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*initial

The schools testing programme will initially start with a pilot before scale up.

The definition of a clinical validation is use of the product in a clinical setting, which in the case of a self administered LFT would be in community settings, like schools...

Condor workflows make it clear this is a pathway on their website, so I wouldn't discount the idea that Validation could occur in the in total stages of the schools programme.

Speculation of course, but food for thought!

I’d agree this is likely good for us - Han**** was explicit yesterday that LFTs are pivotal to the governments plans going forwards.

Also, there’s two separate tenders, so SureScreen could pick one up for professional use and the other is cancelled ahead of an ‘at home’ roll out.

Finally Ophidian alludes to contracts being signed - from what I recall he has industry contacts at Porton Down, from which he correctly anticipated specification changes introduced by HMG in the summer - so fingers crossed!

Thanks Schrow.

What I find most curious is exactly *who* is undertaking the clinical validation and why is this not stated?

The August 6th RNS (BBI Appt) states:

"these clinical validation studies, which will be run within the UK government's CONDOR programme and potentially with other collaborators globally"

On August 7th it's announced by RNS that Liverpool School of Tropical Medicine will validate the test:

"Under the terms of the collaboration, LSTM will carry out the clinical validation of the Avacta COVID-19 antigen rapid saliva test in their category 3 laboratories on patient samples. In addition to working with the UK government's CONDOR programme to provide Avacta with access to patient samples in the UK, the partnership with LSTM also provides the opportunity to access patient samples in Africa and South America."

Yet the November RNS makes no mention of either CONDOR or LSTM - It simply states that 'clinical samples will be now be evaluated' without any further information of who or where this is happening.

As Lee says, it seems strange these partners are not even alluded to here, in stark contrast to the summer - so whats happened to them?

It's possible they have been omitted for brevity, but its a pretty crucial piece of information and we were promised a clear route to market.

Alternatively, as we now know from the updated testing protocol at the top of this thread, the futility testing at Porton Down includes preliminary clinical evaluation and would yield an indicative S/S.

And as we know from the recent tender pack, bidders needed to be enrolled in the futility testing ahead of the tender deadline to be eligible to tender - a process itself covered by a meaty NDA...

I suspect no details are given about the clinical evaluation because it's now taking place under the protocols for tendering, which cannot be disclosed, instead of with either CONDOR or LSTM.

Hey Robotics,

Thank you for you kind words.

An NDA would only cover the details of any discussions/contract with the government, including both the existence of those discussions and the NDA itself.

So there is not necessarily a contradiction between saying 'we have reached X milestone' and maintaining the terms of an NDA - IMO I am increasingly convinced it's why the last RNS is so woolly it barely makes sense.

Re-reading the RNS today, key statements are made without further details so that they almost contradict themselves - it feels like substantive pieces of information are missing that would link the document together; instead it just changes topic: an NDA would explain this.

I might be wrong, but we already have plenty of evidence the Government are fully aware of Avacta and I know we are *somewhere* in the validation process (I think Phase 2), so I think an NDA here is highly plausible, IMHO.

Regardless, I suppose we will find out - "shortly"...

Expansion of PCR testing at the Cambridge mega-lab

https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000kEoq/3hj.oOEhBaw3d1c3piwEgTcZrItYSvUqjRXSKDhkMRU

@Arnold - the tender process clearly stipulates an NDA, so if they have sent in tests for analysis, presumably that would be covered; which would explain the absence of any further information.

But the RNS makes clear that test performance is now being evaluated with clinical samples; ergo there is a test available for this process. Given its being set up for mass manufacture they can presumably churn out whatever number is required (500) with comparative ease - though presumably they haven't stated a design freeze in case clinical validation throws up issues.

@Arnold - Phases are in the attached government document; worth reading

I think they would RNS if in Phase 3, though possibly/probably covered by an NDA.

However, I also I understand the Oversight Group are saying the clinical validation hadn't completed as of last week - but given the small sample sizes presumably it cannot be far off at three weeks in...

