Member Info for Mrgeeebeee

Are the finally out, seems to have flatlined today 🤔🤞

Just buying in now at .05, crazy price for a new mine about to go into production. Who gives a f look about the price a year ago.. what a plonker, change your name to Rodney……

Hi RachT, appreciate your balanced view on 80M, can you elaborate on the ‘ , but you have failed to address any of the issues NOW threatening / facing 80M’ piece please?

Almost 2 years now since pre sub for FDA , surely we are close now after BDR recently

5 Oct 2022 07:00

RNS Number : 7594B

Genedrive PLC

05 October 2022

Yes exactly and Eureka actually concurs._

I do believe that is where the confusion is, they are uncertain as to what route to take for FDA for CYP219C, but are following De Novo pathway for RNR1.

It was confirmed in the RNS that Genedrive would pursue De Novo pathway.

“ genedrive intends to pursue the FDA De Novo regulatory pathway for entry into the U.S. market. The FDA De Novo pathway provides a vehicle for establishing new predicate devices that can reflect modern standards for performance and safety and can serve as a basis for future clearances. De Novo classification is a risk-based classification process used when there is a lack of a predicate device already cleared by the FDA. ‘

The breakthrough device designation will speed up the De Novo pathway, it has already begun back in July….

GLA

Muminr, I stated that the average time is 2 to 3 months, I used the links at the bottom of the web site link and looked at submission date and approval date . Click on the Market Submission Number and review the dates and check out the summary. This is just my opinion.

Https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

The future of this company's success is with FDA approval of its products, firstly RNR1, it now has breakthrough device recognition, average time for approval is 2 to 3 months, DYOR on that one but check out FDA website for 2023 breakthrough approval requests and time to approval for results, especially POC buckle swabs. Nothing coming from NHS for a few years imo, I will leave that to your own thoughts on how investment in the NHS is managed. Good price at present and plenty of upside GLA LTH….

Hello Raaydaar, interested to get your thoughts on BCE as you were an avid fan of that share in the past, now in suspension, clearly your judgement is questionable , don’t seem to be able to find any history of your posts on BCE but do remember you being on that BB. Not an avid fan of your insights, good at predicting failures any tips on good investment opportunities? 😂😂😂

Can’t see why you lot are wetting your pants over this share it’s at an all time low with plenty of uplift potential get in now whilst you can. Could be worse you could have followed raydums advise and bought BCE, 😂😂😂😂seriously DYOR

‘ Whilst positioned primarily for enabling near-patient testing, the Genedrive® System is also suitable for traditional laboratory testing paradigms as a more affordable alternative to laboratory platforms where sample throughput requirements do not necessitate high-scale batch processing’

Training in the North West over the last couple of weeks on the RNR1 , news in bound from all fronts. GLA current and prospective holders….

Https://www.pulsarhelium.com/helium-projects/tunu

Sums up your posts, thanks for clarifying your state of mind Cat….

Lloyds have taken my money for OO and additional shares I subscribed for. However in their notes they suggested they would take all available funds for subscription shares and any extras on or after the 26th May, but if the raise is unsuccessful or is over subscribed I would get my money back post the GM. So the fact that they have taken the money is no guarantee the raise has been successful. I do hope it is for all those invested, trading or long term….. 🤞🤞🤞

Quote from RNS 14 May 07:00

“ The Fundraising (excluding the Firm Placing) is conditional on, amongst other matters, the passing of the Resolutions at the General Meeting. “

Don’t the resolutions have to be approved at the GM, if approved the shares and any extras, if requested and available will appear in your account on 3rd June

@ TM - The only Hardman report I see was published in 2019, would please share the report you are referring to?