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Possibly because it would cause a huge spike and the US partner might prefer to see how all the trials go with a view to making an offer? It’s extremely odd why it has to be kept secret. Doesn’t do GDR CEO’s reputation for being open and honest any good that’s for sure.

No Guy. The US medical partner - who still hasn’t been named - was brought on board because they could assist with implementing clinical tests across the US. I assume they haven’t signed a deal to take a % of future sales or we should have been told about it. So, imo, I think GDR will be paying not just for the tests and machines that will be needed but also the partner for organising the clinical trials. That’s why the monthly spend will increase in early 2025 to add much as £600k. All of that info will be fed into the FDA application.

Unlike Em Carrots I’m expecting/hoping for FDA approval for MT-RNR1 early in 2025. Not tomorrow.

If these assessments give a green light there will be an almighty spike. Any nod for a national rollout in Scotland or England will trigger serious interest from pharmas

FDA submissions and data gathering with the US partner in clinical trials I think Guy....

Think this would be great for companies like GDR. Getting into the main market would attract far wider interest. Even if a tiny tiny % of the funds available in minnows such as GDR would have a huge impact on mcaps.

https://www.ft.com/content/51f5632a-b28e-4d46-9064-32944809dead

I'm back in fairly heavily with an average of 2.18p. Happy to hold for 3 or 4p by end of October. Can only trade it though as the company Directors don't know how to run the company as an investment entity. they will undoubtedly f.ck something up again soon once there has been some news. Most likely though they will just say nothing as they seem perfectly ok with the sp being sustained in the mire

I'm in at the moment JLC. Wish I could say hand on heart I knew exactly what is going on in this company but I don't think anyone knows, not even the Directors? I think there's a potentially very big rise coming soon. Any whiff of a national roll out in Scotland even if not until 2026 will surely give the chart a big blip

Onlyprofit - I think this could easily hit over 3p as we head to the end of this month. A little patience for a possible 20% uplift not too much to cope with is it?

Why? We are due the findings of two impact assessments for the NHSS by the end of this month. I'd say there's a decent chance of another good rise as we approach that, followed of course by the usual GDR period of silence from the company and another drop of about 50% over the following two or three months as we await the next news. Results could be interesting!

Doesn't bode too well for GDR which is due so much great news. Where did that huge rise up to 2.85p come from last week? And more to the point, where has that sudden burst of sentiment disappeared to now?

Pretty certain this one is going under.

Yeah, as I said, it's not absolutely crystal clear the process is now underway. Not for me at least. Hope it is but I don't think I'd be shouting out to anyone that FDA approval is due as of any day after tomorrow....

I am keen to see the outcome of these NHSS assessments at the end of this month. If they are positive then I wonder how long after that they can actually get the 30month data collecting phase started. The document states they have to collect at least 10,000 - 20,000 test results within a 30 month period. Therefore, if the whole testing period could be started by the start of 2025 we could be looking at a proper Scottish nationwide rollout by some time early 2026 given the high number of stroke and cardiac arrest victims they have.

Listening on BBC R4 this morning Kier Starmer is keen to remove red tape for new technology - I assume this includes in the medical sector - and thus attract investment from abroad. All sounds great but of course what they don't say is that they will then raise CGT on all profits made so it's a case of snakes and ladders. I agree with those posters who think GDR will end up being taken over. Big question is when. Will it happen once sales are starting to take hold or before, when the sp and mcap are still relatively low for a company with a huge potential market.

Gilham won't sell this venture for hundreds of millions - unlike his previous projects - but I think he'll still be looking to sell at some point soon.

It’s the FDA De Novo process for MT-RNR1 we’re talking about. I’d be interested to get email confirmation from the company if anyone can be bothered but as I say, I have a feeling they haven’t even started it yet Em Carrots.

CYP2C19 FDA application should start in 2026/2027 and by which time the hope was the AIHL gene test would have gained approval by the start of 2027.

I could be getting confused though so happy to accept I could be wrong…

EmC are you sure that the process was started at that time though…? It’s not clear that receiving that designated status is actually the beginning of the approval process but rather could it be they’ve just confirmed which route it needs to go down? Not playing devil’s advocate, just trying to see where things are clearly with FDA. GDR’s comms are always poor and perhaps deliberately so but somewhere in the back of my mind I thought I’d read GDR for some reason have not yet hit the Start button on this with FDA…or was that CYP2C19 test?

GG123 - there isn’t £6m in the bank any more. Monthly spend of £400k (due to increase early 2025 to £600k to pay for FDA application) and they raised the £6m in May. More like £4m left.

Only one test is fully approved by NICE. MT-RNR1 is still in ‘conditional’ approval phase, awaiting results of data collection I think. It is hoped the approval for this will be upgraded to FULL recommendation before the end of this year or early next.

Just for balance, there seems to be a lot of good news that could land very soon so the mcap of £14m is largely based on sentiment rather than fundamentals - with an annual income of about £250k from sales (and that’s before costs are taken into account) £14m is a crazy mcap - and the landscape financially for GDR cd change in a heart beats with one good RNS

Laura, you’re talking bs. I did not claim they needed cash in the summer after they’d just scraped together £6m. I said they will need cash by Easter 2025.

Oh and where did the £1m revenue come from? Can you pleas tell us which set of accounts that came from? They are loss making to the tune of a few £m each year at the moment and have sales of approx £250k and a tax refund of about £800k to put in the + column. A tax refund isn’t revenue so I’m keen to know where GDR at earning another £750k a year from. Great news if you can prove that. Thanks

But are they all new recruits for new positions ie expanding the workforce? Or have 5 people left in the last two months?

It does look as though things are stirring for GDR but this latest delay is just typical of UK bureaucracy slowing up progress. Anyway, not long to wait to see what these assessments will tell us. Of course GDR will only start making money once they are selling products and that can still be a long way off. I can’t believe after all the trials they’ve already done that it will be another 30 months max before there would actually be a roll out in Scotland. Hopefully it can be achieved much sooner than that.

Love it poshify. Tks

See ya next week for more of the same and the continued decline.

These assessments seem to be popping up everywhere! Still not sales but progress in some degree.

Buying suddenly taken off again and mms happy to up the Bid by loads to get their hands on shares.

What are they playing at? Either it's just fits and giggles for them or there is an RNS logged. Late on a Friday afternoon not usually a good time though to release news...hold tight