Just noticed the page detailing the government procedure for LFT testing was recently updated on December 7th - would seem that SureScreen are in Phase 3 and we are in Phase 2.

From the last RNS:

"The performance of the test with clinical samples will now be evaluated as a precursor to a much larger clinical study with COVID-19 patients of known viral load to determine the clinical sensitivity of the test. "

https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices

From 15.38

https://www.bbc.co.uk/iplayer/live/bbcnews

Always conveniently omitted that Al’s new house caused a temporary drop in the share price which quickly recovered - it was the vaccine news which put the price on its arse.

Incidentally, FT has reported a massive increase in CEOs selling stakes owing to new capital gains tax rules likely to be introduced next year - another factor never discussed.

Its all getting tedious now - if people really believe the CEO is a crook, why be invested here? And if you’re not invested here, why obsessively post on this board?!

Sorry Wyndham - am in the dark like everyone else on that.

I think it’s realistic the tender has been delayed for the benefit of both SureScreen and Avacta given they both have similar production capacity vs the scale of Government demand. The third sovereign test - Mologic - I understand isn’t viewed favourably by the governments evaluation team ATM.

Have also reliably heard the Governments Evaluation have had sight of Avacta’s test, but that it’s still fairly early in the clinical validation stage - though data could come quickly.

So if I were to guess: the tender was first delayed to allow Avacta’s to complete Futility testing and now for SureScreen to complete clinical validation. SureScreen will thus get announced ahead of us and we will be announced later. But as I say, I am piecing things I know together here to construct a plausible view - and could be completely wrong!

The Government tender documents were posted here previously and clearly state that the only requirement to tender is the completion of the futility study at Porton Down - clinical validation can occur afterwards. Fully plausible we are in the tender.

Thing is though, given that RNS's are legally significant statements, for a lot of the claims in this thread to be true both Alistair and the highly experienced board of directors (Avacta isn't a one man show, regardless of how much Alistair is the face) would have had to knowingly sign off false statements and then submit them to their Nominated Advisor.

If these statement were indeed false and everything has, in fact, turned to **** - so badly the company is going to tank - I would suspect the chances of FCA involvement to be rather high, especially given the levels of frustration here.

So for the RNS's to be false, the board would have to acquiesce to the deception in full knowledge it would likely come back to bite them.

Personally, I don't see it.

There's delays, its very frustrating and the share price is going to be thrown around like a stock car until there's some positive news.

But the fact that neither Surescreen or Mologic have completed their clinical validation is indicative of the timescales involved here - we remain in the race, even if no longer winning it.

Fully appreciate why people are getting annoyed though...

November RNS:

"The performance of the test with clinical samples will now be evaluated as a precursor to a much larger clinical study with COVID-19 patients of known viral load to determine the clinical sensitivity of the test. In parallel BBI Solutions is working to finalise and validate the manufacturing process so that the Group can carry out a full clinical validation on the final product to support the regulatory approval process."

From this I would suggest the clinical samples are being applied at Porton Down while BBI finalize production and make any tweaks. I imagine we would be RNS'd at this point and then full clinical evaluation starts, but that's just my opinion.

@tallpaul - The message to bidders (you can find on twitter) says this is just a holding date and doesn't reflect a hard date for announcements; one isn't given (hence I say indefinitely)

@ditchit - I understand the evaluation teams have had sight of it but that "clinical validation isn't complete" - from which I have inferred it has then started, as per the RNS.

I don't know if we are very far along, but I am trying to find out; potentially significant (I'm speculating here) that the tender announcements have been pushed back indefinitely...

Hopefully not much longer now...

Okehurst - that isn't the case; Surescreen have almost completed validation at Porton Down, you can see their boxes in the pictures of Boris!!

It was Surescreen that Boris said he was excited by and sources for the article are directly involved in Government procurement: I strongly expect to see them awarded a contract soon.

I understand that Avacta have started their clinical validation process at Porton Down, so hopefully not much longer until we see some data...

"It has capacity to produce several million tests per week, with plans to expand further by the end of the year."