Member Info for Da-Doo-Ron-Ron

With the prospect of news coming ‘soon’, ‘shortly’ or ‘in the near future’ I’ve kept a daily journal since the placing in June in a Disappointments Diary I was given last Christmas. In anticipation of the much vaunted inflexion points each entry records Avacta’s sp and RNS news. Little ink was spent on the latter.

I’m a LTH as I have confidence in the company, its management team and the Affimer IP. The diary’s weekly quips however, such as ‘No news is increasingly worrying’, ‘If at first you don’t succeed get used to it’ or ‘When the going gets tough, tough’ have introduced moments of doubt exacerbated by the recent plunge.

I just hope my relatives give me a more positive present this Christmas.

Is there a weighting to favour UK companies to help build a sovereign diagnostics industry sorely needed in a post Brexit world? Or might the government once again order LFTs made in China?

Does anyone know the current utilisation of the mass spectrometry machines? If there are 200 hospitals in the UK with a MS machine able to conduct 1000 tests per day if wholly assigned to COVID-19 how much of that capacity is already committed and what for? If they are currently at 90% utilisation for non CV assessments then there’s little capacity left for the Adeptrix/Avacta assay unless lower priority testing can be reassigned.

Could the fee to a ‘Service Provider’ relate to MEDUSA19 and the possible termination of the legal agreement giving them exclusive global rights to sell to the consumer? Since it seems that all available production capacity will be allocated to the UK government there will be nothing left for the Boohoo boys and the contract could severely limit Avacta’s ability to negotiate royalty agreements when offering Affimers to a worldwide customer base.
Just thinking out loud.

Question 1:
When can we expect to receive CE and FDA regulatory approval for the LFT and BAMS tests for COVID-19? Please give an estimated date not ‘soon’ or any of its other variants.
Question 2:
Has our involvement with the Condor programme helped or hindered our speed to market?

Or will an RNS will drop this week to provide the answers?

As shareholders we own the company. Our role is to support the highly talented, professional and dedicated management team and their staff as indeed we have through substantial investment including the recent placing. Bearing in mind that this global pandemic is resulting in huge loss of life it is not unreasonable for us to ask for precise information unfettered by political restraints regarding progress with regulatory CE and FDA approval. Not ‘soon’, ‘shortly’ or ‘in the near future’ but by when.

This news must have a significant bearing on the Moonshot and the roll out of Avacta’s LFD rapid antigen test. If retail, sport and hospitality venues will be displaying posters with QR codes readable by a smartphone to link with the test and trace system from 24th September the next step surely would be to allow access with free movement without social distancing to those with a clear LFD test. The test could be either a physical test on entry or a fast track process for those presenting a proven clear result on their phone arising from the AffiDX process.

It’s my wife’s birthday on 24th September. I normally buy her a new broom as a birthday present but do you think there might be the long promised inflexion point before then because I might lash out on a new steam iron?

Was anyone watching the Victoria Derbyshire programme a few minutes ago? I think there was a reference to Matt Han**** proposing a day pass for a pregnancy style test which would allow access to theatres and sports venues on the day of the test. I only heard the audio in the background so was that right?

I’m not surprised that government ministers have been reluctant to speak on R4. Matt Han**** was constantly interrupted by Nick Robinson and had little opportunity to explain the new testing technologies under consideration and the policy for their implementation.
Surely the purpose of a radio interview is to derive knowledge for the listener rather than be a platform for the interviewer to bully the speaker into submission?
We live in unprecedented times so we need a national effort to save lives and restore the economy. Journalists have a positive role to play in achieving that end.

The webinar panel discussion on 17th June between Klaus and David included Brendan O’Farrell, the CEO of DCN Diagnostics. Could DCN be a manufacturing partner in the US?

According to their web site “DCN Dx operates a full scale, flexible manufacturing program under our ISO 9001:2015 and EN13485:2016-certified quality system. Our contract manufacturing capability includes batch and reel-to-reel manufacturing lines housed in an environmentally controlled facility with dry rooms for lamination and assembly. Our system is set up to be flexible and scalable, so whether you require production of a few thousand units or a few million units, DCN Dx can respond to your requirements.“

As students return to full time education there is a clear need for every school and every University hall of residence / Faculty to be fitted with Deep Verge’s RAWTest platform to detect COVID-19. Will the evaluation by the University of Aberdeen be sufficient to warrant a large government order or would it need acceptance and approval by the Condor programme? Clearly there’s a whole range of premises beyond education - cruise liners, offices, factories, stadia, military establishments etc that would benefit from early alerts to infection but what is the process of regulatory approval which would release a tsunami of orders and benefit society at large? Would it be feasible for building regs to require all buildings with 50+ occupants to immediately install an early warning system to test wastewater and report the results daily to the local Public Health authority?

The U-turn by the US Centres for Disease Control and Prevention on Covid-19 testing guidelines has raised eyebrows in the scientific community.

The agency no longer recommends testing for most people without symptoms, even if they have been in close contact with an infected person. Previously it said tests were appropriate for anybody who had reason to believe they had been exposed.

Experts warn that extensive testing is vital to contract tracing efforts, and controlling the spread of the virus. Some studies suggest that about half of all transmission is from people who have yet to develop symptoms.

However, the new guidance is no different to that in place in the UK. Under the NHS test and trace scheme, people who have been in contact with an infected person are advised to self-isolate for 14 days. A test is only deemed necessary if they develop symptoms. The rationale is that a single test will not definitely prove you are clear of the virus if you are in the early stages of infection, so it is better to wait until there is hard evidence that you are falling ill. Health Secretary Matt Han**** has suggested asymptomatic people may be tested later in the year if new rapid turn-around tests come on stream.

Do I detect a note of irritation in this morning’s RNS about Medusa’s antibody test?
I makes me wonder whether the release of the updated draft web site was designed to put pressure on Avacta In two respects - Medusa are losing patience with the slow pace of regulatory approval and fear that the government will take all available stock leaving them with nothing to sell. Hence the implied threat of another supplier of an antibody test with high sensitivity and body copy that will confuse the average consumer into thinking it is of comparable standard. Which it isnt!

Yes why sell one test when you can get double the sales revenue from two? Do you want the ‘Have I got it test.’ or the ‘Have I had it test’? Or both?

If the UK government is planning to take the lion’s share of BBI’s production capacity perhaps Medusa will have to offer other tests as well as Avacta?

What I’m struggling to understand is why it’s taking so long to assess the Adeptrix assay when each BAMS machine has an output of 1,000 tests per day and it can be calibrated against the NHS test with a daily capacity of 200,000. Is the problem scientific, administrative or political?

My investment ratio AVCT:SKIN:MWG is 100:4:2. Does that sound about right?

Difficult though it is to believe, the ADVFN Avacta board is even worse!

If Avacta’s LFT is to play a role in monitoring the the health of children there are only a few weeks before schools open in early September. There probably isn’t enough time to manufacture and distribute stock to 32k schools with 10m pupils let alone supply care homes as promised and hospitals. So could today’s news be the creation of additional testing capacity to preempt further criticism of government policy?