Member Info for Bobbyk

Thank you Mr Nugent for those encouraging words, especially as I purchased a further 420000 shares this morning!

Think Emerald meant to post on a different board!

I often wonder what the majority of about 50 staff fill their days with other than waiting for approvals and sales like the rest of us!

Wow do you live in a time machine!

I can get in ok

This is going to become a feeding frenzy like a tank full of piranhas who haven't eaten for a week as the shares get eaten up

Since starting the Breakthrough Designation program in 2015, the FDA has granted 933 devices Breakthrough Device Designation*. CDRH, the device division of the FDA, granted 921, while CBER, the biologics division of the FDA, granted 12*. The breakthrough device designation, however, does not guarantee FDA market authorization. Only 95 of the breakthrough designations have resulted in market authorization so far. Four of the 95 devices were reviewed by CBER. Of the remaining 91 devices, 32 received 510k clearance, 30 De Novo Classification Requests were granted, and 31 PMAs were approved*. Given the number of submissions received yearly, only 10-15% of De Novo and PMA submissions are also Breakthrough Devices. In contrast, only about 0.1% of 510k submissions are also Breakthrough Devices. The data for breakthrough device designation is only reported through December 31, 2023, but the projected number of breakthrough designations for FY 2024 (ending September 30, 2024) is 232.

Https://medicaldeviceacademy.com/breakthrough-device-designation/

With the lack of information forthcoming has GDR actually appointed a new CEO or have they just got the cheek to say they have!

A few months please!

I’m sure the momentum will pick up next week when many investors will be opening a new ISA for the year. Still well underwater here but confident all will come good when contracts and sales are announced , particularly when the funding issues are known. Add the stroke marker test to the equation and I think we will all be amazed the heights this will go to

Perhaps Budd is going to make a big announcement on his birthday tomorrow, although I doubt it. I don’t think he will be getting any birthday cards from investors but will be getting himself a very nice gift courtesy of our support for him. Oh well - perhaps I’ll be able to get a nice gift on my birthday next year when this all comes good
Here’s hoping

I think this is to test babies that are born deaf. Not those whose deafness is likely to be caused by the use of gentamicin. Different test altogether
https://www.nhs.uk/conditions/baby/newborn-screening/hearing-test/

https://apply.jobs.scot.nhs.uk/displayjob.aspx?jobid=110547&source=JobtrainRss

https://www.linkedin.com/company/hvd-vertriebs-gmbh?original_referer=https%3A%2F%2Fwww.google.com%2F

If you want to see what the whole process involves here it is
https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-diagnostics-guidance/Diagnostics-assessment-programme-manual.pdf

This probably shows a more accurate timeline but I’m sure much of it can be fast tracked
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-diagnostics-guidance/process-timeline

See attached document. Page 49 shows a timeline for the process although there is a fast track process which I hope Budd has applied for!
https://www.nice.org.uk/process/pmg19/resources/guide-to-the-processes-of-technology-appraisal-pdf-72286663351237

Yes very refreshing

A new report from the Royal College of Physicians and British Pharmacological Society joint working party considers the opportunities provided by increasing pharmacogenomic testing.

https://www.rcp.ac.uk/file/36426/download

This is an interesting report but if you don’t want to wade all the way through it there is mention of our test on page 33.
What is interesting is that an example outside of the neo natal setting is given. Imagine if GDR could ever expand their test for such cases. In the USA alone 4 million people a year are given 3 different types of Aminoglycosides antibiotics, including gentamicin which results in 40,000-200,000 people suffering hearing loss. Imagine saving the hearing of that many people on a world scale let alone the 114,000 babies around the world per year that could be saved from permanent hearing loss with the GDR test already being used, according to the Royal College of Physicians
Then there is the new product development programme which has been initiated for use of Genedrive® Point of Care device for stroke management in emergency care as mentioned in the interim report.
As an LTH I’m still well under water here but confident of exciting times ahead when the AIHL sales commence and further product development continues.