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It is a typo Robs. Check out the original transcript issued by Hess. Thanks, Celtics
I thought it might be useful to repost some of the Q&A from the 28th September InvestorMeet presentation following the recent commentary on UK rapid testing (FT article) and project planning tender awarded to PA consulting.
It cannot be clearer that Avacta is very much part of the UK Diagnostic Project.
Q12: Have you been approached by Governments other than the UK regarding supply of the rapid antigen test?
o Avacta regards all discussions with authorities, healthcare providers and other third parties as strictly confidential. OUR MAIN FOCUS AT THE PRESENT TIME, GIVEN THE SCALE OF THE DEMAND, IS THE UK.
Q22: Assuming that pilot production issues and/or clinical validation are the delay in bringing the product to market, what mitigations are being made to shorten the process to be able to mass produce the final product and do the current agreements with manufacturers BBI and Abingdon ensure that capacity is guaranteed?
o As part of any product development process, the potential for delays at all stages require mitigation steps to be planned so that they can be put in place if required. Avacta has worked tirelessly with its publicly-announced partners, and is working on other projects that are not in the public domain, to ensure in so far as is possible that the Company generates revenue from its SARS-CoV-2 binding Affimer® reagents as soon as possible. IN PARTICULAR THE SCALE-UP OF MANUFACTURING TO MEET THE ANTICIPATED DEMAND IS SOMETHING THAT AVACTA HAS WORKED ON WITH ITS PARTNERS, AND OTHERS, FOR SOME TIME NOW. Further information cannot be disclosed at this time because of commercial confidentiality but PROGRESS IS BEING MADE IN EXPANDING THE AVAILABLE CAPACITY TO AVACTA IN THE UK AS WELL AS CONTINUING TO REVIEW POTENTIAL OVERSEAS MANUFACTURERS.
Q24: How will you overcome manufacture scale up challenges of the LFT?
o Working with multiple manufacturing partners is the only way in which the anticipated scale up challenges can be met. AVACTA IS INITIALLY FOCUSING ON UK MANUFACTURING PARTNERS, AND IS SUPPORTING THEM IN THEIR SCALE-UP ACTIVITIES, AND IS ALSO IN DISCUSSION WITH OVERSEAS MANUFACTURERS WHO CAN BE BROUGHT ON STREAM IN DUE COURSE.
thanks,
Celtics.
Hi Tomy - Notice to Mariners 82 in 2020. 9th December 2020.
thanks,
Celtics.
One test from the 8 that passed Phase 3a has been omitted or could be an error in the PHE document.
Recall the Director's Talk interview with Alistair on Astrea Bioseparations @ 5 mins.
"As we go into the Christmas period, I can tell you that I am very happy indeed with the performance of the test, so we’re now moving into clinical testing in parallel with the manufacturing scale up and the clinical testing is critical of course. We know that we have a very good test as far as the laboratory performance is concerned using spiked nasal swab samples from healthy volunteers and we’re now in a position to see how that translates INTO REAL PATIENT SAMPLES IN THE CLINICAL SETTING".
Phase 3a is at the Porton Down (laboratory) NOT in the Clinical setting. I am speculating only, but I suspect Avacta had passed Phase 3a in December and is currently in Phase 3b which is "Community research evaluation". Completion of Phase 3a (Porton Down laboratory testing) is not Price sensitive info in my opinion.
thanks,
Celtics.
https://www.medrxiv.org/content/10.1101/2021.01.13.21249563v1
This was released and discussed on the board recently.
Possibly, I am missing something simple and I apologize if that's the case, however according to line 171 "Eight LFDs have passed Phase 3a evaluation", yet only 7 tests are explicitly disclosed within that section (with LFD x being one of 7), so; Innova, Orient Gene, Deepblue, Fortress, Roche SD Bio, Surescreen and LFD x , and separately in the Supplementary material only 7 tests listed with the inclusion of Abbott having performance figures equal to LFD x.
I am curious about the "8th test" omitted but passing Phase 3a.
With the published RNS - 23rd Nov SARS-CoV-2 | Rapid Antigen Test Update, this could allude to commencement of Phase 3a, "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."
"Performance of the test with clinical samples will now be evaluated as a precursor" could be representative of Phase 3a.
While, "precursor to a much larger clinical study" could be representative of Phase 3b = "Community research evaluation" per the PHE document.
