Member Info for DSFLAT

Before you all say DSFLAT is a conspiracy fanatic nutjob just listen to Bill & Mel and perhaps consider the focus on Tuberculosis injections by the Bill & Mell Foundation (airborne, which has also apparently seen the biggest rise in 20 years)

Genedrive have been working on a TB diagnostic test which 'could' if as a conspiratorial mind like mine might suggest will be the 'next pandemic' could actually be a BIG seller, but we will have to see if my prediction is correct..(two years max)

If you missed it here is Bill & Mell:
Bill and Melinda Gates announce next pandemic will get attention this time.
https://youtu.be/UD_FfYW23ZQ

G20 Bali,

Argentina, Australia, Brazil, Canada, China, France, Germany, Japan, India, Indonesia, Italy, Mexico, Russia, South Africa, Saudi Arabia, South Korea, Turkey, United Kingdom, United States, and European Union.

These psychopaths are already getting their Ducks lined up ready for the next bull**** pandemic.

Dr. John Campbell
652,884 views Nov 19, 2022
G20 Bali Leaders’ Declaration
https://youtu.be/zVBcITMAqnM

Should be good for the sp here but not something anyone can honestly look forward to :-/

I don't want too rampy but I noted that one of the experts reporting on NICE noted that although the MT-RNR1 test was very quick it could delay antibiotic treatment and suggested it might be better to simply risk loss of hearing rather than delay treatment by 26 mins (from memory)

In this report: Mitochondrial mutation m.1555A>G as a risk factor for failed newborn hearing screening in a large cohort of preterm infants from 2014 it concludes:
Conclusion
Antenatal screening for the m.1555A>G mutation by maternal genotyping of pregnant women with preterm labour might be a reasonable approach to identify infants who are at increased risk for permanent hearing loss.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4236616/

Obviously any decision to proactively test all mothers rather than wait for a potential emergency birth situation would be a gamechanger.

The USA as an example has healthcare insurance which looks like it may cover expecting parent Genetic testing costs (Not confirmed but I have seen suggestion of this being the case) and with a birth rate of circa 4 million the potential for MT-RNR1 could be far greater than many expect if the test were given to all pregnant women.

I know, it's rampy but there could be a reason for Antenatal screening of Mitochondrial mutation m.1555A>G using MT-RNR1 to avoid any treatment delay and particularly in the US avoid legal recourse.

Just my thoughts

I suspect that as soon as FDA new product applications are made there will be some very interested USA Genetics companies taking a much closer look at Genedrive.

I know The Motley Fool isn't usually associated with quality info but this article provides some insight into the US Genetics market:
https://www.fool.com/investing/stock-market/market-sectors/healthcare/genomics-stocks/

There is also a recent USA report, by non-profit group March of Dimes that 383,000 (10.5 per cent) of births were before week-37 last year researchers said, a four per cent increase on the 364,000 infants in 2020. Last year's figure is the highest since records began in 2007.
https://www.dailymail.co.uk/health/article-11439993/One-TEN-newborns-born-prematurely-rates-hit-record-high-report-warns.html

GDR will most likely attract a lot of USA attention with MT-RNR1

A delete post option would be really helpful on this platform sometimes!

I hope I didn't offend anyone with my posts last night and sincerely apologise if I did.

I'd had a few Whiskeys after the GDR rise yesterday and I should not have been posting on here.

I looked on StockTwits and GRND was up massively and thought I'd typed GRD by mistake on here.

Sorry

Obviously important that the BOD go down the correct FDA submission, the pre-submission will ensure they get it right first time.

FDA Premarket Submissions: Selecting and Preparing the Correct Submission
https://www.fda.gov/medical-devices/how-study-and-market-your-device/premarket-submissions-selecting-and-preparing-correct-submission

If the FDA pre-sub findings point to a 510(k) Premarket Notification and the BOD go ahead with FDA before NICE comes in (eta Feb) investors might get the jump on that RNS here:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

I stand by my prediction (a few weeks ago)

All
Current Public
Traded
BTC
Miners
Will
Fail

Obviously time will tell but my best guess is that they are ALL doomed

Grinder is up 257% today lol

F..k
m.
A....

