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Good timing! A good start to the day and I expect news if not the end of next week the following week and hopefully more RNSs soon after. I reckon we’re entering a news rich period. First off on our client Covid product testing and then possibly news on the real-time prototype now being tested on live virus then OEM deals etc. An exciting time indeed.

I’ve been invested here since Jan 2018 so most of the tenure and the turn around has been phenomenal. I look forward to the blog and the weeks and months ahead!

Thanks to you and your team!

You can’t deny the poor performance under the CEO’s tenure and it’s understandable why some want to see the back of him. That said, I feel the changes that have been made is not another false dawn. Time will tell but a more collaborative approach makes sense given the cost and difficulty of going it alone. The tech is clearly superb but the commercialisation and devising a sustainable business model lacking which means shareholder value can not be created/sustained which is of course a CEO’s primary objective. I’m looking forward and assuming this current turnaround (there have been a few) pans out how I expect I’ll continue supporting the co. Money was raised earlier this year at a massive discount with warrants because of the dire financial position the co was in but the new vision with lower costs, more collaboration and monitoring being key looks good so it’ll be interesting to see in Sept how much cash is left on the balance sheet and whether the co has reached cash flow BE and then can finally post a Q of profitability and not need a cash call for working capital.

Given the tech, the money spent on it and the current turnaround I think it’s the real-deal. Water scarcity and the need to manage it is only going to get more acute. Assuming the turnaround is working the current market cap of some £10m will hopefully be a thing of the past. The market rightly needs convincing so I hope to get some good H1 2020 commentary.

The financial results for 2019 are known and the new team came on board in 2020 so the FY19 audited results are really about the post YE commentary and hopefully we get a fair amount. Given the tardiness due to Covid and disposals I think they owe us some decent commentary on H1 2020. Let’s see.

Found by Wetdream on advfn. ICMRA COVID-19 Treatments and Clinical Trials Workshop #2 - Summary http://icmra.info/drupal/news/20july2020/summary

For hospitalized patients with moderate/severe COVID-19, it was agreed that there is a portfolio of options that can be considered suitable as primary endpoint to inform on the clinical benefit of investigational therapeutics for COVID-19 and that could support regulatory approval. Among these, time to recovery through D28/29, clinical status as improvement of 2 points on an ordinal scale (primary analysis using a proportional odds model, adjusting for baseline status and covariates), mortality within 28 days after randomization (especially for severe COVID-19) or time to sustained recovery up to day 90 (defined as alive and no relapse). While it was agreed that mortality is not the only acceptable primary endpoint, still it should be collected as a key secondary endpoint in all studies that don’t plan to use this outcome as primary. In the context of time to event endpoints, the way recorded deaths are handled should be discussed and clarified with regulators. For time to event endpoints, censoring deaths at D28 (or last timepoint in the window of investigation) as worst outcome was considered an acceptable approach, providing mortality is evaluated as a key secondary endpoint. Other endpoints that were discussed were: progression of disease, number of days not on ventilator from randomization to a specified timepoint, recovery rates. For endpoints based on proportional odds at a fixed timepoint, it remains to be discerned how to select the timepoint that would be mostly informative in capturing a treatment effect that would be clinically meaningful. For outpatients with mild COVID-19, it was agreed that mortality as the primary endpoint may not be suitable; rate of progression to severe disease, proportion of patients not hospitalized at a prespecified time point may be appropriate, depending on the primary objective of the study. It was felt warranted that objective criteria for disease progression should be included in the endpoint definition. Some endpoints such as rate of hospitalization are not considered objective enough as to be accepted. It was basically agreed that a virological endpoint could be useful for proof-of-concept studies, but primary endpoint for phase III clinical trials should be decided, reflecting the primary objective of the study. The evolving landscape of standard-of-care in the treatment of COVID-19 will need to be duly considered in the design of future studies.

