The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Good summary Eureka01, just to add if /when we get full approval for the stroke test this could make a huge difference to the roll out world wide as NICE carries a lot of credence and would speed up any use for other health care around the world.
Apologies. That should read potential world market £100 million. The UK market is indeed assessed at £8.5 million.
All good Eureka but I thought the potential market in the UK was £8m?
Time to look at the upside and downside of GDR at present.
Positives
AIHL
1)The company now has a research partner, a leading multi state physician group within the USA "to support clinical studies required for engagement with the FDA to progress the regulatory approval of the Genedrive MT-RNR1 ID Kit into the USA." In the interims we were told that this organization has "broad coverage of neonatal intensive care units nationally". So ideally placed.
2)GDR also has a distributor agreement with International Biomedical Ltd "to support the FDA study and future sales in the United States ". So a 2 pronged approach to progress to approval in the US.
3)Can be used in the NHS with the NICE conditional recommendation.
4)New sites already announced in the IMC presentation.
5)Potential £100m market in the UK.
6)Specialist Commissioning being pushed for.
Stroke Test
1)Public consultation which started in May 2023 finally ended today after multiple delays. Publication date is scheduled for the 10th July....though NICE approval could come earlier James Cheek in the IMC presentation: "Cannot see any reason why anything will change to the final recommendation".
2)UKCA certified which permits sales within the UK.
3)DEVOTE study anticipated completing in May with submission shortly thereafter.
Negatives
AIHL
1)The de novo submission to the FDA is anticipated to start in late 2024, subject to funding, according to the CEO in the IMC presentation.. So some way off and the caveat of "subject to funding". But the new partnership should help!
2)Specialist Commissioning might not be before April 2025 though earlier approval is being pushed for.
Stroke Test
1)The review process following the DEVOTE study is anticipated to take 5 to 7 months, so some way off.
Finances
Positive
1)No Riverfort overhang at present.
Negative
1)Urgent need to raise funds.
So there we have it. Lots of potentially positive news flow but the elephant in the room is the urgent need to raise funds.
Public consultation ends today so from this moment on all eyes on the NICE website.
Bye Bye...!
Time to say good bye all .. My prediction has happened .. so as I am a man of my word ... I would like to take this opportunity to wish you all much prosperity and good luck with GDR (going to need it ) and life ..
May the gods bless ...
N5
It’s pretty simple. GDR isn’t an investment it’s a trader’s share.
The buy and hold strategy for Genedrive has been a complete and utter disaster, as any number of long term holders on here, significantly under water, can attest, and often do.
The money to be made here (apart from River Fort and management) has been either on the Short side (and they have every financial incentive to trash the share’s reputation on here obviously), or from the relatively frequent, sharp spikes, caused by short covering and speculative longs.
That is what keeps some of us on here. Waiting for opportunities. Which may come after a raise, presently. If there wasn’t any prospect of making money I certainly wouldn’t waste my time on here myself and I doubt others would either.
You do realise that suggesting that only current shareholders have the right to post on here is completely ridiculous, right?
Please stick to your promise tiger
Roger, AIHL test I believe for 2027 (FDA approval expected then).
Not sure if we’ll get an update regarding the consultation as I don’t think we did for the first one or with AIHL’s consultations but let’s see.
Where are you off to next Tiger? Back to the savannahs of India or instead going to adventure to the remote woodlands of Siberia?
Many thanks Tony ... spreading the love .. could be my last day on this board if we dont close at 7 p .. so any questions , feel free to ask Tiger 16... sooner rather than latter ..
Got to love Tiger!
Anyone invested in RUA, this came to my attention some time ago , guys do your own research .. remember you heard it here from me first .. GDR and RUA .. these are high risks , but big rewards if they come in ... that is if they come in ... your money , always do your own research please .. follow your instincts .. not anyone on here , including me
I believe we should get a Rns TODAY , I believe it will be after hours so they can re rate on Monday ... there is always a leak , for those in the know , which is not me lol, wish it was ... hence i believe a 7 p close today ...
De Novo route is quicker as well , 150 days from full application , so if we look at 12 months research then 6 months ish for news.
Actually thought the de Novo route was even cheaper than that. System, yes think yr £2m for normal route is about right and probably what will be needed for the CYP2C19 test. Let's just deal with one financial hurdle at a time for now.
When Gino said start of 2027 was that for the AIHL test or CYP2C19? I can't recall now.
£2 million for other route..?..
Roger , from memory FDA application is about £500k for De Novo , much cheaper than other routes , as for trials , dont know.
All of that article can be debunked with statistics. We aren't drinking more we are drinking less and that has been the trend for decades. We are exercising at the same amount as pre pandemic levels, and stroke cases are almost identical yoy for the last 10-15 years despite population growth. So why are they telling us they expect a FIFTY % increase over the next 10 years?
GDR has some cash in the bank at the moment. I think it can last for about another 3 months... It will get another tax R&D refund of hopefully about £1.2m again next March. If AIHL test sales continue to ramp up perhaps that could even bring in £500k before the end of 2024.
That means GDR only needs to raise about £3m to have enough funding to see it past the point where CYP2C19 will gain FULL recommendation from NICE and at which time surely the sp and mcap will rise significantly?
What we don't know is how much money is needed for the FDA clinical trials or the FDA De Novo application. We have been told it is much quicker and cheaper than the usual routes so here's hoping we avoid the worst case scenarios in all aspects and can finally believe we are turning a corner to better times..?
🤞🤞🤞
Hopefully we stay under 6p today...so that,LL be the end of ..Tiger16 posts forever...!..😂
Neither does he but still got a seat on the GDR gravy train🤣🤣
Well said Guy. 2019 for me, but I sold out earlier this year and am now back in to try and recover losses.
But no, they’re right, we should be grateful and stay silent and not say a word about the appalling mismanagement and dismal performance in share value .
Anyway, I do actually think we’re close to something major here. Whether that’s admin, going private or a big spike and funding announcement I’ve no idea but one thing is for sure, GDR can’t survive for more than a few months as things are. Cheek resolutely refuses to reduce the monthly bill from £400k so he must have a plan….we just don’t know what it is