With the published RNS - 21st Dec | License Agreement with Astrea Bioseparations, the disclosure of "we anticipate data from the first clinical trial soon" could suggest Phase 3b was underway at that stage. Alistair Smith was very bullish about the performance of the test during the recent Director's talk interview relating to news of Astrea Bioseparations partnership when commenting about COVID test progress. Alistair said he was "very happy indeed with the performance, we're now moving into the clinical testing" of the test. I am speculating now, I believe at the time of the Astrea Bioseparations note, Avacta had successfully completed Phase 3a evaluation, and the test was still in the middle of Phase 3b evaluation at the time the PHE document was released.
What I found very important and significant from the Astrea Bioseparations RNS , was the following "we have made significant commercial progress for ALL of our coronavirus testing solutions, establishing scalable routes to market for these products to meet the anticipated very high demand." Recall you can qualify for the tender by successfully completing only Phase 3a completion at the closing deadline.
Interested to hear your thoughts.
thanks,
Celtics.
A good find Muck.
It is encouraging and important to see Governments where financially possible necessary funding to build and advance testing solutions. 5 years seems sensible for a Virus that only came into existence not that long ago and has had such severe impact to Public Health and the basic functioning of an Economy that relies heavily on mobility and interaction.
I expect COVID-19 testing to be at a high level for sometime thru to end of 2022 at minimum, at least for basic infection monitoring post vaccine roll out. Note, early evidence on the K484 substitution in the Receptor binding domain in the "South Africa" variant suggests that there is an unfavorable impact on vaccine efficacy.
I am confident in that I expect the Avacta BAMS test to be a very powerful clinical diagnostic tool in that it is able to detect mutations (per Avacta RNS). Mass Spectrometry looks at the molecular weight of the captured targets and produces data on the molecular structure including mass to molecular charge ratios. Patrick Vallance mentioned a charge change with the "South Africa" variant during a recent Coronavirus briefing. Secondly the Avacta BAMS test is already somewhat de-risked in that it has been on sale as an RUO test for several months and Adeptrix has secured a significant partner in Bruker to commercialize the product within the clinical setting (subject to CE mark /FDA approval). Avacta will need to concentrate on the CONDOR /PHE evaluation in order to secure UK government orders.
Exciting times to be an Avacta shareholder. Remember Rome (or Tesla) was not built in one day. Many shareholders have been somewhat displeased with progress and Investor communication with the BAMS and LFT in the last 2-4 months, i think we should see some clarity very soon since the successful bidders towards the recent UK LFT tender will soon be announced.
thanks,
Celtics.
Thrilling post Unprecedented. I quite enjoyed reading this post from an employee at BBI solutions today.
https://www.linkedin.com/feed/update/urn:li:activity:6757585539425189888/
thanks,
Celtics.
In my opinion, an attempt to compare these proteins and how they influence test performance is like comparing Apples to Oranges. These are different proteins.
I agree with Monkshood that the Nucleocapsid Protein is significantly more abundant (circa 10 times). However, I am not sure a Nucleocapsid protein Antigen test for COVID-19 would detect Nucleocapsid protein within an intact virus particle unless a Virus lysis mechanism is included. Avacta have confirmed that it is able to detect the S1 Spike protein on both Intact and Detached virus particles [reference Avacta RNS - Avacta Ships SARS-COV-2 Affimer Reagents to Cytiva and Adeptrix].
LOD (limit of detection) is the smallest amount or concentration of an analyte in the test sample that can be reliably distinguished from zero, it does not take into account variables such as intact v non-intact virus particles.
RT PCR includes virus lysis in its test procedure in order to be able to split the Virus particle into its separately identifiable protein constituents; Spike, Membrane, Nucleocapsid, Envelope.
The Nucleocapsid protein contains the viral RNA fundamental to RT PCR tests.
As well as less cross reactivity to other seasonal coronaviruses by using a test for the S1 Spike protein vs Nucleocapsid protein (meaning higher specificity), a particular advantage of the S1 Spike protein tests is that it is effectively an infectiousness test. Past Coronavirus briefings conducted by the Prime Minister and Secretary of State have emphasized "we wish to identify infectious individuals to break the chains of transmission".
In my opinion, a comparison based on LOD or protein abundance on their own is insufficient in comparing test performance.
Multiple KPIs that includes; Sensitivity, Specificity, LOD taken together help form an assessment on test performance.
Separately, Avacta does have the capability to produce a Nucleocapsid protein test should they choose to do so or potentially multiplex. [reference Avacta RNS - Update on COVID-19 Antigen Diagnostic Test Development with Adeptrix].
