Member Info for tqhussain

IMO, they will have to raise but it will be far easier if they have FDA approval. They will need revenues of ~8m to breakeven.

Anyone know what’s the 510(k) submission number? I was trying to find Cardio Incode on the FDA site but no luck.

Has anyone managed to communicate with the company ?

By my maths, we have enough cash until sept/oct.

We can’t afford any hiccups with the fda/de novo approval. If we can get the approval in the next few week then I can see this self sustaining business very quickly.

I have faith it will come good too but MW has to provide more frequent updates or at least do more PR.

This is a revenue generating business with an increasing work force so I expect more news on deals/collaboration/expansion.

Must*

There much be updates for Lipid incode. De novo approval is for cardio incode

Pretty poor PR and zero response from the company to my emails/messages. Feels like the MC is tracking the daily decrease in cash position lol.

Https://wssn-ng.com/Ltd/about-us/

Wow, this looks silly cheap now for a highly profitable gold producer and lithium explorer.

Don't forget the Glanaco business. Bought for 1.2m euros, if I remember correctly, and then sold back to the same owners for 1 euro. One of the Fitzgerald's worked for MW and now works at Glanaco. I am confident this was another orchestrated transaction for the benefit of GB's friends & family.

Article from last year but it just highlights that potential here.

https://www.itv.com/news/2023-07-14/genetic-testing-could-bring-in-new-age-of-diagnostics-in-nhs

Agree, poor communication. I have emailed and messaged the company a few times but never get a reply.

If they get the De Novo approval then cash burn will not be an issue IMO. Revenues from the USA market should be quite meaningful. I think one more raise is a high possibility by the end of the year.

I hold just over 170k shares. I will wait for news before I decide to add more.

On a balanced view, Cash burn is high so sales will be important to offset the increasing costs.

Got my last buy in now. Fingers crossed it comes good for us all.

Agree with Swiss, I am expecting an outcome in Q2, Q1 is being very optimistic IMO.

Sales today are mainly driven by LIPID, which it gaining more and more attraction but CIC approval for the US market will be the bid one!

I have to say it was very odd to hear, considering it was a UK listed business.

I have reported it to the FCA, even called them up and I was told DVRG is not regulated by the FCA.

Https://sterlingmedicaldevices.com/thought-leadership/is-the-fda-de-novo-pathway-the-right-medical-device-regulatory-pathway-for-you/#:~:text=The%20De%20Novo%20pathway%2C%20introduced,predicate%2C%20or%20no%20substantial%20equivalence.

Https://healthinnovationnenc.org.uk/what-we-do/improving-population-health/cardiovascular-disease-prevention/familial-hypercholesterolaemia-fh/

Lipid inCode® is the first commercial polygenic test for CVD to be implemented by the NHS. Read about how the AHSN NENC will now implement the use of the test in the Darlington PCN and community practice representing over 100,000 patients in the North of England.

If they manage revenue of £1.8m for 2023, I'll be very happy with that.

2024 revenue should be double that if things go to plan.