Ben Richardson, CEO at SulNOx, confident they can cost-effectively decarbonise commercial shipping. Watch the video here.
Widglide
Do you know who Robert Califf is?
He is the new FDA Commissioner, who replaced Janet Wood****. He has a personal interest in the accelerated approvals process. It is personal due to his own mother having cancer and having access to multiple accelerated treatment that have extended her life.
The FDA's oncology chief Richard Pazdur unveiled "PROJECT FORERUNNER" an effort launching later this year to expand accelerated approval into cancer treatment.
Can you just imagine his reaction if CIZ could have gone to him with a test that could have detected his mother's cancer earlier?
There is a lot going off behind the scenes that 99.99% of people don't even know/hear of, so to say that the BOD is doing nothing to promote this company is simply not true. How else do you think we get the licencing agreements we have ?
I've said it before, this type of company does not advertise in your local rag.
Neil
NathanR999
Absolutely not looking for an argument, just posting as i believe.
I will substantiate my previous post with the following caveat:
The timescales depend on the route we take.
For example for FDA clearance, we would probably be looking at 510(k) for a class 2 device on the basis of a predicate.
i.e. where we can demonstrate that our product demonstrates "substantive equivalence"
This effectively means that where a similar product has been cleared, if we can show that ours is as good as or better, then we would be granted clearance.
There are a number of "predicates" which we could relay on, on the FDA database that is updated at the beginning of every month.
Another route could be the "breakthrough devices program"
The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.
Both scenarios are significantly less than 2 years. (on the assumption of course, that we qualify)
Neil
NathanR999
We are not seeking FDA appoval.
We are going for FDA CLEARANCE which is an entirely different thing, so timescales aren't what you think. Also with NHS, i expect this to be a lot sooner than 2 years.
NHS is currently up **** creek regarding the number of patients waiting for diagnosis/treatment etc, (in the region of 6.5 million appointments i believe) so you can be sure that they will be looking at any option that will have an effect on those waiting times. Particularly as is the case with CIZ, being a very early detector, thus immediately ruling out a very significant number of potential patients that would otherwise use up a lot of appointments and resources by unnecessarily going through the cancer care program.
I read on a previous post about whether our test works.
We know that it does work. It has already been proved in laboratory tests. The process it is now going through is for repeatable commercial throughput in a hospital environment.
Neil
Widglide
Just to be clear, my only issue was the speed of the flip, and the possibility of them repeating this, not with what the BOD implemented. This asset may well turn out to be a very astute decision.
The problem with the share price as i see it, (apart from the sells) is that the markets simply do not have any way to price us. We have had lots of good news re POTENTIAL revenue streams, agreements, etc, but what the market needs to see is concrete news on actual revenues and results. Then, i believe, we will finally get a realistic valuation.
It's a bit like me telling you everything is going to be great. But you want to SEE with your own eyes that it is.
As for who is buying up the shares, well i can tell you that i for one, been , and continue to do so. I am still convinced that this will produce results. But do NOT rely on my opinions.
Neil
counting cards
Pretty much agree with everything you posted there.
Whilst i can understand what they did, and why, i am not happy with the speed in which the flipped their holding.
Again, i can see the logic behind CIZ buying into the economic interest, which effectively cost the company zero in terms of capital expenditure, BUT ..... personally i will not support a vote on the approval of the remaining 22million shares. My view on this is that i don't know, as you say, if they will offload again. By not approving the vote, this will in effect force them to hold for circa 10 months. That is 10 months in which i want to see a return on the investment made in the AZD asset. If no return in this time, then it's time to rethink what if any, the benefit to us was, or will be.
Neil
Rooblertwo
To the best of my knowledge, i have never posted a personal comment about anyone.
However, in your case i will make an exception.
You really are the scum of the earth aren't you?
Since you made such a profit on your other stuff (don't believe it looking at where else you are "invested", ) will you now honour our bet to donate to terminally ill children?
I donated 20 times what your amount was even though i won the bet, and proved it.
Katstrangler,
Thank you for your good wishes, but just to correct a couple of points...
I am not wobbled. I own a substantial amount of shares in EUA, and nobody's opinion on here will have any effect on me.
I have not sold a single share.
"Holding and hoping" is certainly not my policy. I invest based on the fundamentals of the company, and a LOT of research.
You are incorrect in your statement that people here aren't 200k buyers / sellers.
My post wasn't aimed at anyone who gives a reasoned opinion, but at those that just come here to give it "2p next week"
I wish all genuine holders only the best.
Neil
To those who come here trying to spread fear and panic -
Just take a moment to consider your actions and then compare them to the 13 border troops defending Snake Island. (report to be verified, but plenty of links)
When confronted by a Russian warship that "advised" them to lay down their arms and surrender, their reply, in the face of what they surely knew what was coming, was "Russian warship......go fcuk yourselves" seconds later, they were all dead.
Your behaviour is shameful. These were real men, not like you trolls.
In a separate development, which i hope is true, the hacking group Anonymous, have apparently hacked Russia.
Russian TV channels appear to have been hacked to broadcast Ukrainian songs, according to reports.
All of the Russia's government webpages are also down including the official website of the Kremlin - the office of Russian President Vladimir Putin - kremlin.ru, following reports of cyberattacks on various other state media websites.
In a chilling video message posted online by the hacker collective called Anonymous, a member of the masked group speaks directly to Putin.
they call on him to resign and restore the rights of the Ukrainian people.
The message, read out in English, with Russian subtitles reads: "Greetings Russian President Vladimir Putin.
"We have been patently waiting for you to respond to our most recent request, but we find ourselves growing impatient of your foot dragging.
"Unfortunately it seems you have made the option to ignore our presence and therefore we have decided to dedicate and operation specifically for you.
"A present of sorts."
