Member Info for 1DayRodney

I think AIHL is a certainty because it's been a bit of a crusade of GDR and is essentially being driven by the NHS who are in waiting. The new sales team for it will also hopefully be hungry - I just hope they don't get dragged down.
The CE qualification 'should' also be ok because the system has been certified before, it's just been upgraded after consultation with the NHS so had to be resubmitted (I guess).
All the above has to happen when promised otherwise the company will be severely punished.
I think based on AIHL alone, it should see us back in the low 40s once sales start. This is when II's may start unloading their 24m shares knowing there'll be buyers.

As for Covid POC, until we see the RNS confirming the CE qualification the market will not yet factor it in because of past constant delays. CE qualification may give the price a small temporary uplift but nothing proper until sales. Again, we need that new sales team to be hungry!
I also think (unfortunately) both placings need to be fully subscribed to give us the best chance. Hopefully this will at least increase liquidity too.

I was wondering if the future monthly burn rate may lessen (excl. DB bonus!).
We've been developing 3 products at the same time this last year and two of those should be moving to sales stage, just leaving just TB assay confirmed as in development.

I think Genedrive needs to evolve quickly from its research based ethos to a commercial and sales based one or it will wither.

Research and product development is still very important and we seem to have some excellent technical staff but it all costs money. The company needs to grow up, mind the pennies and start taking on the sales and promotional side far more proactively.
BOD should be rewarded on market value, sales and growth, not default bonuses.
I can't remember once seeing one promotional article in a medical/pharmaceutical trade journal/magazine or trade show by GDR for any of their products. No "see us in the month's 'Stork and Gooseberry Bush' magazine". The sorts of things that should be on the website.
The AIHL trial was resounding success medically, but relying on the trial leader's tweets only for promotion is ridiculous. Same goes for HCV and PCR relying on retweets of 3rd party studies.

Let's hope in the hands of IHC the AIHL POC gets a good hearing (pun intended!), sales take off and infants saved from potential disability.

@ Jay
Best of for the little'un but you might wanna keep some of them nappies for yourself ;)

This is a real world business with real investors' hard earned money and not an episode of 'The Apprentice'.

The lab PCR test sales failure needs to be seriously scrutinised and questions answered. Among them:

# Why, with the product CE marked, did we not try to sell to the UK and EU markets as well as applying for FDA EUA. Were the BOD mesmerized with the glitter of the Yankee dollar pot of gold or did our CEO's past/'connections' taint their decision?

# Would it not have been far more straightforward and cost effective to develop an alternate container format if the '96' plate was not favoured in qualified markets (as mentioned previously I believe)

# Was the price point indeed too high? Were we trying to re-coup the cost of development too early instead of creating lower initial cost mass volumes sales with repeat customers? In that initial scramble for tests in the UK at the beginning of the pandemic we could have stormed it with such a unique format. Selling nothing recoups nothing!

# Why have our distributors e.g. BC, Sysmex and DIVOC failed so?
Mr Budd sent out a resounding slap in the face RNS by declaring we were too expensive for the India market, so why did waste money qualifying for it and why did he push India as a market to investors in the first place?

# Who is the person immediately responsible for direct sales and distributor liason within Gendrive and why did they not perform?

# Why did we insist on putting multiple test formats through the FDA (which seems to be the initial cause of the delayed submission) rather that get in fast with what was ready and follow up/amend later or were just plain caught napping?

# What's the likelihood of ever getting EUA?

# Who researched the market for the original concept of the bead test format? What changed from the original market research?

There are probably many more.

The investor is being asked to help bail the company out of this woeful situation but with two raises, multiple dilutions and conversions, dreadful comms, misleading presentations/media plus an apparently undeserved pay/bonus regime over the last 18mths, all goodwill has been eroded here and with the market. It's a tough swallow.