Found by Wetdream on advfn. ICMRA COVID-19 Treatments and Clinical Trials Workshop #2 - Summary hTtp://icmra.info/drupal/news/20july2020/summary For hospitalized patients with moderate/severe COVID-19, it was agreed that there is a portfolio of options that can be considered suitable as primary endpoint to inform on the clinical benefit of investigational therapeutics for COVID-19 and that could support regulatory approval. Among these, time to recovery through D28/29, clinical status as improvement of 2 points on an ordinal scale (primary analysis using a proportional odds model, adjusting for baseline status and covariates), mortality within 28 days after randomization (especially for severe COVID-19) or time to sustained recovery up to day 90 (defined as alive and no relapse). While it was agreed that mortality is not the only acceptable primary endpoint, still it should be collected as a key secondary endpoint in all studies that don’t plan to use this outcome as primary. In the context of time to event endpoints, the way recorded deaths are handled should be discussed and clarified with regulators. For time to event endpoints, censoring deaths at D28 (or last timepoint in the window of investigation) as worst outcome was considered an acceptable approach, providing mortality is evaluated as a key secondary endpoint. Other endpoints that were discussed were: progression of disease, number of days not on ventilator from randomization to a specified timepoint, recovery rates. For endpoints based on proportional odds at a fixed timepoint, it remains to be discerned how to select the timepoint that would be mostly informative in capturing a treatment effect that would be clinically meaningful. For outpatients with mild COVID-19, it was agreed that mortality as the primary endpoint may not be suitable; rate of progression to severe disease, proportion of patients not hospitalized at a prespecified time point may be appropriate, depending on the primary objective of the study. It was felt warranted that objective criteria for disease progression should be included in the endpoint definition. Some endpoints such as rate of hospitalization are not considered objective enough as to be accepted. It was basically agreed that a virological endpoint could be useful for proof-of-concept studies, but primary endpoint for phase III clinical trials should be decided, reflecting the primary objective of the study. The evolving landscape of standard-of-care in the treatment of COVID-19 will need to be duly considered in the design of future studies.

Posted by wetdream On advfn and I’d suggest we tick all the boxes. Looks like very good news.

https://www.ema.europa.eu/en/news/global-regulatory-workshop-covid-19-therapeutics-2-agreement-acceptable-endpoints-clinical-trials

BBN on twitter -

https://twitter.com/bigbitenow/status/1288771538221764608?s=21

I'm still shocked by the lack of excitement around yesterday's update.

Just 2 months post therapeutic Affimer discovery, #AVCT have achieved a deal that will see an Affimer therapy taken through the clinic, without any cost to AVCT

Phase 1-3 costs alone = c. $37m

Not only that it is Covid related and so will receive added drive from Daewoong and expedited support from regulatory authorities.

If that weren't good enough, AVCT aren't merely receiving a royalty deal, they have a 45% stake in any outcome.

So that's c. $37m in costs + potentially pre-clinical, for another company to demonstrate the saety and efficacy of an entire AVCT platform, thus de-risking it across the board

Mr market appears to only want to know about the LFT.

However, by the end of this year, AVCT should have ;
1. An LFT and a BAMS test on the market.
2. Its Affimer platform fully tested for safety and efficacy in humans.
3. Be about to test its pre-CISION platform for safety and efficacy and a stab at a min. $1BN pro-doxorubicin market.

Now the LFT could well create enormous revenues but de-risking the Affimer platform and/or the pre-CISION, is at least equal if not greater than that.
Plus, all the cash flows that BAMS and the LFT create, can drive even greater expansion of those platforms, if they indeed become more de-risked.

Dilution free.

pre-CISION alone has a further 9 known candidates.

I appreciate fully that the LFT is a big front end goal but I also believe strongly that many investors are selling themselves short, by not bothering to learn the AVCT story properly.

A reality that demonstrates itself clearly through this whole too late to market theory, for the LFT.

The greatest investment is time itself.

My sentiments exactly, lunsam.

https://www.thetelegraphandargus.co.uk/news/18602487.amp/

Love this as it’s 83% (5 of 6) improvement -
“So far we have recruited six patients to the study; five of whom responded very well and improved quickly. The patients were all in the early stages of Covid-19 and were at risk of developing severe disease which could require ventilation.”
This is great and these kind of personal at stories will surely help our case for fast track validation and get us in other countries like Brazil, India and the US.

Eddie Imishue, 55, is a Mental Health Care Support Worker with Bradford District Care NHS Foundation Trust.
On April 18, he was admitted to the BRI with Covid-19.
He was prescribed the drug SNG001 via nebuliser to stop his symptoms worsening and prevent the need for being placed on ventilation.
Mr Imishue said: “I was very breathless and had a persistent cough. I also felt very lethargic. When I tested positive for Covid-19, I was asked by Dr Saralaya if I was willing to take part in the treatment trial and I said yes.
“The treatment had a profound positive effect on me and my symptoms improved so that I was able to go home, where I continued with the treatment.

