Member Info for marik

For Avacta, the provisional S&S is expected at any time. It's better that Avacta confirms the numbers and validates the test prior to rushing to the market.

For those who are impatient and want Sir Al to rush things through, have a look at Sona Nanotech, where their share price went from $15 down to $1 (CAD) in four months where it stands now. In sterling, that's a value of £500M down to £30M.

"A highly scalable test device using readily available components and routine manufacturing processes has now been shown to have a sensitivity for coronavirus spike protein in laboratory samples better than 300 pg/ml which is in the range expected for spike protein in clinical samples."

> Although many are expecting more news, this statement from the RNS already speaks volumes. The test is able to detect within the expected clinical range, and a back of envelope calculation for the copy number confirms this. The core business of Avacta is affimers which have exceptional specificity and affinity. By default it will be an exceptional S and S.

> As Avacta has various arms including the covid-19 testing, pro-dox and platform. CV with S and S will confirm this and combined with the start of clinical stage therapeutics in early 2021, we can expect a mega re-rate in the near future.

In todays press briefing, Jonthan Van-Tam said that we won't be able to eradicate Covid-19 and will have to live with it forever. He made a point that Covid-19 could become seasonal. One of the reasons is the severity of the virus when co-infected with the seasonal flu. So although Covid-19 will be with us all year round, the impact will be greater during autumn/winter. During this period especially, the use of SNG001 will be critical for years to come.

The use of SNG001 in patients coinfected with other viruses (e.g. rhinovirus, influenza, adeno, RSV, parainfl. and coronavirus) has been touched on before in the COPD press release by Synairgen:
https://www.synairgen.com/wp-content/uploads/2020/09/200908-SG015-Press-Release-Final.pdf

Interactions between SARS-CoV-2 and influenza and the impact of coinfection on disease severity: a test negative design.
https://www.medrxiv.org/content/10.1101/2020.09.18.20189647v1.full.pdf

Co-infection in SARS-CoV-2 infected patients: where are influenza virus and rhinovirus/enterovirus?
https://onlinelibrary.wiley.com/doi/10.1002/jmv.25953

One additional very important question that wasn't asked at todays PM briefing: for how long does the vaccine protect?

Pfizer has announced efficacy data for 1 week post final job, BUT they have the data for 1 month and 2 months post jab. Pfizer will have supplied this data to the FDA, EMA and MHRA. What is the efficacy at 1 month and 2 months? Does it decay over time?

Pfizer and the other vaccine manufacturers have done well to produce a vaccine without cutting essential corners, bar the long term safety and the CMC. Both of which we will have to forgo for various reasons. The data generated is gigantic and is difficult to read and interpret. Both the FDA and EMA indicated that they would need time to assess the material (10th of December). In theory we should follow the EMA (until the Brexit transition of 31st December) and then approve via MHRA. Todays vaccine news throws up two questions:

- Why have we been able to approve the vaccine before the US and Europe?
- Oxford/AstraZeneca vaccine will most likely be delayed in the US and Europe. Are we about to override their concerns and approve it?

"One set of participants received two identical doses a month apart, while the other group received a half-dose, and then a full dose. The efficacy for the first, larger group was 62 per cent. In the second subgroup, it was 90 per cent."

Apart from the data being too small, any thoughts on why the lower dose resulted in higher efficacy?

https://www.ft.com/content/4583fbf8-b47c-4e78-8253-22efcfa4903a

Regarding: https://www.bmj.com/content/371/bmj.m4469?int_source=trendmd&int_medium=cpc&int_campaign=usage-042019

Shaun, the article is news coverage by the BMJ which refers back to the preliminary report by PHE & U. Oxford. The total number of tests taken (8774) should make the conclusion more reliable which is that these tests are not fit for purpose.

Innova also have a 5% kit failure rate, which is not bad, but not great either. The 30 minute wait between testing does not make it ideal for certain scenarios. The 95% sensitivity in those with high viral loads isn't a useful metric and should be ignored. Although the sensitivity varying by occupation/ training of the administrator is to be expected, it is interesting that this is by more than 20%, it also gives an indication for ease of use. The sensitivity should be taken as anywhere between 58% and 76.8% which implies that this test is unable to identify someone with the virus up to 42% of the time. To me that implies that this test is not fit for purpose, but has some use in other scenarios. I would agree with Prof. Jon Deeks view.

bump

Jakman, the reports are finally coming out regarding the AZ vaccine. What they've achieved is astounding, but the result is not as positive as the 90% initially suggested. There are issues with the other two vaccines as well and with time we'll become privy to the data. For reference I'll restate the points I made before:

> the fda required them both to submit two months of data post inoculation, which means they will have 2 months of data. Why did they just provide the first weeks data showing 95% and nothing at 1 month and 2 months? Do the benefits tail off?