Total coincidence with my post, I swear x

Jezz what a world this is (crazy as F..k emoji)

When FTX Sex Tapes lol (puke emoji)

I knew someone would know what Grinder was lol (didn't know they had it in Thailand:)

It's that Japanese Whisky you have to be wary off lol

The kind where you wake up in the morning with a sore A..e :-O

Results could be nothing much on Monday but the focus should (imo) be on next year NICE/NHS & FDA approvals of Genedrive® MT-RNR1 Test.

Obviously the stroke marker test could be even bigger for GDR but lets get MT-RNR1 confirmed first...

Could be some very good things happening here next year

GDR

GRD is Grinder :-O

Bloody
Whisky
lol

GDR
Had a good day today
Results monday (not expecting much)
But FDA & NICE/NHS approvals early next year
Could
Be Very good for GDR

FTX & Crypto is a right mess right now but in a few years it will hopefully
All be forgotten
Ready for the next
Bull Run

Just thought I'd have a go
at whatever it is this board
Is trying

Nice finish

But regardless of Monday's results I'm looking for £1+ next year when NICE & FDA approvals come in and this stock finds proper value.

Can't get a buy quote on HL

I'd say that's a good sign ;-)

Might be that the BOD are aligning the 510 k with NICE approval to avoid additional costs and potential setbacks..

Genedrive could decide to use a 510k FDA device clearance company like this one:

'The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process. This average pricing model is based on the fact that the pending product has a already been approved in another major country that has a governing regulating body that approves or denies new medical devices. If a new product or device does not have any approvals in any country, the cost of the FDA 510k approval process will increase substantially as the manufacturer will now have to conduct numerous new product tests for usage, performance, safety, sterilization, bio-compatibility, electrical, and technical.'

https://510kfda.com/

The BOD could choose to save a few pounds and do it themselves, but I suspect they will engage professional services to ensure things go smoothly.

Looks like as soon as the FDA Pre-Submission is complete the next step will be a Premarket Notification 510(k).

'Once the device is determined to be SE, it can then be marketed in the U.S. The SE determination is usually made within 90 days and is made based on the information submitted by the submitter.'

Surprisingly quick and inexpensive process to permit US marketing of the product.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k

'genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that it has commenced engagement with the U.S. Food and Drug Administration ("FDA") to progress the regulatory approval of the Genedrive® MT-RNR1 ID Kit into the USA.'

More likely the process started before Oct, probably in September. (I'm more of a glass half full so I expect an update soon;)

When Should I use the Pre-Sub Program?
Pre-Sub program is useful for a wide variety of regulatory strategies, however in terms of medical devices, it is particularly useful for those that 1) do not have a clear regulatory pathway, 2) utilize a novel technology, or 3) have indications for use that qualify them as a “first of a kind” device.[5] While not required, the net result of a Pre-Sub is targeted, written feedback from FDA. Adherence to such feedback is of great value in terms of quality and compliance and highly desirable for those devices that might require more information to ensure a submission that FDA will accept for filing. In short, early feedback from FDA tends to ensure better quality data for inclusion in the actual FDA submission. However, Pre-Subs should be conducted prior to compiling any device documents or studies and it is important to keep in mind the Pre-Sub lead times (75-90 days timeframe for meeting or teleconference, 21 days for urgent public health issues.)

Wed, 5th Oct 2022 07:00
RNS Number : 7594B

Pre-submission process:

Here is an outline of the FDA Pre-submission process:
?
1. Sponsor submits to the Document Control Center (see mailing address above)
2. FDA conducts acceptance review (14 days)
3. Meeting/Teleconference requested:
a. FDA works with manufacturer to schedule the meeting/teleconference (21 days)
b. FDA provides preliminary feedback via email (at least one week prior to the meeting/teleconference)
4. FDA provides feedback (70 days)
5. After Meeting/Teleconference held:
a. Manufacturer provides draft minutes to Document Control Center (15 days)
b. FDA reviews/edits minutes (30 days)

https://www.cosmhq.com/resources-posts/what-is-an-fda-pre-submission