HOWEVER, I BELIEVE THIS PARTICULAR PRODUCT IS STILL A GOOD PRODUCT - IT SHOULD NOT BE WRITTEN OFF YET BUT INSTEAD TURNED AROUND!
BOD, PROVE YOU'RE MADE OF THE RIGHT STUFF - GET IT DONE!

Not the RNS I was hoping for!
Certain salaries and bonuses were very premature but with so little comms it was difficult to challenge with facts one way or the other. A tough AIM lesson learned..

However, I don't know how many have read the proposed circular wording at the end of the RNS?
It give some recent sales figures, product status and predicted sales figures for the AIHL POC. Also expected costs if the AIHL test were to be put through FDA.

AIHL info quoted from the RNS -

"FDA approval and US registration is not funded by the Placing however, should the Company raise a minimum of £8 million via the Placing and the Open Offer, the Company's intention would be to accelerate the commencement of US studies, and expects that £2 million would be the total cost for the FDA submission and approval process.
 
 
The Company is targeting an assay price of around £60 for the UK NHS market and is initially targeting three to five sites for the launch (study centres and close supporters).  genedrive is expecting to achieve first sales in the UK in Autumn 2021. The Company also has an EU pilot site identified.  Based on extrapolating population sizes and birth rate, the Company estimates that there are 180 sites it could target in the UK and a further 1,000 in Europe with around 100,000 and 550,000 infant intensive care admissions per annum in these regions respectively. 
 
The Company estimates that the total addressable UK market is up to £5 million per annum with Europe potentially another £30 million per annum. The Directors believe that the UK and Europe presents an attractive market opportunity for the Company to target.  The Company expects to pursue a direct distributor model alongside some investment in its own business development activities including a direct selling and support team of less than eight people which will be complimentary to IHC and help drive initial adoption.
 
In terms of the US opportunity, that market is estimated to have 900 sites and 500,000 infant intensive care admissions per annum and a market opportunity in excess of £20 million per annum."
- end.

It's a pity this news was not more forthcoming earlier! Demonstrates a contemptuous attitude towards all shareholders.
The BOD probably realise that a lot of shareholders (PI & II) can't really sell at these prices so will have to take up as much of the placement as possible, thus ensuring its success.

This looks a longer term holding now....

Hi ishy,
all the info you want is in the link below. Officially it's only a proposal at the moment until it has been officially adopted at the General Meeting.
I suggest you read all the way to the end. After the initial announcement and legal wording, there's more info from the company about the future of its products.

https://www.londonstockexchange.com/news-article/GDR/proposed-placing-and-open-offer/15131362

HTH

That BMJ article is not the trial results but the trial protocols i.e. the premise and study method, along with the ethical considerations, and was published some time in May I seem to remember.
The performance and results of the trial are what is being presented by John at next week's conference (presumably along with the simultaneous publication of the full associated report document).
Will be interesting to watch the health industry's reaction as well as the SP's reaction once it's publicly gained some traction.
This is a make or break and there's no hiding for the BOD on this one:
?Unique quick test
?Non-invasive and easy test to perform
?Saves babies from potential disability
?Save health services money
?An excellent distributor already on board
?A gateway product to our other Genedrive assays.

Cuz itz cheep az chipz!

"The bit I like is that once an organisation has bought a load of the Genedrive devices for say AIHL or HCV in mind, it seems highly highly they will then want to order a load of cost effective covid tests to run on it too."

Although the Genedrive device itself is generic, I don't believe it is not a 'hotswap' device where the same particular unit can be used for multiple assays. It's my understanding that each 'version' has tailor-made software and maybe even cartridge style to suit each assay and its medium e.g. nasal, buccal swabs or maybe even bloods in the case of TB or DOD.
However, once a Genedrive has been bought, there will be the continuing revenue from replenishing the assay catridges themselves.

I'm happy to be corrected if wrong.

Some interesting larger trades going on today.