> the placebo groups had lower than expected incidence of disease. Why was that? Can it be explained through volunteer bias?
e.g. more of those who are careful (socially distance, wear masks and practice hygiene) registered for the trial, if they are careful to begin with, could they have had a lower infection inoculant i.e. a less symptomatic infection.

> The vaccine trials were not designed to answer the question of whether the vaccine reduces viral shedding (spreading). What are the expected values?

> For those who did get infected, why did they? Were they of particular age group or other indications e.g. diabetes?

> The suggestion is that we continue wearing masks and socially distance even after getting vaccinated. How likely are we to return to normal?

Shaun, the article is news coverage by the BMJ which refers back to the preliminary report by PHE & U. Oxford. The total number of tests taken (8774) should make the conclusion more reliable which is that these tests are not fit for purpose.

Innova also have a 5% kit failure rate, which is not bad, but not great either. The 30 minute wait between testing does not make it ideal for certain scenarios. The 95% sensitivity in those with high viral loads isn't a useful metric and should be ignored. Although the sensitivity varying by occupation/ training of the administrator is to be expected, it is interesting that this is by more than 20%, it also gives an indication for ease of use. The sensitivity should be taken as anywhere between 58% and 76.8% which implies that this test is unable to identify someone with the virus up to 42% of the time. To me that implies that this test is not fit for purpose, but has some use in other scenarios. I would agree with Prof. Jon Deeks view.

As well as the points already raised about transportation / storage, viral shedding and problems with the AZ data, there are other things to consider.

Pfizer vaccine press release provided data at 1 week and not for the additional data at 1 month and 2 months. The >90% immunity is therefore to be taken with a pinch of salt until the 10th of December.

Pfizer lipid delivery is also an issue, which apparently they are working on to match Moderna. Which could be solved by next year. The shelf life is 6 months at -80, a few days in the fridge and 6 hours once reconstituted. For now assume that Moderna have achieved their goal and Pfizer being almost there.

Should all issues be resolved then Pfizer and Moderna together can supply enough doses for approx. 1.35bn people in 2021 i.e. 17% of the Worlds population. If transportation and volume was no obstacle, it would take a while to vaccinate 100's thousands of people per country per day, especially in the developing world.

If AZ data is rejected and/or we don't dramatically increase vaccine production, then there could be a big delay in returning back to normal.

The assumption on many of the BB and elsewhere is that now the vaccines are looking positive, on approval we could have the entire world vaccinated by April/May. The rate at which you would need to this would be staggering and in most countries without the infrastructure and storage facilities, this will be impossible in such a time frame. I've was trying to work out how long it would take to vaccinate 60-70% of the worlds population at a reasonable rate and I can't see that happening before this time next year. The bottleneck is on the vaccine volume production, storage and distribution.

I agree that testing will be required in the millions. The form of test required will most likely include those from the Novacyt portfolio.

Elsol, there were a number of issues with the AZ-Oxford trial. Their total participants was 20,000. There were 30 cases in the vaccinated and 101 in the control.

There was an accidental half-dose sent out to 2700 subjects that gave them the positive results at 90%. But, the remaining patients were at 62 percent effective. It's almost impossible to draw a reasonable conclusion from such a small subset especially when picking out an adverse signal. AZ didn't present their initial efficacy data clearly. Without more clarity, you would think that this could be 90% efficacy or it could be far less. I think there will be a lot of issues for approval, and the likelihood of AZ approval in the US will be much less than 95%. I'd be surprised if they get approval as it is and may require more work.

1. Synairgen is a covid stock, that's what they are doing right now, their COPD is on the back burner and their phase-3 covid trial is about to commence.

2. What Novacyt and Avacta have in common is that both their positive share price increases to some extent were influenced by Covid-19. Also on November 9th both dropped in price on news of vaccine.

Feel free to share this with other boards if it seems applicable.

We've recently had incredible scientific results from the Pfizer and Moderna vaccines has given many hope. For the financial markets, this has created volatility due to over reactive selling and buying. I originally looked at Synairgen as a case example of a covid-19 stock, but have sanitised it for Novacyt/ Avacta (didn't want to ramp) as my reasoning is applicable for others.

There are billions of people to immunise and even if we assume that all countries have the same infrastructure as the EU, US and UK to deliver (100’s of thousands jabs per day per country) and are as efficient in delivering the jab, we can’t get the vaccine rolled out before Aug-Sept 2021. Also note that the two vaccines, Pfizer and Moderna are likely to get approval, but AZ is unlikely (can discuss this later). Both Pfizer and Moderna can supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If each person needs two doses then the world will have a shortfall for around 6.5bn people. These manufacturing volume and distribution bottlenecks imply that realistically speaking, you can’t get 60-70% of the world vaccinated with 2 jabs per person before Oct-Nov 2021.

