Member Info for TheWatcher2022

https://www.manchester.ac.uk/discover/news/genetic-test-to-prevent-newborn-babies-going-deaf-recommended-by-nice/

Shame I can’t top up my ISA!

Think we may have a decline in SP until end of month and then an increase in March and then boom!

Blimey at this rate we will turnover more than 49k this year! Here comes the revenue by the looks of it!

A worlds first at last!

I can’t find this either is there a link Kev?

Correction the saving on the £65000 implants is 13million this excludes on going cost for the patient and any compensation paid to the family and any disability payments paid weekly in the future. This is based on 200 drug related issues causing deafness that would be prevented by our product. This is based on the UK NHS tweet.

I would like to know what the worldwide saving is?? Must be over a billion pounds!

=81million!! Not a bad saving and this is just the implant saving only! OMG

Around 1,249 babies are born in England and Wales with the variant each year. At the moment, babies treated with gentamicin who go deaf are only discovered to have the genetic variant with DNA testing afterwards.

The estimated cost of treating hearing loss with a bilateral cochlear implant is around £65,000 in the first year.

Looks like the new SP will sit between 25/30p until further news or insider information. Should have spotted the NICE recommendation when the SP started to rise in the new year!

I presume there are already PoC devices with swab tests in the US detecting other gene sequences? I hope so as by the looks of it we need it to go down this application route?

Substantive Review

“As part of substantive reviews, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm the device is eligible for De Novo classification”

Dave

In my opinion the NICE recommendation is a major help and the fact the test is only swab based also helps.

I had a brief scan though the following links but don’t fully understand FDA processes. https://www.fda.gov/search?s=De+novo

I’m only looking at facts either PDF’s or web links, all investors should make their minds up either right or wrong.
I’m fairly new to investing and have already been burnt by taking on board peoples pipe dreams! Luckily doing research and having a bit of luck I have recouped losses I made in the past.

I wouldn’t invest any money If posters are stating 10 bagger £5.77 by Christmas & sales are rocketing!

49k proven sales last year, doesn’t even pay for the GDR Christmas party IMHO!

Roll on the 30th!

Bigal’s email and post from NICE on the 10th

The final publication is expected on the 30th of March. This has been confirmed by the email and link the further down todays posts. Roll on the 30th!!!

RE: Some great media interest!10 Feb 2023 11:26
Hi stephen11,

Just received this email reply from NICE:-

National Institute for Health and Care Excellence (NICE)
Fri, 10 Feb at 10:42
Thank you for contacting the National Institute for Health and Care Excellence (NICE) regarding the developing guideline on Early value assessment: Genedrive MT RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies.

The expected publication on the above is 30 March 2023. We currently have a public consultation which is running until the 21 February and more information can be found on the consultation pages.

I am sorry that you have had difficulty getting through to us, we are aware of an issue with people queuing for periods of time and we are currently working to get this resolved as soon as possible. Our phone lines are open 10-4 however, I would suggest in the meantime that you continue to email the enquiry handling team at nice@nice.org.uk.

Kind regards
Katy

Katy
Communications Executive
National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Tel: 0300 323 0141
Web: http://nice.org.uk
My current working hours are 8am – 4pm Monday to Friday

It’s the end of March as someone had an email from NICE. If you go through the posts you will find it. Think it was on the 10/2?

Blimey that’s interesting, maybe there would be a likely buyout. Very interesting link about the good doctor that has sold many companies!

Must omit after reviewing some of the posts I do like the comment D.Budd left on his first LSE post!

“I don’t check in here very often – would be hard on my mental health I fear. A few well informed and well considered posters on here, and a few absolute nutters apparently too, but you know that already”

let’s hope for some further good news before the NICE publication. GLA

System hard to say!? I would like a rise but you know what being in GDR is like ;)

Depends if Budd has something up his sleeve.

Probably bounce between 27-30p range, assume it will be like this until 10 business days before the 30-3-23.

Thoughts?

To members discussing funding/sales and Facts, it appears there will definitely be a raise between Apr-June 23 unless funding comes from other sources such as some form of NHS sponsorship. Obviously if the NHS pour extra funds in they will want free product or product at a reduced rate.

Fact: year end will be 30 June 2023.
Fact statement: “ The net proceeds of £6.6m has extended our cash runway at least towards the end of our 2023 financial year using a prudent forecasting basis that excludes all revenues”

“ We are confident in gaining commercial traction and securing significant revenues, but due to the time required to achieve this, we will require additional funding in our 2023 financial year”

Fact: last year we had a revenue of 49k
Fact: Tax credit of 1 million in 2022
Fact : inventories (assume product in stock) £748k 2022

Positives: NHS/NICE/FDA/ 1 product that is ready for commercial distribution or sales RNR1, stroke maker product that is near R&D completion. Potential of sales/revenue or take over bid from large Pharma.

Negatives: no revenue, competition from another R&D on stroke marker NICE evaluation, fund raise, too late to the market with COVID product.

Summary: lots of positives but still risk but with the upshot of a lot of rewards!

GLA

It would be NICE for some positivity on this board today! Suggest taking the playground chat to another platform really!

What I would like to see are some commercial PO’s or contracts coming through confirming the headlines the BBC offered up on the 9th. It clearly states “to use” obviously this will be on the basis of the NICE rubber stamp at the end of March. https://www.bbc.com/news/health-64570089.amp

Has anyone stopped to think and thought I wonder if GDR have got stock of any machines ready for commercial distribution via IHC?

Have IHC got 2 or more machines in stock ready for dispatch? Have IHC got a demo kit they are currently taking to Hospitals and trusts?

Are other procurement teams from NHS trusts, hospitals or overseas visiting Manchester or Liverpool units to witness and demo the technology?

How about the assay pack? Is there any stock at GDR or IHC ready for distribution?

Are there any commercial contracts in place to manufacture the machines and assay packs? We must have an agreement with someone to manufacture the machines? I can’t see the units in Manchester and liverpool being manufactured in David’s garden shed! We must be paying someone to build and assemble these machines, we
have an indicative sale cost for these machines but what is the assembly and cost if we are selling 5k of machines a year?

I would like posters to be offering up any information we may have missed so far about any attempt at commercialisation of the product.

There must be some info somewhere otherwise it is pointless having the commercial distribution partner IHC.
Why we would we have a distribution partner if we had no stock or if it were on a 3-6 month lead time. This would seem pointless considering we are at a point were we could see PO’s and contracts to generate revenue.

I just want to understand how GDR attempt to commercialise their products and if they are already in the process of this? Or are they thinking of doing a dragons den style pitch to a major pharma and stating here is are NICE badge/product and the business model to commercialise and sell the product.

Any info people have with genuine links or PDF’s would be greatly appreciated by all posters.

One thing I noticed in the NICE documents is below which appears to give the NHS a green light to use and procure the product:

1 Recommendations
1.1 Genedrive MT-RNR1 ID Kit can be used, while evidence is being generated, as an option for detecting the genetic variant m.1555A>G to guide antibiotic (aminoglycoside) use and prevent hearing loss in babies.
1.2 Healthcare professionals should tell parents about the possible implications of positive test results for their baby and their family at an appropriate time, and give support and information.

Boom Boom! GLA

P*ss taker!