Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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That is precisely why getting FDA approval for this de novo submission is the key event for AGL shareholders in the wealth creation process.
Miavoce and Researcher, Thank you both for clearing that up. That is what I thought before the question came into my head.
As you said, it's not worth sweating over, I mean it's not like I'm going to sell any time soon.
Thanks again.
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
Drums, don't fret about it. This first submission is De Novo because it refers to a new device, as well as a specific cancer (MBC). Angle tried a 'broad brush' approach previously, but were advised by the FDA to go away and return with a highly specific submission(s). Once the De Novo is granted, it will mean each cancer type needs to be addressed individually, but Angle can use a streamlined application which is much faster (and much cheaper too - £500K). They will also need the same streamlined process when they want to upgrade the Parsortix machine.
Miavoce, while I totally agree with you on Angles application being solely for one type of cancer as far as the FDA is concerned, this kind of presents me with a dilemma. People talk about the weight of averdence from other research body's regarding Parsortix's many other uses as having an influence on their decision when it comes to this application, which is for MBC only. As this is a denovo application my dilemma is this. Are they looking at it's ability to capture cancer cells in general, in which case the averdence from other cancer research is relevant. Or are are we going to have to submit separate denovo applications for each cancer type. I am unclear as to what the denovo part of the application refers to. I would appreciate your help in solving this catch 22 problem which has been going round in my head for sometime.
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)
mia, the significance of these Reach RNS statements surrounding peer review research is that it adds to the weight of the case for FDA approval which is the big announcement we all await
Agree and worth noting that Angle release all of these research updates as RNS Reach.
I agree Mia,
Research notes and studies may move the SP in the first instance but having 10x that number certainly should not lead to SP x10.
I think we have an embarrassment of riches in terms of peer reviewed studies and that gives me conviction that my money is in the right place.
Clearly there are things that can effect the SP such as heavy buying etc but those of very short term phenomena. I guess what is driving that kind of buying is a more interesting question.
Great news won’t be long now!
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.
I agree that SP response is underwhelming, but don't blame AN please!
Two stunning RNS so far this week and wham bam thank you mam plus 1p
I rest my case your honour