Member Info for marik

Oh no. Not filtered, I'm devastated. I was given so many chances and now look at me... :(

Thanks for at least trying to educate us, perhaps you'll have better luck on Twitter or Parler or whatever...

Jon is a well respected scientist as is Mina, but the expert you are quoting thinks innova is the best thing since slice bread. Deeks mentions Avacta's first results as being good.

Hmm...

Jon Deeks and the MHRA and many others have qualifications that make them experts. Unfortunately, ndn as far as I'm aware you are not an expert.

The experts are the RSS, John Deeks, and the MHRA.

That's exactly my point. It's not Deek's or the MHRA who are to blame, it's the DHSC/PD/PHE/Gov who need to answer. Why put rubbish tests on the market and put red tape in the way of the good ones?

If I was a conspiracy theorist, which I'm not, I would have said the Gov has vested interest.

Agree with you @scardey_cat. The Innova test shouldn't have been given money by DHSC and the MHRA makes this clear when using the word "stretch". Jon Deeks agrees that the Innova test wasn't fit for testing asymptomatic people. The DHSC are belittling the MHRA process which puts public safety first.

It's not Deeks who needs the reviewing, it's DHSC, PHE and Porton Down and Mologic are willing to take legal action to get this realised.

If you read the full thread, this is the previous comment by JD which puts things into context:

https://twitter.com/deeksj/status/1404868939444854794

You can see it clearly relates to Innova and what he's saying is that false negatives and false positives do harm if not interpreted and acted on properly. Avacta doesn't have that problem.

However, relating to asymptomatic studies (1), Deeks et al., state we "are aware that several important studies in asymptomatic individuals have been reported since the close of our search" (1). For this reason JD, won't fully go on about Avacta until they've updated the research in their next iteration. However, if you want to see what he has to say provisionally about Avacta, he has tweeted:

"Good 1st results @avacta but make sure all studies are reported and peer reviewed so the evidence is clear to the world. @mologic are setting the standard..."

1. https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD013705.pub2/full

He's talking about the current tests that have been approved and tested. This goes back to my earlier post by Sheila Bird (pasted below for reference) who made the point that the CE mark that Innova was for symptomatic as opposed to asymptomatic people. However insisted on using it in Liverpool for the wrong purpose.

-------------------------
Innova deviated from its CE-use in the UK
-------------------------

I read this yesterday, but realised it may not have been posted here. In this post, Sheila Bird points out that Innova deviated from its CE-use.

Sheila Bird who is a member since January 2021 of PHE/NHS Test & Trace’s Testing Initiatives Evaluation Board and also member of the Royal Statistical Society’s COVID-19 Taskforce. She has summarised the main issues that we face with the Government testing process. It is clear that Innova are getting a free pass because there is no "harmonization on higher standards of diagnostic tests".

Instead we get Porton Down using frozen samples and stonewalling Mologic and DHSC awarding Innova contracts for which it is not CE marked for. Sheila interestingly points out that "the deployment of the Innova lateral flow antigen test for mass screening of **asymptomatic** people in Liverpool in November 2020 deviated from its CE-use, which was for people with **symptoms** of covid-19".

This indicates that Innova were fit for symptomatic testing, but certainly not fit for asymptomatic testing, but the UK Government went ahead anyway. Some have pointed out that Michael Mina is a strong advocate of LFTs, but he was also a strong supporter of the Innova Liverpool study which this article clearly points out was not the intended purpose of the CE mark.

https://blogs.bmj.com/bmj/2021/06/15/sheila-bird-diagnostic-tests-must-be-more-rigorously-regulated/
GLA.

I agree with you Larsh.

An acquisition sp of £2.80 is too small and very unlikely (Ray/Murphy). InfinisandBeyond is aiming for £12 and I would say on sale this will be well above that potentially 3x above. Whatever the case, the moment sales flow in, which is inevitable, Avacta will become an acquisition target with buyers paying a premium to take them out early before they become too big.

Sales are a given and it’s been two working days since EU CE marking. Being impatient won’t really make the process quicker, it just shows a lack of experience.

The UK is scaling to make 2m tests per day, Avacta capacity is scaling up to 30m per month (potentially more) and covid testing is running for years. That doesn't even consider Europe and RoW. Once the inevitable sales land, then £2-3Bn will be a small amount for an acquisition with the sp reflecting around £12 per share.

I forgot to mention that Sheila was formerly Programme Leader at the MRC Biostatistics Unit, Cambridge

I read this yesterday, but realised it may not have been posted here. In this post, Sheila Bird points out that Innova deviated from its CE-use.

