GreenRoc Accelerates their World Class Project to Production as Early as 2028. Watch the full video here.
Hi Boonco - not only did AGL fall on the same day as the POLX news but the AGL price fell sharply very soon after the POLX RNS was released in the afternoon - more then a mere coincidence I suspect....
Drums, as noted by researcher1 this de novo submission relates purely to getting approval for the capture and harvest of CTC's from the blood of patients with Metastatic Breast Cancer.
Angle will need to obtain separate approvals for other cancer types however this will be more straightforward than the de novo submission for several reasons:-
a) a lot of the technical aspects (ie related to the behaviour of the device rather than related to the specific cancer) won't need to be repeated - the submissions for further cancer types will only need to focus on demonstrating the capability to capture and harvest the CTC's
b) the initial approval will act as a predicate for subsequent submissions and therefore the 510k route can be followed rather than the de novo route which should simplify the approval process
c) the whole process of preparing for and obtaining approval will be a lot cheaper and hopefully a lot quicker
d) submissions for multiple cancer types could be done in parallel
Hi AquaeSulis01
these Reach RNS's will make no difference to the FDA approval as they are not part of the evidence set submitted by Angle to the FDA to demonstrate the capability to capture and harvest CTC's from the blood of patients with metastatic breast cancer (this is the what the FDA will be approving)
I think the market is becoming immune to these research related RNS's which point towards potential future revenue rather than immediate revenue (although in the case of the PD-L1 RNS revenue may come fairly quickly via our lab service). Still, each of these RNS's adds to the shaping of the medium / long term revenue picture which in turn would support a high take out price were Angle to be taken over by one of the majors.
Hi hickorydicorydoc
on the 16th of April, when the closing price was 98p, you posted that you were in a 'large plus position' and that you 'don't top slice or cut and run' and that you were 'here for the end game', and exhorted us to 'Keep the faith'. Your original post is copied below for your reference. Given that you must now be in substantially more profit than your were then (having not top sliced or cut and run), and that you are here for the end game, why the recent spew of posts attacking the company and its management - seems a very strange strategy for a committed holder such as yourself ?
Hi
I’m still here and Will be to the bitter or fruitful end am currently in large plus position but this has happened on many occasions over many years as my good friend Miss BMW will testify
I don’t top slice or cut and run I’m here for the end game
Keep the faith and keep safe
Good luck all
Hi ElderlyBird,
the time to approach the MHRA will be when we have a validated test that can be shown to deliver patient benefit. The first one of these is likely to be the Ovarian Triage test which should be validated by the end of this year. I'm not sure how the process works but I guess in principle a case would then be presented to the MHRA to make the test available as standard prior to surgery for women with a pelvic mass.
In my dream last night Lindy was in my house (don't know why). She was diabetic and needed to eat - she wanted a custard tart so we headed out to the local co-op. Try as I might I could not find the co-op (despite it being round the corner from me) and Lindy ended up buying a very large piece of meat and potato pie from a street vendor (which she said she preferred to a custard tart anyway).
I'm struggling to put a sensible interpretation on this but you are welcome to have a go if you can divine the meaning.
Hi ElderlyBird
Buzz_Lightyear has explained why this device will be good for pharma but irrespective of that could you share some examples to support your assertion that:-
'the FDA and MHRA do not have a good record at making decisions on new systems that will cut down on drugs'
You have basically said the same thing in each of your 4 posts over the last 2 years but haven't provided any supporting evidence for FDA or MHRA - I'd be interested to see the examples.
Thanks
Hi jakeyork
as you might know the Parsortix system enables the capture and harvesting of live cancer cells from blood whereas Grail (and other ctDNA based systems) simply detect DNA from dead cancer cells. The live cells enable clinicians to understand much more about the cancer (RNA, protein expression)which informs decisions about treatment in a way that DNA alone simply cannot.
The future for Parsortix is very bright indeed and isn't threatened by Grail or its peers - as has been stated before they are complementary.
Once Parsortix has FDA approval the brakes will be off on much wider pharma use of the system, partnerships with the like of Abbott, further lab contracts, and (IMO) a takeover in the not too distant future.
I see from your earlier posts that you have bought, sold, increased, reduced etc etc over the last few months. If you understand the investment case for Angle them surely you should just buy and hold rather than being influenced by the daily gyrations of the share price. If you don't understand the investment case then probably better to invest elsewhere for the sake of your nerves ;-)
To clarify, Andrew N has made the point that the same blood sample can be used for both CTC capture and ctDNA capture. Parsortix is used to capture the CTC's and then the residual blood can be used to do ctDNA analysis using a system such as Grail.