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Terewok, for me, the ICMR and FDA EUA approvals will be the foundation for establishing the RT-PCR Covid test for GDR and are crucial for the short term recovery of the SP from where it is today. With ICMR approval I do expect significant sales to be generated relatively quickly as LHGP/DIVOC partnership have been working on the India business opportunity for some time so should be 'ready to go' as soon as approval is received. The FDA EUA, when it comes, will further drive the SP and I am hopeful that the 'interest' shown by potential US partners will also transfer relatively quickly into significant sales, not least because of the way Covid-19 is spreading in the US and their need for more testing.

So it is important that those two areas are established with sales pipelines open and operating, then other milestones, such as WHO or Africa country approvals, will add further support to the SP.

How quickly these approvals and prospects can be converted into sales, plus the extent of those sales, will drive where the SP will settle over the next few weeks. However, I deliberately do not give SP predictions, all I will say is that my investment is showing a paper loss at the moment but I have no doubt that significant RT-PCR test sales will come and my paper loss will be turned into significant profit, hence why I still remain invested here.

All the above is not even considering the opportunities within the NHS for the RT-PCR test and upcoming POC test as we know that DB is engaged with DHSC about these tests. Some scientists expect there will be a 2nd Covid wave hitting the UK in the autumn/winter months ahead, so the opportunity to get into the UK market with a 'top tier' test has not gone away. Also, we must not forget the the AIHL product sales opportunities which I believe will have a very good market in the UK/EU, as well as the US.

Let me try that again.......I do expect WHO approval to take longer though than FDA EUA.

The WHO approval status (updated today) hasn't changed since the 8th July, still 'awaiting submission' for both Dossier and Quality Assessment. I do expect WHO approval that to take longer though then FDA EUA.

I think the 360DX list can be a little incorrect or out-of-date.

The term 'remains under consideration by the FDA' used in the RNS seems to be very deliberate. Does it mean that the FDA now has all the validation submission data and is now going through it before the final thumbs up/down? We may soon find out. I think the 360DX list can be a little incorrect or out-of-date.

Wiggly, you're right, Klaus/Cytiva did not agree to use the term 'very confident' in the RNS. If you want to make quotes from an RNS, then please quote accurately please.

Gtting additional CE Marking is a normal process followed by many companies to ensure their test is opened up to the widest customer base, particularly of course in Europe. According to Genedrive ......

"It’s very unlikely a customers will run the test if it isn’t CE marked or otherwise approved for their machine. Customer will ALWAYS validate ANY diagnostic test themselves, even if it is CE marked. It’s generally a lab accreditation requirement. The performance of the various PCR platforms in the market is not identical, so the performance of the test is not identical. You will see many companies provide performance data by platform for this reason."

So although the Roche Lightcycler 480 II is a very common PCR machine, it makes total sense to keep opening up the opportunities to customers who may use the ABI 7500 FAST and BioRad CFX96 systems. The fact that even if it is CE marked potential customers will still need to go through their own validation cycle within their own labs, goes some way to explain the length of the time it takes to get to first sales from potential customers.

I had one or two questions on the new Exporter tool, inlcuding if it is actually needed by customers, so I asked Genedrive to clarify. Here is the response I received.....

"It's free and downloaded with a code from our website. It is not mandatory to use but made available as an accessory. It’s much better that the basic software on the PCR machines and we expect most people would want to use it."

So, it was not something that was deliberately 'hidden', or kept secret from earlier sight as being something that was needed to make the test work, it was simply a great idea to further differentiate the better 'simplicity and useability' of the GDR test from others.

"The new Exporter software doesn’t actually run "on" these PCR machines. It just accept the data from them, and so the Exporter sits on any separate PC in the lab, or indeed on the PC for the PCR machine. It needs to be configured for each of the different instrument types as their output files are different formats, and their lasers and detectors they use drive different data ranges. The threshold values to do the interpretation (pos/neg) are derived by running clinical specimens of known type and calibrating the interpretation algorithm."

TB, I know that validation testing is complete and I previously reported that to this BB.

Have never been out....