Pfizer vaccine press release provided data at 1 week and not for the additional data at 1 month and 2 months. This was picked up by an FDA advisory board member, who points out that the data was available but Pfizer decided not to submit it in their preliminary release. The >90% immunity is therefore to be taken with a pinch of salt.

Assume that the vaccines will reduce the virus shedding to zero, protect all age groups, co-morbidities and genders (which is highly unlikely), and all those immunised remain protected for a long period of time. Even then the expected numbers protected will be closer to 75% not >90%. Which means that testing will continue for at least the next 12 months and beyond.

GLA

We've recently had incredible scientific results from the Pfizer and Moderna vaccines has given many hope. For the financial markets, this has created volatility due to over reactive selling and buying. I originally looked at Synairgen as a case example of a covid-19 stock, but have sanitised it for Avacta (didn't want to ramp) as my reasoning is applicable for others.

There are billions of people to immunise and even if we assume that all countries have the same infrastructure as the EU, US and UK to deliver (100’s of thousands jabs per day per country) and are as efficient in delivering the jab, we can’t get the vaccine rolled out before Aug-Sept 2021. Also note that the two vaccines, Pfizer and Moderna are likely to get approval, but AZ is unlikely (can discuss this later). Both Pfizer and Moderna can supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If each person needs two doses then the world will have a shortfall for around 6.5bn people. These manufacturing volume and distribution bottlenecks imply that realistically speaking, you can’t get 60-70% of the world vaccinated with 2 jabs per person before Oct-Nov 2021.

Pfizer vaccine press release provided data at 1 week and not for the additional data at 1 month and 2 months. This was picked up by an FDA advisory board member, who points out that the data was available but Pfizer decided not to submit it in their preliminary release. The >90% immunity is therefore to be taken with a pinch of salt.

Assume that the vaccines will reduce the virus shedding to zero, protect all age groups, co-morbidities and genders (which is highly unlikely), and all those immunised remain protected for a long period of time. Even then the expected numbers protected will be closer to 75% not >90%. Which means that testing will continue for at least the next 12 months and beyond.

GLA

We've recently had incredible scientific results from the Pfizer and Moderna vaccines has given many hope. For the financial markets, this has created volatility due to over reactive selling and buying. Synairgen is case example of a covid-19 stock, but my reasoning is applicable for others as well.

SNG has a clinical trial about to start for phase 3, with positive covid-19 and COPD data for phase 2. Despite exceptional results from phase 2, SNG has been oversold heavily compared to other covid-19 stocks on vaccine news. The results from phase-2 covid trials were exceptional and the likelihood of the trial ending early is possible. The cost of the treatment at $3000 is low compared to hospitalisation costs. Vaccines although very positive have a multitude of issues.

There are billions of people to immunise and even if we assume that all countries have the same infrastructure as the EU, US and UK to deliver (100’s of thousands jabs per day per country) and are as efficient in delivering the jab, we can’t get the vaccine rolled out before Aug-Sept 2021. Also note that the two vaccines, Pfizer and Moderna are likely to get approval, but AZ is unlikely (can discuss this later). Both Pfizer and Moderna can supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. If each person needs two doses then the world will have a shortfall for around 6.5bn people. These manufacturing volume and distribution bottlenecks imply that realistically speaking, you can’t get 60-70% of the world vaccinated with 2 jabs per person before Oct-Nov 2021.

SNG phase 3 is expected to finish end of January, results and EUA/full authorisation will follow. In Feb/March, the SNG001 demand in developed countries will amount to 100,000 per WEEK. SNG are aiming for a manufacturing capacity of 100,000 per MONTH. However this number is expected to be 5 times this for the rest of the world.

Pfizer vaccine press release provided data at 1 week and not for the additional data at 1 month and 2 months. This was picked up by an FDA advisory board memeber, who points out that the data was available but Pfizer decided not to submit it in their preliminary release. The >90% immunity is therefore to be taken with a pinch of salt.

Assume that the vaccines will reduce the virus shedding to zero, protect all age groups, co-morbidities and genders (which is highly unlikely), and all those immunised remain protected for a long period of time. Even then the expected numbers protected will be closer to 75% not >90%. Which means that SNG001 will be continuously required at the rate of 50-100,000 per month well beyond the next 12 months.

As news flows out from SNG, Moderna, Pfizer over the next 6 weeks, expect the share price to shoot up. I’m making an assumption that on news of positive phase 3, the expected $300M revenues per month will take the share price to £4 per share. Following approval, I expect it to more than double.

GLA

HarChris, I'll respond to your disagreement of the £4 and £20 valuation in a new thread shortly. Also I'll give why Synairgen has been oversold along with many other covid-19 stocks (I'll post on their boards in due course).