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I’ve sent a few plus contact MW through LinkedIn but no response.
Need to know if the fda application is for class1 or 2.
When exactly was the de novo application submitted.
Have they been given a response date by fda or is it just an assumption. De novo process takes much longer than fda clearance.
What is the application number, we should be able to track it on the fda site, from what I have seen.
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 ?
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.
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 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.