Member Info for Muck165

I’ve asked these

Do you still see India as a potential market for Genedrive and are Divoc the right partner?

You have said that our sales targets are aligned with Beckman’s Biomeki7 new installation targets. What are these targets?

What was the size of the first shipment to Beckman Coulter, and have any subsequent shipments been made?

Has the DHSC or any other U.K. government department expressed interest in Genedrive’s Covid tests and, if so, what confidence do you have in achieving sales to them?

How long can Genedrive continue selling its Covid tests in the US without an EUA?

Why do you think that sales of Genedrive Covid tests have been so poor to date?

In the November presentation you highlighted a potential sales contract with a European Ministry of Health. Can you update us on that please?

We are seeing more and more quality rapid antigen tests being validated and authorised. What impact do you think this is having, or will have, on the PCR market?

Does our association with Beckman Coulter give us any advantage at all with the FDA?

Beat me to it Reckoner

Also found this, which details the wider trials they are doing with 600 people.

On the plus side, it looks like this is being done in the US. That’s relevant because the FDA are keen for that to be the case.

On the down side, the trial isn’t expected to finish until the end of August! Still, until then Vatic are (I think) free to sell in the U.K. and Europe under the CE mark (at least for professional use), and can bid for U.K. tenders.

https://clinicaltrials.gov/ct2/show/NCT04733170

This share is not for the faint hearted. If you invest, be prepared to lose and don’t moan if you do. Nothing is guaranteed.

As Ive said, my money is on news which will hopefully propel us northwards. BC sales are somewhat out of our control, but there is massive potential and good news would be wonderful. The POC was signposted for launch in March, is entirely within our control, and I’ll be disappointed if we don’t get news on that before Thursday.

Hi AJ- I think Avacta needs to go on the list!

I see there’s a bit of chatter about the potential Sona link on Twitter. Personally I think we are their U.K. contract manufacturing partner, but it’s telling that neither we nor they have declared ANY sales since they CE marked in December.. I think it’s because it’s a brain tickler, which neither the U.K. or US (it got deprioritised for FDA approval) want. Sona have been working on a saliva version for a while, with news due soon, so that might be a different kettle of fish.

I’m in ABDX because of the low mcap, low free float, the massive current potential for all LFT manufacturers, our current capacity and ongoing scale up work, and because of the Avacta link. I also think we might be linked with Vatic, which could be a dark horse. I don’t think Sona is going anywhere at least in the short term and, whilst it would be great to get a nice contract to sell Abc19, I’m not holding my breath.

We will definitely get an RNS on Thursday to give the interim financial update, with the investor presentation to follow on Friday. If there are any price sensitive developments prior to Thursday then those would have to be disclosed via RNS promptly. In my view this would include details of any major sales or distribution contract (whether that be secured directly by GDR or though any of its existing distributors), POC CE mark/launch, or regulatory approvals.

I am betting that we we will get news before the interims are published.

Their saliva based test seems to have very similar specs to the Mologic test in terms of S&S and LOD, was CE marked in Jan, and they are currently piloting it with employers. It’s never been confirmed but in my opinion they are one of our 3 antigen tests (along with Sona and AVCT).

Worth keeping an eye on I think..

Hope so NE. The FDA granted just a single EUA last week, to a serology test. Odd. I’ve already posed a question though “investor meet” about the size of the first BC shipment, but whether it gets answered at or post the presentation is anyone’s guess.

There’s a DHSC webinar here, prepared this month, which explains the whole tender process. Might need to download it through the link.

https://atamis-1928.cloudforce.com/sfc/p/0O000000rwim/a/4J000000kIMf/UayhS3BfwlFEmGszDiOVpALeIy7bzyU5uphBDWdSEL4

Thanks

Here’s hoping for a good update today! - @cneighbour, can I ask who at the company told you we’d get one? Thx

Thanks Jim, really helpful.

So we might get them out at the same time as an update from the company.

Whoops!

https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

Here’s the CDC guidance on tests, referenced in your earlier post Rizvi1.

Here’s the CDC guidance referenced in the earlier link

https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

More details, with numbers, released today.

https://www.hhs.gov/about/news/2021/03/17/biden-administration-invest-more-than-12-billion-expand-covid-19-testing.html

There is a real focus on “screening tests” - $12.2bn, and FDA streamlining of the EUA process for them.

“ This week, the Food and Drug Administration (FDA) provided new recommendations and information for test developers to streamline the path to emergency use authorization (EUA) for screening tests. The recommendations apply to test developers who seek an EUA from the FDA for screening tests with serial testing. FDA may authorize certain tests, including those currently authorized for diagnosing COVID-19, for screening with serial testing prior to test developers conducting certain performance evaluations with asymptomatic individuals.”

Interesting, thanks NE.

I hope the FDA have been made aware that our test can be used in automated workflows for high throughput. May be that’s what this was;

https://fda.report/Company/Genedrive-Diagnostics-L-T-D

Although if it was I would’ve thought Proven Pharma would know if it was..

Anyone else finding it a bit odd that the FDA hasn’t granted an EUA to anything this week, whether it be a serology, antigen or molecular test. Don’t really know what to make of it given that, at least for Molecular, they rattle out EUA’s regularly.

Perhaps they’re diverting all effort into those tests which could assist the Biden plan, or is that just wishful thinking!

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen

Once again we have a little shake as we approach the 13.50 intraday auction...

Well, I’m getting dummy sell price of 134 at the mo, so looks like a tick up shortly

Presumably this.....?

https://www.dailymail.co.uk/news/article-9367495/French-experts-spot-Breton-Covid-variant-fully-evade-tests.html