Disappointment today.....but it can quickly change because the company confidently expects to be 'delivering successful commercial outcomes in the near future', no doubt driven by the ICMR and FDA EUA approvals, which although both have been too long coming, when they do arrive will be the immediate catalysts to drive the all important first significant sales of the PCR test.

So I will patiently wait for the near term........

I have only just been able to catch up on this BB today as have been far too busy this week with 'work'. Can I express my thanks and appreciation to all those who have added new and valuable contributions to the GDR story today, great team work all round.

ST and technick, yes, the links between DIVOC, LHGP, GHIF and Genedrive have been discussed, confirmed and posted before.
I divulged too much previously so not able to get further updates unfortunately. Patience is key, still sipping my guinness....

There is a link between Global Health Investment Fund (GHIF), who now own 13.66% of Genedrive shares, and Dr Kanav Kahol who recently set up DIVOC in India, going as far back as 2013......

https://norad.no/en/aktuelt/arrangementskalender/2013/new-partnerships-for-innovation-in-global-health/

Dr Kanav Kahol was from the Public Health Foundation of India at that time. So it doesn't seem to be a a recent 'link up' but something that has likely grown from deeper connections......

At a non-technical 'helicopter level', for the Avacta POC LFT test, the risks and potential impacts in my mind (so imho) are :

1. Avacta, cannot deliver a working product - very low risk on the basis the AS has stated they have a working prototype. On that basis, an LFT should be delivered by the company. High negative impact if the risk materializes, but unlikely in my view.
2. It will not have the level of performance of Sona or other competitor tests - medium/high risk, because nobody knows what the level of performance the Avacta test will reach yet. Low impact because the Avacta test can still be very successful as long as it meets MHRA requirements. AS does seem confident of beating the minimum requirements.
3. It will take longer to pass all validation tests, since it is designed to be taken by a layperson - medium risk on the expectation that anything meant for use by a layperson will have more 'hoops' to jump through. Mitigated to some extent by working with the authorities. Impact is low, as mass screening does need this type of test and if it is delivered in the next market 2-3 months (likely). Any longer than that then impact may rise a little.
4. They cannot manufacture enough to meet demand - medium risk in the short term, but likely reducing over the intermediate term as manufacturing can be scaled up with more partners. Impact low, if Avacta sells all that can be made it will still be good for the SP and will improve over time.
5. More LFT competition arrives - medium risk, as I know of at least 2 other POC LFT antigen tests under development within the boundaries of the UK. Impact, low-medium, as long as Avacta's test meets MHRA requirements (very likely) then there is room in the market for all successful tests.
6. The Covid pandemic subsides - low risk through the next 6-9 months at least, you only have to see the resurgence in some countries and others that haven't even got through the 1st wave yet. Then winter may make matters even worse. Impact would be high but I think this is an unlikely scenario for the next 12 months.
7. A working vaccine is developed - associated with risk no. 6 above. Low risk within the next 6-9 months, probably longer because it does take time to make a safe working vaccine, even when all normal processes are expedited. You cannot short-cut 'safety'. Impact would be high but I think this is an unlikely scenario for the next 12 months.

If you believe risk 1, is low risk (which I do) then an investment in Avacta in the short to intermediate term at least should prove to be a good one.

Safy, it was confirmed to me by Lions Head Global Partners they are legit when I asked them about DIVOC's direct partnership reference to LHGP on the DIVOC website. No harm in getting it re-confirmed again by Genedrive though.

I have still asked if the John Rylands comment is authentic, you never know! I may not get a response though.

Lol! you've got comments from David Budd and Bill Gates now, with odd time stamps! So no doubt a mickey take!

scart, perhaps a question for Walbrook PR, investor relations tomorrow?

Newbie111, I am in email exchange with a stakeholder whose team have been directly involved in this process (not Genedrive). I previously reported that they were delayed because the India Govt testing machine broke. Take it, or leave it but I only report from credible sources and facts.

This is the latest information I have on India approval progress....

- the validation testing is complete
- the docs are with Drug Controller General of India (DCGI) now
- but then the DCGI closed for a 2 day deep clean after a group of employees got covid!

So timing is in the hands of the Indians right now, but logic would suggest that it is imminent (bar anymore Covid!)