Following link provides some useful information - https://www.enzolifesciences.com/science-center/technotes/2020/july/how-do-coronavirus-disease-covid-19-tests-work?/
thanks,
Celtics.
It will be 20 days tomorrow since the 10th November Company tweet that “We are conducting a clinical evaluation of the BAMS assay at several sites in the UK and will update the market shortly when we have those data.” This is the initial clinical validation and I would expect we see results from that this week. The company has set expectations that full clinical validation will be during 4Q providing we have a successful initial evaluation per the Interims presentation ... We are still on track and the company has not suggested otherwise. Thanks, Celtics.
Greg Hill, President and COO at Hess, supporting John Hess on the call explicitly answered "still underway ... results by the end of the year". A higher chance of a positive outcome the longer that drilling continues.
Some discussion on Tanager-1 on investor call from 36.30 mins. Drilling still underway ... results expected by year end. If there was no oil ... I would think we would have known by now ... Thanks, Celtics.
Covid-19 herd immunity theory dealt blow by UK research
https://www.ft.com/content/f75418a9-9ef5-4684-9222-758635e906b1
thanks,
Celtics.
Vaccine Development and Deployment Hurdles –
1) Efficacy and Safety profile - Consumer Confidence is low. Concerns on Safety profile and “record” speeds of development including perceived Political pressure on regulatory bodies such as the FDA has elicited a negative effect.
2) Manufacture of billions of Doses – Some Vaccines require two doses per patient.
3) Medical Equipment shortages – Medical Grade Glass Vials, Hypodermic Needles and Syringes.
4) Cold Storage - Vaccine "cold chain" – Upgrade of cold storage infrastructure including vehicle and aircraft adaptation to avoid Vaccine spoilage. mRNA Vaccines require ultracold temperatures - Moderna Vaccine requires -4 degrees Fahrenheit (-20 degrees Celsius). Pfizer Vaccine requires -94 degrees Fahrenheit (-70 degrees Celsius). Cold storage infrastructure and supply chain upgrade is difficult for even the most developed countries. Introducing such an advanced Supply chain in developing countries along the Atlantic margin will prove difficult. Nick Jackson, head of programmes and innovative technologies at the Coalition for Epidemic Preparedness Innovations (Cepi) - “I can't emphasise enough the complexity of maintaining an absolute temperature from the depo to the distribution centre to the airplane to the delivery truck to the surgery and the refrigerator in the doctors”
I believe the demand for Rapid Antigen testing will remain unaffected by the deployment of a Vaccine throughout 2021 to early /mid 2022 … assuming a Vaccine(s) is approved in 4Q2020. Testing Demand likely will continue to outstrip Supply. Robert Ford, Abbot CEO commented on an Investor Conference call - “It’s clear that the need for testing is large and it isn’t going away, … Even when you have a vaccine ... I can see patients going to physician’s office with a fever, and they want to know is it influenza? Is it the flu? Is it COVID?”.
If we extend the Physician’s office to the other broader areas of Society and Economy. Infection Control is expected to be high throughout 2021 in order to return Economies to pre-Pandemic levels. The below is not an exhaustive list –
1) Travel & Leisure – Cruise Ship
2) Education - School & College Campuses
3) Travel - pre-Flight
4) Workplace - Food Packing, Corporate Offices
5) Housing - Care /Nursing & Retirement Home,
6) Healthcare - GP practice, Hospitals
7) Sports Venues - Football, Rugby, Basketball
8) Entertainment – Cinemas and Theatres
A WHO official, while interviewed on BBC Radio 4 commented that we need “billions” of these Rapid Antigen tests, while knowing progress on Vaccines was being made. While some countries may have the ability to Upgrade their Infrastructure and Supply Chain and successfully execute a country vaccination programme in 2021, a long list of countries do not and will not have that capability without substantial investment.
A global Vaccination programme will take some years in my opinion.
Thanks,
Celtics.
Staying Objective as an Investor – Avacta Investment Case with a Successful Vaccine (part 1)
Statements made by credible scientists and medical experts involved in some significant capacity with respect to Pandemic control –
1) Prof Sir Jeremy Farrar - "Things will not be done by Christmas. This infection is not going away, it's now a human endemic infection." "Even, actually, if we have a vaccine or very good treatments, humanity will still be living with this virus for very many, many years.... decades to come."
