Member Info for EmeraldCarrots

Sells are buys?

This happens it is confusing, to say the least.

Done around 15th July based on the following:-

RNS 31 Mar 2023

"A pre-submission (Pre-Sub) was filed with the FDA to agree the regulatory approval process of the Genedrive® MT-RNR1 ID Kit into the USA. The Pre-Sub process allows the Company an opportunity to clarify its testing and validation approach, confirm the appropriate regulatory application pathway, which are uncertain given that there is no directly comparable test in the market. The Company is in ongoing dialogue still with the FDA to ascertain the requirements, and consequently the funding estimate that would be required to conduct and manage the evidence generation and submission process.".

RNS 15 Jul 2024

"genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA") for the Genedrive® MT-RNR1 ID Kit.".

"Together with our in-place partnership with a multi-state physician led clinical partner with neonatal services expertise covering the majority of U.S. states we look forward to affordable, collaborative and timely progress through the FDA De novo process".".

As you are well aware. If you want to buy/sell shares with an established Company I suggest WIZZ or RR. You know full well if GDR get FDA appproval the sp will spike up. If you don't then you are in the wrong game!

All IMHO.

Allguessing.

As far as my recent posts on here go they are pointing out getting FDA approval in the USA opens up a huge new market for GDR. Their RNS says this:-

"genedrive plc (AIM: GDR), the point-of-care pharmacogenetic testing company, is pleased to announce that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration ("FDA") for the Genedrive® MT-RNR1 ID Kit.". That was 3 months ago. Therefore it could get approval litrally any day from now on.

All IMHO.

Lies. They should be banned for good. Nearly all my posts refer to an RNS or internet media Company so you know where my information has come from.

Since FDA application for clearnace to sell the Genedrive® MT-RNR1 kit in the USA?

They have applied for it of 15th July (probably same days before), see here:-

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

Tomorrow it's 15th October, 3 months since. About 20% of applications are granted in 3 months or less. I'm sure they will get it at some point and when the RNS dropps I will be selling a shed load on the sp spike up. You can do whatever you want. I'm sure the sp spike will be North of 4p.

All IMHO.

Does it ever happpen?

Bootnk19222

"GDR can’t sell in this country with approval".

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Be careful, would not want you to get banned (if that ever happens on this site....LOL!).

Approval in the USA. It would be worth 20 times the approval for use in the NHS (which Genedrive have already got). At least one big investor is involved now IMHO. If you have short position here and the RNS drops you will be wiped out. Completely.

All IMHO.

Is waiting for FDA approval in the USA. Do you have any idea what that means? I'll tell you. It is illegal to sell any medical device to the USA's Health system without FDA approval. So at the moment Genedrive can't sell the Genedrive® MT-RNR1 kit anywhere in the USA. You know, that country with 350 million people or so. Once they have approval they can, and the machine has been classified as unique by the FDA so there is *****NO COMPETITION*****.

Bid by a big established pharma?

All IMHO.

No one is going to push the sp here up 41% like last Thursday based on nothing. If you believe that then you must be crazy.

It's the FDA approval news expected and opening up the whole USA to Genedrive's unique "De novo" machine will more than DOUBLE the sp IMHO. Again being allowed to sell the Genedrive® MT-RNR1 kit *****in the USA**** will be ****MASSIVE****.

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

All IMHO.

Now I'm getting back in.

Bootnk19222

I don’t short stock, why do you think it went up? You think someone knows some? Really 🙄

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Are you employed to keep the conversation going on message boards?

Guy_incognito

So why did the sp go up 41% "out of the blue" on Thursday then? How did you short GDR by the way?

- You sound familiar. Do you have multiple names on here, TwoGood?

Bootnk19222.

So why did the sp go up 41% "out of the blue" on Thursday then? How did you short GDR by the way?

Possible any time now. 3 months since the application and IMHO the reason why the sp went up 41% last Thursday. Sell now and you could miss the sp doubling or more. RNS would no doubt be before the open and the mm's would put the ask price through the roof. You have been warned!

All IMHO.

Possible any time now. 3 months since the application and IMHO the reason why the sp went up 41% last Thursday. Sell now and you could miss the sp doubling or more. RNS would no doubt be before the open and the mm's would out the ask price through the roof.

All IMHO.

FDA approval soon? 41% rise in sp last13 Oct 2024 14:39

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.

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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.