Member Info for TheWatcher2022

Please don’t buy back in, I’m bored of your chat!

Nothing factual at all

It’s a shame you sold out! Couldn’t have bailed out at a better time! Buy high sale low that’s my advice.

Win win win

This looks like it explains it and there were at the Arab event!

https://www.advena.mt/news/advena-awarded-the-best-med-tech-consultancy-2022/

https://www.advena.mt/about/?gclid=EAIaIQobChMIl4DRl5u-_QIVz41oCR2bOwCSEAAYASADEgJii_D_BwE

Just looked at the EC REP logo at the bottom of the pdf next to Advena medical means the following:

What is EC rep in label?
It is the liaison between a manufacturer and an national competent authority. The use of name and registerd address is on all product related labelling. A European Authorized Representative may also be known as a EUAR, EC REP, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorized Representative.

Looks to be a new EU partner unless I missed something, maybe helping to push product through EU!?

Jay

What is the relationship with these guys? Haven’t seen these before? On bottom of kit pdf

Advena Ltd, Tower Business Centre, 2nd Flr., Tower Street, Swatar, BKR 4013 Malta. www.advenamedical.com

The bottom has got to be close now, surely a tick up at 20p? I thought 25p would have been the bottom after the NICE news.

My understanding is that within the first three years they can only sell 20m pounds worth of product a year to the NHS (AIHL product). I believe we are nearly in the second year, unless the first deployment was completely free as it was in the R&D phase? After 3 years they can exceed 20m a year with the same product. I would be happy with 20m of sales per annum!

If you read the NHS link there were 4 NICE devices in 2021 and 7 in 2022, GDR are one of the seven from 2022.

The 20m sales per annum over 3 years will apply to the CYP2C19-ID Kit as we are taking the same Medtech route.

See links

https://www.supplychain.nhs.uk/suppliers/product-innovation/medtech-funding-mandate/

https://www.lse.co.uk/rns/GDR/nice-issues-medtech-innovation-briefing-lxlzccaeba4s83z.html

https://www.lse.co.uk/rns/GDR/first-nhs-deployments-of-genedrive-system-for-aihl-sm7bwht3ysreub8.html

Bankrupt is an absolute door knob and has no place on this BB.

Don’t mind truthful and honest posts but what a ****erel!

Appears investors are starting to build a position for the NICE results, could land at anytime up to and past the 30-3-23.

I would be happy with 50p

£5 a share, nothing like ramping it up!

If that was aimed at me you are talking to the wrong person!

I’ve read your posts and you have called the RNR1 a hearing test? Surely it’s a test to identify a gene? Exactly the same type of gene sequencing test as the CYP2C19.

I can’t say I have ever tried to ramp on this BB, TBF I wish I had sold out on the 10th and sat on the sidelines. I should of known better as this share tends to take the same pattern.

If anything I’m surprised you are stating hold from reading a lot of your posts.

Apologies Starres as I said I’m no expert and after doing a little research I think the 510k route is preferable over the de novo route. I must omit I listened to someone else’s post instead of doing my own research! I will not mention who’s original post I read ;)

Link below which gives more detail on FDA pre application.

https://www.fda.gov/media/131738/download

I’m no expert in FDA applications but further info is here in regards to cost.

https://www.emergobyul.com/news/us-fda-medical-device-user-fees-see-modest-increase-2022

Starres, the cost isn’t 510k and I never stated that.

The overall cost to get FDA approval for a 510(K) notification ranges between $30,000 and $44,000 USD. This includes the preparation of the submission and all associated FDA costs

For others please see extract from FDA website.

What Is a De Novo Classification Request?
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.

The FDA issued a final rule to establish new regulations implementing the medical device De Novo classification process under the FD&C Act (section 513(f)(2) (21 U.S.C. 360c(f)(2)), which provides a pathway for certain new types of devices to obtain marketing authorization as class I or class II devices. The final rule provides criteria for De Novo classification requests, including requirements related to the format and content of De Novo requests, as well as processes and criteria for accepting, granting, declining, and withdrawing De Novo requests.

I would be very surprised if we get an RNS either Tues-Wednesday. I think the below is quite clear….. I think the Eureka moment is just info we already know! As with the FDA, if GDR can’t go the de novo route why would they RNS that and bring the SP down before 30th March, don’t think they would want to risk any fund raising if needed!

Please provide any relevant information or data you have about such effects and
how they could be avoided or reduced.
Note that this document is not NICE's final guidance on Genedrive MT-RNR1 ID Kit. The recommendations in section 1 may change after consultation.
After consultation, NICE will consider the comments received. The final recommendations will be the basis for NICE’s early value guidance on using the technology with evidence generation.
For further details, see NICE health technology evaluations: the manual. Key dates:
Closing date for comments: 21 February 2023

We already know there will be no RNS tomorrow, some people have stated there could be an unlikely one.

But, the majority don’t think NICE or GDR will provide further info until the 30th or before.