Member Info for EmeraldCarrots

To my post or what! You underwater already with the 41% rise last Thursday? If so you'd better pray the FDA have not fast tracked GDR's FDA application......... sorry , they have done that already have they not (See RNS!). When the FDA approval RNS appears anyone with a short positon will be crying. IMHO the sp will more than doube.

All IMHO.

To my post or what! You underwater already with the 41% rise last Thursday? If so you'd better pray the FDA have not fast tracked GDR's FDA application......... sorry , they have done that already have they not (See RNS!). When the FDA approval RNS appears anyone with a short positon will be crying. IMHO the sp will more than doube.

All IMHO.

Simply getting clearance for hospitals in the USA to buy and use the machine is absolute key. To be honest I forgot the RNS was 3 months age. So it could happen any day from now on. Expect a spike in sp price to 5p or more on RNS confirmation.

All IMHO.

Thursday………Hmmm.

https://www.qualio.com/blog/fda-medical-device-approval-process

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months.

==========================

https://www.lse.co.uk/rns/GDR/breakthrough-device-designation-from-the-us-fda-2zclfstav7guqaq.html

The FDA want to improve the time it takes for approval, that is well known. The article says 19% of de novo applications are cleared ***within 3 months***. It seems to me with the Genedrive hearing version there is not much to check? They must have a lot of data from the NHS. When the machine is used the result is checked in the NHS lab system (taking a couple of days or more). If they have sufficient data backed up by the NHS lab results, what better data could they possibly have? The RNS was on 15th July.

https://www.lse.co.uk/rns/GDR/breakthrough-device-designation-from-the-us-fda-2zclfstav7guqaq.html

15th October is 3 months. That is NEXT WEEK. I SUGGEST THE 41% RISE IN THE SP LAST THURSDAY is to do with the FDA application!!!!!!!!!!

All IMHO.

Happen in November. As far as cash burn goes even if they do need another one as long as the market can see massive profits coming a placing could be above whatever the sp is at the time. Placings are not always a big dilution. Also in a year or so what will the sp be.............10p a share? With FDA approval I can see that. I can't see Americans taking a chance with their babies hearing, can you? Also would the parents not sue if it can be shown the hospital did not check? On FDA approval the orders to Genedrive will EXPLODE. Big pharma takeover likely.

All IMHO.

Either machine now. Great products, a massive market, NICE recommendations for the nhs to use and now the NHS following on with explaining to their staff what the machines do and how to use them. The 41% sp rise Thursday 10th March tells me the penny has dropped with one or more investment houses.

All IMHO.

Https://poctinnovators.com/the-genedrive-system-using-the-genedrive-mt-rnr1-id-kit/

Correction. 29mins 30 secs, not 28mis 30 secs.

=========================================

Where Genedrives MT-RNR1 test

https://www.infantjournal.co.uk/nicu_list.html

Https://youtu.be/WdVGXFCiFh8?si=AXdSJB-myuxOle6m

https://www.lse.co.uk/rns/GDR/breakthrough-device-designation-from-the-us-fda-2zclfstav7guqaq.html

https://www.lse.co.uk/rns/GDR/initial-orders-of-the-genedrive-mt-rnr1-products-fgwrxyuxsxsjyho.html

Where Genedrives MT-RNR1 test

https://www.infantjournal.co.uk/nicu_list.html

Https://youtu.be/WdVGXFCiFh8?si=AXdSJB-myuxOle6m

https://www.lse.co.uk/rns/GDR/breakthrough-device-designation-from-the-us-fda-2zclfstav7guqaq.html

https://www.lse.co.uk/rns/GDR/initial-orders-of-the-genedrive-mt-rnr1-products-fgwrxyuxsxsjyho.html

If the Directors are in a parallel universe, I'm thinking it might be against the FSA rules? Although I suppose as long as you put the correct address on the form it does not matter where you live? Interesting one.

If you want to buy.

All IMHO.

In a parrallel universe and talk to shrubs.

The machines probably either don't exist. or would malfuction if brought over to our universe.

It's a sell if you ask me.

All IMHO.

Both their machines now. Just because NHS's own videos are educating the NHS staff on when they should be used and how. Just because 1 machine is being fast tracked for FDA clearance by the FDA themselves because they think it is unique and needed urgently. I mean, what the hell does that matter? SELL SELL SELL!!!!!

All IMHO.

Was thinking about it.

GDR machines to NHS staff is happening already! The sales will obviously snowball as you can't use a machine if you have not got one!!!!!!! LOL!! FFS!!! But now and reap the rewards in the weeks/months ahead. The sp is silly low.

All IMHO.

Ok, fair enough. The sp was up a lot the day before as well so over 3 days even more.

Is educating it's staff about the products including when and how to use them. Therefore the NHS are/will be buying the machines. This is why the so went up 41% yesterday, did you not notice? I assume you are an adult, although there are all ages on here, unfortunately. The sp may be 16% down today, but that means it's 25% up over the 2 days. 25% UP.

All IMHO.

Example of a poster on here that should without a doubt be banned.

However I still hold a shed load. NICE has now recommended both the machines use in the NHS. And now the NHS is telling it's staff about the machines, what they do and when they should be used. Difficult if your hospital does not actally have any one would have thought??

Makes one wonder if the big investors are on the ball frankly. NHS recommandations lead to international sales as well. Also one of the machines is being fast tracked by the FDA for FDA clearance (so it can be used in anywhere in the USA!).

What more can you say. Is the market dumb maybe??

All IMHO.

However I still hold a shed load. NICE has now recommended both the machines use in the NHS. And now the NHS is telling it's staff about the machines, what they do and when they should be used. Difficult if your hospital does not actally have any one would have thought??

All IMHO.