, please buy us'.
No one who even wanted to sell something would come out and say it. That is obvious.
I think the reason for the underwhelming SP currently is due largely to current market conditions.
Atm the entire world is collectively crapping its pants about a massive financial crash.
We have seen the SP of bigger liquid biopsy companies in America fall a lot over the last year (Guardant and exact science) . The NASDAQ and a lot American Medtech stocks had very high valuations i think based on potential future value.
I would say AGL was quiet possibly overpriced one year ago when it hit 144p before FDA. However i feel the current share price now is very good value . The IP of parsortix is worth more to a big pharma company than the current market cap right now. As many have said its been derisked since FDA .
Commercialization will take time because this is disruptive technology and is creating a new market. It is changing cancer diagnostics and how we monitor and treat cancer. That is not going to happen over night. But the liquid biopsy market is huge and AGL have a very specific niche. Once it starts gaining recognition among clinicians it will likely take off very quickly once they see its use.
I can understand sellers fearful of the state of the market currently, its looking quiet bleak. If you are a trader that is what you would look to do.
But as an investor things look very positive right now if we focus on the company.
We shoulder have ovarian trial news soon too, lots to look forward too.
Hi scot, on last count there was only 3 fda submissions left from 2020 max. It may even be less.
And it seems the longer the wait the higher the percentage change they are positive. The last few have been positive.
Added to that AN's comments about this being in the administrative phase and the recent FDA approvals it is thought FDA approval could now be very very close and the odds are heavily in favor of it being positive based on recent trends.
Im loving this RNS. I can imagine pharma companies will really want to be using parsortix now to test the effectiveness of their cancer treatments and how it matches up with with PD-L1 patients.
These treatments are expensive and the low success rate could be greatly improved by parsortix.
This could give any pharma company in this field a huge advantage over the competition when their drugs success rate is suddenly multiples of other companies based on patient selection
I think what bojo is trying to say is the NHS is risk adverse and slow to adopt new technology .
I think it will take FDA approval, then Abbott successfully using parsortix and reducing the need for biopsys and choosing the right cancer treatment based on results before the NHS deep their toes in. The fact parsortix would save them money would speed up this process.
Grail have very powerful backers and a massive pr machine which is why i think they already are working with the NHS. But imo it may be too much too soon for them.
122p now. Again Friday tends to have more FDA approvals so there is high anticipation today.
Seller seems to get out of the way and FOMO is kicking in
It will.probably slowly inch towards 140p in the next 2-3 weeks. But if FDA happens it will blow past 140p
Im in for 5 figures, average is 98p
Right now crisp. If i was you I'd sit tight for FDA approval, if positive then I'd buy.
Of course your not going to get no where near as good a price as today but after FDA it will be completely de risked and the sp should eventually rise to many multiples of today.
That'd what I'd do from a responsible investor position.
But personally I'm very confident of FDA approval, I'd definitely put more in at these low prices now but from a safe investment perspective waiting until after fda approval would be the best option now
David. The big driver of SP right now is FDA.
THe company submitted an AIR (Additional information request) on the 4th of June. It has now been 75 days and FDA decision is expected anytime from this week until the end of September. The the pull back is likely due to people taking some money out ahead of FDA decision to de risk a bit , although Trinity estimated that chances of FDA approval at 85% and i think that was before AIR so its probabaly higher than that. Newland has said himself that FDA is a matter of when rather than if and they have put massive work into this with the FDA over the last 5-6 years to make it happen.
There have been some lab contracts signed already but it is expected after FDA that there will be lots more.
The FDA approval is linked to Abbotts HER FISH test and will allow Abbott to charge i think between 2000-3000 dollars more per test. It is expected that a deal is already lined up with Abbott for after FDA approval which will be huge.
They are also expecting futher ovarian cancer test results in Q4. Previous tests showed a 95%+ accuracy in diagnosing if a pelvic mass is cancerous or not.
It is also expected to list on the NASDAQ later in the year.
While the SP drop recently in the short term is annoying, it wont last for long
Dibs, trinity had 220p as the target price before FDA. I think Finncap was 170p
They expect it to be more after that. We are now lower now than after the latest commercial contract was announced ,im not sure how much is already priced in right now
FDA target is to reply to new submissions in 150 days.
The initial submission was the 28th of September and we got the RNS about the AIR on the 4th of March. 157 days.
clock stopped.
We received notice of submission of AIR on the 4th of June. It is exactly 60 days since then.
I can't remember which company but someone did a table on it before and AIR responses seemed to be between 60-80 days. If there are no covid delays we should hear something this month.
https://www.fda.gov/medical-devices/recently-approved-devices/2020-device-approvals
In 2020 60 devices were approved
https://www.fda.gov/medical-devices/recently-approved-devices/2021-device-approvals
so far in 2021 almost 7 full months in 19 devices have been approved. If it continued at this pace we would likely see 32-33 approved in 2021
https://www.fda.gov/medical-devices/recently-approved-devices/2019-device-approvals
46 were approved in 2019.
It seems they are definitely less being approved possibly due to the focus on covid or maybe due to delays.
Either way they tend to approve minimum 1 a month and there still hasn't been one for July.
Agreed, a lot here including myself are more than happy to sit tight.
Trinity gave FDA a 80% chance of approval and that was before AIR i believe which is further de risking. AN also saying he believes its more a matter of time than if they get FDA.
With them kind of odds im more than happy to sit tight and take the what i believe to be a small risk.
Right now is a great buying opportunity