Member Info for miavoce

I guess todays news is part of a jigsaw but unclear what the picture is while we can only see this one piece. Hopefully further pieces will will be slotted in soon....

Maybe a case of no smoke without fire, and the appointment of Stifel is the smoke....

Should finish blue....

The lack of posting is probably more to do with there being nothing to post about ...I've not noticed any hostility which would put me off posting if there was anything to comment on.

Hi GF123 - I tend to agree. This may be a step in some sort of corporate activity as 3 platforms plus Covidity is a lot for a very small company to chew.

I suppose it's not impossible that the original text was intended to mean that it is the regulatory submission which is aimed for 1H2021 but it was very badly worded if that is the case. The next text may simply be a revision of the poorly worded text. But I suspect I'm being generous.

CEPI just tweeted the March article again which mentions Scancell.....hopefully they are now putting their money where their tweets are.

https://twitter.com/CEPIvaccines/status/1404076343021670402

Hi researcher1

on advfn I was referring to the fact that Angle will not need to repeat the technical proving on the machine when they apply for approval for the capture of CTCs for other cancers such as prostate or ovarian. This assumes that the machine itself remains the same (a there is no reason to change the machine in order to capture CTCs from another type of cancer).

If in the future Angle introduce a whizzy new version of the machine itself then I expect they would have to get FDA approval for the new machine although I'm not sure what the FDA process for this would entail (although I expect it would be along the 510k lines).

Would be a nice touch for CEPI to announce that they are providing funding for a UK company developing a Universal Vaccine at the same time as the G7 are meeting in the UK.

Hi PJT12

IMO a key underlying factor behind the 3 fold rise was the fact that the SP was driven down to the low 40's by the forced selling of Jupiter as it closed down one of its funds. Without this selling my feeling is that the price would have hovered around 70p prior to the the FDA submission and today's price would therefore only represent an 85% rise from that point. Whilst even this is substantial it far from reflects the value of the market that FDA approval will unlock and hence my expectation of a very substantial rise.

Hi PJT12

not sure you can compare the FDA approval effect between Biogen and Angle for the following reasons:-

1. Biogen already had a 40Bn market cap before etc eFDA approval, so no way was this going to double to treble on approval. Angle on the other hand has a tiny market cap by comparison so could easily multiply on FDA approcval.

2. Biogen is a highly liquid stock with very high daily trading volumes whereas Angle is relatively illiquid. Should Angle get approval the volume of share trades will be many multiples the daily volume average.

3. Angle has relatively few shares in issue and many of those are in sticky hands. The limited availability of free float will quickly drive the price sharply higher as the mm's look for stock.

4. The Parsortix concept is simple and lends itself to great headlines....e.g. 'UK company first in the world to get approval for cancer biopsy using blood draw....'

FDA approval will, IMO lead to 100% + increase.

It wasn't a director buy, it was a person (i.e. Vulpes) closely associated with a director (minor point...). As long as the individual in Vulpes who decided to buy does not have any inside information then they can buy whenever they want.

Snap indeed - I was just about to post the same thing. Let's hope that Modi1 is indeed on track....

Hi gawdhelpus

in my experience prices tend to rise in the lead up to FDA and I wouldn't be surprised to see the same here.

Why do you think there will be no more pharma contracts prior to FDA ? The pharma work is completely unaffected by the FDA outcome.

The FDA will be making their evaluation for as single Parsortix usage i..e MBC CTC capture and harvest, based on the material submitted by Angle. The FDA analysis will not have been muddied by the publications related to other use as these will not be in the submission and will be of no relevance to the FDA.

Hi C7 - you are getting ahead of yourself - we won't be in Q3 / H2 until 01/07.

Good find crumbs. So just over a year ago they had already sorted out the delivery mechanism...

On a happy note - news is now 105 days closer than it was when there was the flurry of press on 15/2.

Correct yuyus - Parsortix can capture CTC's for any solid cancer. To get FDA approval so sell Parsortix as a device that can capture CTC's for a particular cancer Angle has to undertake various controlled trials / studies to prove that Parsortix can indeed capture those CTC's. Once Angle have FDA approval for metastatic breast cancer CTC's they will then move onto the studies for the FDA approval for other cancers. The process for other cancers should be much quicker than the MBC submission as:-

a) they will no longer need to follow the de novo process (the MBC Parsortix approval will act as a predicate so they can follow the 510k submission process)
b) a lot of the studies needed for the de novo approval will not need be needed for subsequent FDA submissions (i..e those analytical studies that are to do with the generic technical capabilities of the device rather than studies specific to a particular cancer)

I suppose what it tells us, if nothing else, is that they were expecting to start trials in Spring so hopefully this means that we are not too far away.

I see it was published on 11th May and the section on the Covid vaccine says 'We’re due to start early-stage clinical trials this spring and hope that we see more positive results'....may be an old quote as some of the text from the article is from a while ago, although Google only brings up the Ambition article when I searched on the quote so maybe Spring is still on the cards....