Someone fell out of love this morning with a 1 mill sell, only for the fair maiden to be swept off her feet again with three large trades of 500k,776k and 800k after the bell.

Certainly making this share interesting, if a little volatile :)

"PIs just cannot cope without tweets."

That's not the problem here and I think it's also an unfair reflection on PI's. The problem here (as I see it) is lack of confidence in company's performance and actions causing the share price to continually diminish at an unerring rate. I'm sure 'PI's' could cope perfectly well without tweets if the share price was sensible and stable.
For this company to grow and move forward as a mature and progressive concern, we need far more stability in the share. This last year's multi-rollercoaster of a ride will only make a traded company rather than an invested one. Future II's will view that as unattractive.

I keep seeing the figure of '18mths' being 'no sales' quoted but I'm a little confused. If we're talking about our SARs product, it wasn't CE marked 'til end of May last year, which is surely just over 14 mths.
I agree the sales of the lab product have to date been dreadfully underwhelming but let's not drub the company with over exaggerations.

However, on a another point, this week it's exactly a year since the collaboration with Beckman Coulter was announced by RNS.
May be the BOD are waiting to mark the occasion with a nice juicy trading announcement.

One can dream....lol!

Quoted from the trial summary..

 "The sensitivity (100%) and specificity (97.2%) for the GeneDrive HCV RNA assay were the same as the gold standard test. Agreement between Abbott Real time PCR and GeneDrive is 99.4%. 

CONCLUSIONS: GeneDrive, a novel POC HCV RNA assay yielded a high performance to confirm active HCV infection. To ending hepatitis C in resource limited settings (RLS), this portable POC device is a good alternative to facilitate 'Test and treat HCV' in a real clinical setting in many RLS."

For those without Twitter or LinkedIn, this posted by genedriveplc about 1hr ago...

"High performance data presented at IAS conference. The Genedrive HCV test was successfully used in a Bangkok prison to confirm active HCV infection in a high risk population #genedrive #gdr #hepatitisc #molecular #HCV #worldhepatitisday #viralhepatitis
https://t.co/l1KiQQW9a1"

(IAS I believe to be the International Aids Society)

@Jac
No heads buried here and your implication of me or my view (which I had not stated) as being pathetic is rather high handed, condescending and arrogant.
My comment was merely suggesting you give it a rest for the weekend and chill out. It was not in anyway in opposition or disagreement with your post.

@roger65

Fully developed and currently on sale to multiple markets. Awaiting FDA EUA even though it on limited sale for certain lab use as declared to and acknowledged by the FDA.

https://www.genedrive.com/assays/sars-cov-2-kit-product.php

Recently developed and currently going through CE qualification prior to marketing.

https://www.genedrive.com/assays/in-development-covid19-id.php

@Jac
Go outside and enjoy the beautiful summer :)

I don't have a specific figure in mind, but IMHO £2.50 is too low.
We have 1 product at the start of its commercialisation (HCV) and looks likely for global sales, 2 at commercialisation (DOD & SARs lab), 1 about to launch with the NHS highly likely to buy (AIHL), 1 product coming to certification and commercialisation before year end (SARs POC) and 2 known products in development (TB & SARs POC Saliva).
We have unique products in the bead format and the Genedrive portable PCR device. The world has now woken up to the opportunities, advantages and necessity for accurate gentic based testing in many fields and not just for Covid.
For example, on the back of the PALOH trials for the AIHL, the head of the trial has now been given a research award to study further pharmocogenetic testing (study of drug response) within the NHS i.e. exactly what the GDR AIHL test does.

Some people are looking are looking at just getting out with some profit, and I can understand that, whereas I believe there is some real medium/longer term innovation and value here.

Interesting view from an Institutional Investor, concerned about BODs selling too cheaply...

https://www.thisismoney.co.uk/money/markets/article-9775617/M-G-Bosses-selling-firms-cheap-savers-pay-price.html

cited not 'sighted' - doh!