He then goes on to name other times the group has taken websites offline.
He adds: "Your recent attempt to threaten Finland and Sweden is shameful.
"You threaten to invade those countries if they join NATO.
Anonymous also tweeted: " #Anonymous is at war with Russia.
Neil
Countingcards,
I don't know where you are seeing those timestamps, but the official trades as listed by London Stock Exchange is as below with publication venue being ECHO, and tie up with the times shown here on LSE
Note, just the 2 trades shown
2022-02-24T15:14:10.110 GBX 2.6 76923 1999.998 Off-Book XLON P XLON
2022-02-24T12:45:00.000 GBX 2.6 6300000 163800 Off-Book XOFF P ECHO
2022-02-24T15:10:15.457 GBX 2.584 100000 2584 Off-Book XLON P XLON
2022-02-24T15:10:14.313 GBX 2.584 250000 6460 Off-Book XLON P XLON
2022-02-24T15:10:11.267 GBX 2.584 10000 2584 Off-Book XLON P XLON
2022-02-24T15:09:06.310 GBX 2.584 20000 516.8 Off-Book XLON P XLON
Neil
Generally, when you see 2 trades followed by a -ve trade, it is indicative of a short position opening / closing.
The key is the time stamp. If you look, two of them were exactly the same time stamp, but unusually, the third was different. Could just have been notified late.
Neil
Just one bit of info i thought i would share....
I know a couple of posters queried the other test that the NHS is evaluating. I pointed this to being the Galleri test.
I am aware that the NHS trial is just one of a number of trials that Grail have enacted.( they are doing these to get the same approvals we are chasing)
From the data received, i can tell you that our test absolutely knocks spots of theirs.
As an example, one study has shown that Galleri only detected 39% of stage 1 cancers.
In another, false positive tests came back at 49%
To put it another way, you would have more accuracy if you called heads or tails on a coin toss!
Lots of literature is out there saying " can detect 50 cancers, high accuracy, specific targetting" etc, etc. When you look at specific data, it suddenly doesn't look quite as good as the headline would imply.
Getting into NHS first and foremost will be the overriding priority. We already have the proof of concept proven in laboratory tests on a prototype using a polyclonal antibody. We are now modifying the test for monoclonal antibody, so we can demonstrate repeatability, and a high throughput / low base cost for commercial use in hospital environment.
Neil
Hi Widglide
Glad to see you are a bit more positive and hope it works out for you. ( I am sure it will, you know my stance on this ) More news is yet to come on a number of fronts.
I am wondering if we will fastrack our kit into NHS by way of a slight deviation on the CE marking process. To get it in quicker, we could go down the route of UKCA which is the new regulatory body for UK only market following Brexit. (The CE mark doesn't actually lapse yet, as it has been extended due to Covid impacting on the full application of MDR regulations)
It would get us there quicker. As we are looking at our test kit being registered as a Form B device, this will also mean that the requirements for verification aren't as onerous as other devices. Then we can carry on with CE mark for Europe, and FDA for USA.
We are looking at utilising the submission of retrospective testing data for CE approval, and FDA clearance. Again, if accepted, this would give a quicker path to approvals.
It's all coming.
Neil
Schlum/Islandgirl,
The test you are referring to is the Galleri test.
It is being evaluated by the NHS, BUT it is not the same as our test, so no real comparison. Galleri is specifically aimed at already "at high risk" individuals, specifically in the 50 - 77 year age range. It does not have FDA clearance, nor is it CE approved. It is being trialled on a Clia basis. Our test is being developed to detect cancer at a much earlier stage, and not restricted to known, at risk groups, or specific age groups. We discussed this previously when it was announced. If you look back at some posts i made in September they give more detail.
Neil
There's no "maybe" about it RiseOfThePorper,
Our focus is initially getting our test kit into NHS.
A further development later, will be to make an adjustment to the test in order that it can be rolled out to Primary Health Care providers, with the goal being that it can be used by your GP.
Neil
mcadder,
"unfortunately was a sell"
yes, but.....I have been looking at the trades today.
I initially thought that the 15.5 million may have been just been bought up by general trades.
The trade was time stamped at 11:39:28.577 on X LON
However, there is a corresponding trade, 28 seconds later which was time stamped at 11:39:56.217, but this one was on ECHO.
I may be wrong, but i think that was a straight buy/sell between 2 parties.
We should know either way on Tue/Wed next week, but even if it was just a sell, it had very little effect on the share price.
Neil
Hope you follow this chain of events......
Enterprise Ventures were aquired by Mercia Asset Management.
Mercia Asset Management were previously known as Finance Yorkshire.
Part of Finance Yorkshire's fund portfolio was a sector known as Finance Yorkshire Seedcorn Fund.
Yorkshire Seedcorn Fund were the providers of the initial capital (and later a small unsecured loan £10k) back in the days of York University when the company first registered.
All that has happened is that they have sold off 15.5 million shares, and still hold 7,437,410 bringing them below the 3% threshold for reporting.
They sell off assest in this way quite regularly - there is nothing untoward about it, it's how they generate their investment funds. You can be sure that they have made a tidy profit, even selling when they did.
Neil
Not IF it gets approved in my opinion, but WHEN it gets approved. And not next year either. I am expecting an RNS detailing approval in the very near future.
No need for a raise either. We are fully funded until end of 2022, and the recent agreement means further income for us. There are still other interests that we have that could provide even more revenue streams.
Any further funding required, would be for other projects in the pipeline, which we would be looking at towards the end of the year.
Neil
Great RNS, Posted previously about the expected agreement with China, given Allan Symm's previous dealings with them.Still more to come in my opinion, with companion diagnostics, licensing agreements, etcBut the real turning point will be the RNS that tells us about CE and / or 501(k) approval.Neil