Leonard Licht, Chairman of Hg Capital

Mark Brewer, analyst at house broker FinnCap, said the potential sales of Synairgen’s drug, should it attain regulatory approval, could dwarf the compay’s market capitalisation, which even after the shares’ surge today stands at £314m.

‘It is within the realms of possibility that Synairgen will receive orders from governments ahead of the winter flu season and potential second wave of Covid-19 infections,’ he said.

Based on pricing points for [potential Covid-19 treatments] Rebif and Avonex and Gilead’s remdesivir ($2-3,000 per treatment) and the prospect of Synairgen being able to supply up to 1m doses by the end of 2020, it is not inconceivable that an order book of $2-3bn could be generated by the year-end,’ he said.Based on pricing points for [potential Covid-19 treatments] Rebif and Avonex and Gilead’s remdesivir ($2-3,000 per treatment) and the prospect of Synairgen being able to supply up to 1m doses by the end of 2020, it is not inconceivable that an order book of $2-3bn could be generated by the year-end,’ he said.

Yet again another super post.

https://en.calameo.com/read/006113385393912394987?page=8

A really well written piece and goes to show what meaningful collaboration can bring. A genuine game changer like our POC will be.

https://www.labskin.co.uk/the-mission-to-detect-covid-in-real-time-in-wastewater/

https://www.labskin.co.uk/the-mission-to-detect-covid-in-real-time-in-wastewater/

https://www.labskin.co.uk/the-mission-to-detect-covid-in-real-time-in-wastewater/

https://twitter.com/bigbitenow/status/1284040532944203777?s=21

I'm certainly in the long term Covid testing camp.

People playing the vaccine eradicates testing card, are for me misunderstanding the ability and chances of a vaccine, delivering sufficient efficacy, to protect a population.

A successful vaccine must achieve c. 70% herd immunity in the total population.

The chances are that a significant portion of the population will refuse the vaccine.

Therefore, the vaccine has to be better than 70% efficacy to achieve its original goal in total population

Approx 10% of all vaccines that enter clinical trials, are eventually licensed. That does not mean they then go on to meet the herd immunity target.

The Oxford trial currently being promoted as the lead candidate
has to have one heck of a run to beat that 1 in 10 percentage. Even then its got to beat all flu vaccine performances, seen over the last decade (best being 60% efficacy), to meet the target.

Anything short of that and we are looking at ongoing testing on a long term basis if they indeed achieve their goal and I truly do wish them well with it, then we still have the problem of vulnerable people (generally over 70s, low immune systems), requiring added measures (tests) because their immune systems generally don't accept vaccines that well.

That aside, and assuming the very first vaccine candidate does indeed hit its 70% herd immunity requirement and the whole world population is keen to take it, it still has to be produced and distributed.

A logistical nightmare.

Plus what is advertised in the UK, isn't the reality in the rest of the world.

The Oxford team talk up Sept (which is dangerous) but the lead scientist of their S.A. trial, is talking best case vaccine results by end of November.

That's not regulatory approved, distributed and herd immunity achieved.

I'll park my thoughts on the lower middle income countries that will likely never see a vaccine or will be years down the line.

However, long term testing that is easy to use and deploy is going to have a place in this world, so long as Covid has the ability to inflict such strong affects on our health.

Treatments will no doubt reduce world concerns but in order to treat, we must first of all test.

Best/cheapest tests should do well for a long time to come.

One other important point.

If said vaccine is indeed deployed, whatever its efficacy, given the limited analysis conducted on it to date, it would be a reckless government, that did not continuously test in order to monitor its effectiveness.

The lower the front end efficacy, the more testing will have to be employed, until such time the vaccine's effectiveness is properly established.

The idea that a rapidly produced vaccine would immediately become the sole front line protective measure, is for me just absurd.

FDA approval is pushing it. We don’t even have a prototype! If as good as we hope it’ll be fast tracked but let’s just chill. Great to see the rise and hopefully all day as FOMO kicks in and a 5pm RNS so media all weekend and whoosh on Monday from a higher base.