Sheila Bird who is a member since January 2021 of PHE/NHS Test & Trace’s Testing Initiatives Evaluation Board and also member of the Royal Statistical Society’s COVID-19 Taskforce. She has summarised the main issues that we face with the Government testing process. It is clear that Innova are getting a free pass because there is no "harmonization on higher standards of diagnostic tests".

Instead we get Porton Down using frozen samples and stonewalling Mologic and DHSC awarding Innova contracts for which it is not CE marked for. Sheila interestingly points out that "the deployment of the Innova lateral flow antigen test for mass screening of **asymptomatic** people in Liverpool in November 2020 deviated from its CE-use, which was for people with **symptoms** of covid-19".

This indicates that Innova were fit for symptomatic testing, but certainly not fit for asymptomatic testing, but the UK Government went ahead anyway. Some have pointed out that Michael Mina is a strong advocate of LFTs, but he was also a strong supporter of the Innova Liverpool study which this article clearly points out was not the intended purpose of the CE mark.

https://blogs.bmj.com/bmj/2021/06/15/sheila-bird-diagnostic-tests-must-be-more-rigorously-regulated/
GLA.

Testing and Covid-19 are here to stay. Avacta capacity is in the several millions per month and could hit much higher. It’s been just over a week since MHRA CE marking and two working days for EU CE marking. After MHRA CE marking, Al Smith states “I am confident that the AffiDX® test will **now** play a significant part in this process”. This to me indicates that UK sales have been agreed and it’s a matter of time before the final signature. The same goes for EU sales.

The sales are inevitable whether announced this afternoon or later, but the moment they are announced, Avacta quickly targets a larger market cap. The ideal time for any company to be targeting Avacta for an acquisition is now when the price is lower ($10Bn) rather than later when it becomes a completely different beast.

I've been mulling this one over. Avacta sales will provide a significant revenue to drive the therapeutics division. However, it will put Avacta in to the mid to large cap status. In my view this places Avacta as an acquisition target. As an acquiring company, right now would be the time to start lining up the required funds and potential peripheral assets. Acquisition of BBI recently would be in keeping with Avacta as a second acquisition shortly after. The time frame for this would likely be in the coming few months, prior to Avacta becoming too big for acquisition, and I'm suspecting talks are already going on in the background. This is all IMO, but let's wait and see.

If Avacta release an RNS tomorrow re: sales, then great. However, if no news, then this distances Avacta from the Mologic issue. Along with the 21st June presentation just days away, I don't think it will be choppy for long. I'm fairly convinced that this is a UK order, I would prefer it to be a European one, but let's see.

I agree an RNS is in order, but it could be any day soon including tomorrow. I posted this earlier, as I feel this is a done deal for Avacta (IMO).

Mologic have had their CE mark since 24 December 2020 (1), but have been stonewalled by PHE (2). Mologic have helped Avacta with their CE mark in the UK. Post the UK specific CE marking, Alistair makes a statement (3), referencing "...helping our society and economy return to normal". What makes this specific to the UK is when he states (3): "AffiDX® test will now play a significant part in this process."

By using the phrase "will now" post CE marking in the UK, Alistair is specifically referring to the UK market. For that reason I think Avacta have received orders and it's a matter of time. Mologic may have seen this and become frustrated following 6 months since their CE mark.

1. https://mologic.co.uk/mologic-receives-ce-mark-approval-for-professional-use-covid-19-rapid-antigen-test/
2. https://www.telegraph.co.uk/business/2021/06/14/covid-test-maker-mologic-set-sue-government-stonewalling/
3. https://avacta.com/mhra-confirms-registration-of-avactas-affidx-sars-cov-2-antigen-lateral-flow-test/

The order is a matter of time. I would personally like to see European orders, but from Alistair's comments (see my post above), the UK deal is done.

Mologic have had their CE mark since 24 December 2020 (1), but have been stonewalled by PHE (2). Mologic have helped Avacta with their CE mark in the UK. Post the UK specific CE marking, Alistair makes a statement (3), referencing "...helping our society and economy return to normal". What makes this specific to the UK is when he states (3): "AffiDX® test will now play a significant part in this process."

By using the phrase "will now" post CE marking in the UK, Alistair is specifically referring to the UK market. For that reason I think Avacta have received orders and it's a matter of time. Mologic may have seen this and become frustrated following 6 months since their CE mark.

1. https://mologic.co.uk/mologic-receives-ce-mark-approval-for-professional-use-covid-19-rapid-antigen-test/
2. https://www.telegraph.co.uk/business/2021/06/14/covid-test-maker-mologic-set-sue-government-stonewalling/
3. https://avacta.com/mhra-confirms-registration-of-avactas-affidx-sars-cov-2-antigen-lateral-flow-test/

As many of you will remember, Al stated just last week that:

"Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX test will now play a significant part in this process."

That tells me that we are not facing the same issues as Mologic.