Member Info for EmeraldCarrots

So the De Novo request RNS is the next thing in the process. Hopefully not too long now. They have had 3 months to sort the request out after all. Then it's roughly 3 to 6 months before the approval. At that point I think GDR will be in a very good place with the Genedrive® MT-RNR1 kit. Looks as if all neonatal hospitals in the USA will need these machines. Not just one each either.

All IMHO.

So the De Novo request RNS is the next thing in the process. Hopefully not too long now. They have had 3 months to sort the request out after all.

I see. This "Breakthrough Device Designation" received from the U.S. FDA" speeds up the De Novo granting process.

That was of course back on 15th July which is now more than 3 months ago.

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

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

THAT IS WHAT IT SAYS!

"If the FDA grants a De Novo request:

The new device is authorized to be marketed and must be in compliance with applicable regulatory controls;

A new classification regulation for the device type is established;

The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type, when applicable;

The FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;

The FDA posts on its website a copy of the granting order notifying the requester we have granted marketing authorization; and

The FDA generates and publicly discloses a decision summary."

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

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request

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

Been applied for, that is what the RNS is about. Must admit the RNS is a bit unclear.

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

"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".

All IMHO.

One more time:-

I can't believe how posts here simply don't seem to understand the significance of this. FDA permission to sell the Genedrive MT-RNR1 in the USA that probably all neonatal units in the whole USA will have to buy. That is MASSIVE:-

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

All IMHO.

Hello.

I can't believe how posts here simply don't seem to understand the significance of this. FDA permission to sell the Genedrive MT-RNR1 in the USA that probably all neonatal units in the whole USA will have to buy. That is MASSIVE:-

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

All IMHO.

I hope!

Prospect of FDA clearance for a unique machine that probably all neonatal units in the whole USA will have to buy. That is MASSIVE:-

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

All IMHO.

If it is not true then you may lose a lot!

The sp surge. Prospect of FDA clearance for a unique machine that probably all neonatal units in the whole USA will have to buy. That is MASSIVE:-

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

Tomorrow. Pattern emerging here methinks. I day buy a shed load, next leave to settle, next day another shed load etc.... Tomorrow being the "buy a shed load".

Will see. Will be interesting.

Hello.

Researchers used the Parsortix® system to isolate and harvest CTCs from 38 localised and metastatic prostate cancer patients. CTCs were then analysed using a range of molecular techniques which enabled multiple biomarkers to be simultaneously analysed. The study demonstrated the highly effective capture of CTCs using the Parsortix system, with 67% of localised prostate cancer patients positive for CTC biomarker(s) at baseline and 77% positive for CTC biomarker(s) after treatment. The findings indicated a strong correlation between specific CTC biomarkers and clinical parameters, such as tumour grade and stage, suggesting that multi-marker CTC analysis could aid in risk stratification for patients. This adds to the body of evidence supporting ANGLE's large pharma strategy, highlighting the potential to inform patient selection for clinical trials in the development of targeted therapies.

So in a nut shell this could benefit participant selection in cancer drug trials. Then eventually could lead to the same test being used to test for suitable patients for a particular cancer drug. Potentially multi million revenue. Is very good news.

All IMHO.

LOL. Solicitor on standby.

Maybe.

Down 1.82%

??????

It's gearing up to push through 3p IMHO.