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What EXACTLY what the wording of the this by "the end of January" pledge anyway. A line from the presentation?
Roger,
It was cleared up way back that this was going to be a De Novo case, as there's no comparable test in US market. In any case, the actual fees charged by FDA are always virtually immaterial. The big money gets spent on the proof they require on US soil.
Roger,
"cost of De Novo and 510k routes are far cheaper"
Post some evidence of this. GDR said it would cost about £2m a couple of years ago, and I can't see much has changed. It will probably cost more than that given inflation.
Stockpick,
They way I view it, news on FDA progress would be tied to a placing. I expect minimum £2m will be needed to finance the beginning of a venture into US market, and to secure FDA approval (not actual fees to FDA, but actual testing the product out on US soil, which FDA pretty much always requires).
Some bureaucracy yes, but it's possible GDR weren't very clever about their strategy. Why did it suddenly end up in a hazy EVA process? And why didn't they just go for specialist commissioning earlier? I suspect didn't bother getting advice from market access/regulatory consultants ahead of time.
God knows. But NICE does have a tendency to rereview the same thing every 3 years.
It's definitely not EVA, but will be extremely surprised if they say NHS should adopt across whole organization straightaway, as it's such a new test. I expect they'll still say they need a lot more extensive data gathering and will launch another review after that.
The new CEO still hasn't bought ANY shares at all after months into the job. That tells you most of what you need to know for now.
RF don't have shed load to sell because they must have already sold all of them, or the vast majority by now. But if there's another £600k drawdown in early Feb, the whole RF selling cycle thing starts again.
But on Quora they say it means: "any month between January and April"
"If no RNS today or tomorrow....imho that's it for January, and we,re in big trouble"
Possibly System. I thought "early next year" on funding to kick off FDA and USA strategy meant early January, but it could mean first half of February, who knows. For me, will be good opportunity to invest, if they secure stable funding.
Maybe I'm naive, but I don't think RF organise a pump. I think though they do take advantage of any volume here by dumping straight into it. They are not a significant holder as they have consistently dumped at regular intervals, so they not obliged to report and issue a TR1 when they sell.
Short-term it's all about getting funding to get FDA as far as I can see. If they don't get necessary funding they will obviously still try to string out current finance arrangement as much as possible. This latter will become very difficult though if share trading volume drops to very low levels seen late last summer.
Professor,
A bit of "bureaucracy" is understandable. It would mean £7m a year in annual revenue for GDR, so quite a big deal, rolling out to all NHS trusts in England. (Not £8.5m as this would be just for England, not UK). Wouldn't be surprised if it happens by the first quarter of next year. In the meantime, GDR have their sights set on USA. Presumably, they are making some presentations to IIs in the City to raise funding for that???
When a consultation opens for specialist commissioning for NHS England the details will appear here. Typical time for the public consultation phase of this appears to be 3 months. But then there's other stages after that as well before final approval can be reached:
https://www.engage.england.nhs.uk/consultation_finder/?_collection=eyJzb3J0X29uIjogImljb25zdWx0YWJsZV9lbmRkYXRlIiwgInNvcnRfb3JkZXIiOiAiYXNjZW5kaW5nIiwgInN0IjogIm9wZW4iLCAiY29sbGVjdGlvbl90aXRsZSI6ICJPcGVuIENvbnN1bHRhdGlvbnMifQ%3D%3D%3Ae9f8d63e4a91f7ef67ac901f57444778a8e8e76123adb992c4beddf221280e07#cs-finder-results-container
Roger,
Just by the fact we don't even know when the public consultation starts. (assuming it does get to that stage). Then there's other stages after that as well to cross.
Https://www.hfma.org.uk/publications/how-it-works-specialised-commissioning-england
Found this guide to specialist commissioning. It would apply to whole of England if adopted in this way. But there is a public consultation phase as well, which presumably means it's in the early stages at the moment with this particular route. So unlikely to be done and dusted this year the way I read that flow chart on page 8:
https://www.hfma.org.uk/system/files/how-it-works---specialised-commissioning.pdf
RF sells at every available opportunity, there's no doubt of that
Difference is new CEO has better chance of getting the previous institutional investors back on board again