2) Prof Sir John Bell - "The reality is that this pathogen is here forever, it isn’t going anywhere. Look at how much trouble they’ve had in eliminating, for example, polio, that eradication programme has been going on for 15 years and they’re still not there." "This is going to come and go, and we’re going to get winters where we get a lot of this virus back in action. The vaccine is unlikely to have a durable effect that’ll last for a very long time so we’re going to have to have a continual cycle of vaccinations, and then more disease, and more vaccinations and more disease" …. "There's going to be lots of this virus around for a long time, probably forever. It’ll likely mutate"
3) Dr Anthony Fauci - "I don't see this disappearing the way SARS 1 did … It is so efficient in its ability to transmit from human to human that I think we ultimately will get control of it. I don’t really see us eradicating it"
4) Dr Mike Ryan - "This virus may become just another endemic virus in our community and this virus may never go away"
5) Sir Mark Walport - "This is a virus that is going to be with us forever in some form or another, and almost certainly will require repeated vaccinations."
6) Sir Patrick Valance - "I think it’s unlikely that we will end up with a truly sterilising vaccine – i.e. something that completely stops infection – and it’s likely that the disease will circulate and be endemic"
Thanks, Celtics.
Some believe that a vaccine may reduce demand for COVID-19 testing, including the rapid antigen test that Avacta are near to commercializing.
I believe that the combination and integration of a vaccine with a disciplined testing strategy is what governments are looking at as a long term solution. Development, storage and distribution of a vaccine is challenging and a roll out will likely take form in waves starting with high risk persons.
Some statements made by credible commentators on COVID-19, and while I do appreciate some of those were made some time ago, there is a very clear message underpinning.
Prof Sir Jeremy Farrar - "Things will not be done by Christmas. This infection is not going away, it's now a human endemic infection." "Even, actually, if we have a vaccine or very good treatments, humanity will still be living with this virus for very many, many years.... decades to come."
Prof Sir John Bell - "The reality is that this pathogen is here forever, it isn’t going anywhere. Look at how much trouble they’ve had in eliminating, for example, polio, that eradication programme has been going on for 15 years and they’re still not there." "This is going to come and go, and we’re going to get winters where we get a lot of this virus back in action. The vaccine is unlikely to have a durable effect that’ll last for a very long time so we’re going to have to have a continual cycle of vaccinations, and then more disease, and more vaccinations and more disease"
Dr Anthony Fauci - "I don't see this disappearing the way SARS 1 did … It is so efficient in its ability to transmit from human to human that I think we ultimately will get control of it. I don’t really see us eradicating it"
Dr Mike Ryan - "This virus may become just another endemic virus in our community and this virus may never go away"
Sir Mark Walport - "This is a virus that is going to be with us forever in some form or another, and almost certainly will require repeated vaccinations."
Thanks,
Celtics.
PL75, I can appreciate the frustration, however I don't think there is too much longer to wait for BAMS clinical evaluation since it began no later than the 28th September. I reference the last slide in the investor meet presentation - "BAMS clinical evaluation now beginning after long delays in the sample access process".
thanks,
Celtics.
Omega Diagnostics CEO has confirmed today on an Investor presentation that talks have taken place between Avacta and Omega. He continues to say that Omega want to address the UK challenges and if that means bringing onboard Avacta then they will do that.
thanks,
Celtics
I recognize that people may have been concerned by the fall in price over the past few days along with the broader markets.
We should recognize that nothing has changed over those days with the fundamentals of the company nor the situation with the Pandemic (in fact the rate of infection transmission has clearly been getting worse broadly across Europe).
We will have a need for testing (mass or case specific) for the upcoming months and likely several years (the long term effects of this virus are unknown and mitigating transmission is the highest priority along with the roll out of a successful vaccine). While vaccines are being manufactured the distribution to the global population will take time - months and years.
Large parts of the economy are in more distress than others due to the Pandemic and the effect that this virus has had on consumer behavior. Consumption will return upon the successful integration of testing with vaccine deployment.
The investment case for me has only increased over the last couple of days.
I think it's important to be patient … new tests validation takes time (someone referenced an FDA transcript and thank you for sharing that information, no Antigen tests have so far been submitted for an EUA in the home use setting so far at the time of that discussion which was quite recently). Only those tests that meet the defined standards are going to be deployed for use in the various settings and the process for clinical validation may be more extended for a test that is intended to set up for Mass screening use.
I think the demand for tests will exceed supply in the next 12 months.
*additional note - Many Universities have Mass Spectrometry laboratories.
thanks,
Celtics.