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https://www.**********.co.uk/articles/traders-cafe-with-zak-mir-weekend-bulletin-board-heroes-may-29-91bc43e

For those interested in TA and charts, there is a pretty positive assessment of Avacta (May 29th) by Zak Mir on Vox Markets. For those not interested, just ignore and don't respond.

The interesting point in the Reuters article is: “Novartis (NOVN.S), which made around a third of its revenue from oncology in 2021, does not have any ADC treatments in the works.” I am sure that Novartis does not want to lose out to all the new ADC drugs being produced so must be looking to make an acquisition to fill the gap? I wonder which companies will be on their wish list? Exciting times.

If they don’t start treating the third cohort soon, the promised update of the phase 1a data is going to be much delayed. Are Avacta obliged to inform the market of dose escalation or could it have happened already?

jaffjoon - I agree. There is an excellent future for inhaler treatments for not only Covid but also other chronic and acute inflammatory conditions of the lung such as COPD and Asthma. The market is potentially enormous but we will need patience as this now has to be a long term hold!

Following the news that the dose of AVA6000 is going oto be increased, does anyone know if the exisiting patients in the trial who had the original dose regime can continue in the trial and receive the increased dose subject to clinical condition? If so, that would speed up the trial considerably.

Also, does anyone know if Avacta will have had to submit a second clinical trial proptocol for the US research or is it being carried out under the existing protocol?

It seems to me that Avacta will either be taken over by BigPharma or will negotiate a deal/licence with a Company to speed up the development of the pipeline of drugs and get them to market as early as possible whilst maintaining the IP and patent. They are just too small to try to do everything themselves.

If there is a takeover bid, does anyone know what the AIM rules are in relation to this? Does the buyer have to build up a stake in the company first? Obviously, any deal would have to be approved by shareholders.

Previously posted

"AVA6000 - A Potential Drug Revolution
The more that I think about the potential for the pre CISION platform and AVA6000 to improve the treatment of many cancers, the more convinced I become that Avacta is set to revolutionise chemotherapy as we know it. Results from the animal studies indicate that AVA6000 can achieve 18x the concentration of Doxyrubicin in the tumour compared to heart tissue (18:1). The equivalent ratio for Doxyrubicin alone is 1:1 resulting in problems of cardiotoxicity and restrictions on the total dose that can be administered. If the animal results are anywhere near replicated in humans, it will result in a complete revolution in chemotherapy and cancer survival rates. The potential impact cannot be overstated!

Even if AVA6000 only produces a 2:1 tumour/heart ratio in humans, this would be a major therapeutic breakthrough. The market for plain Doxyrubicin would virtually disappear overnight as it would be unethical to treat patients with an inferior and more toxic formulation of the drug. And then there are all the other Pro drugs in the pipeline....

Of course, the usual caveats relating to Biotech companies applies but I think all the indications are that we will hear some absolutely ground-breaking preliminary data soon."

We just have!

The more that I think about the potential for the pre CISION platform and AVA6000 to improve the treatment of many cancers, the more convinced I become that Avacta is set to revolutionise chemotherapy as we know it. Results from the animal studies indicate that AVA6000 can achieve 18x the concentration of Doxyrubicin in the tumour compared to heart tissue (18:1). The equivalent ratio for Doxyrubicin alone is 1:1 resulting in problems of cardiotoxicity and restrictions on the total dose that can be administered. If the animal results are anywhere near replicated in humans, it will result in a complete revolution in chemotherapy and cancer survival rates. The potential impact cannot be overstated!

Even if AVA6000 only produces a 2:1 tumour/heart ratio in humans, this would be a major therapeutic breakthrough. The market for plain Doxyrubicin would virtually disappear overnight as it would be unethical to treat patients with an inferior and more toxic formulation of the drug. And then there are all the other Pro drugs in the pipeline....

Of course, the usual caveats relating to Biotech companies applies but I think all the indications are that we will hear some absolutely ground-breaking preliminary data soon.

Just managed to order some LFTs from the government website and received a pack of Innova LFTs! Didn't know they were still using them as recently have received Flowflex LFTs. Does anyone know whether the Innova test can even detect Omicron??

I recently received the Bioserve Sales Catalogue for 2022. The Avacta AffiDX LFT is listed and is priced at £182.00 for 25 tests. The other LFT tests listed are all more expensive except a Pen test produced in Canada (£146 for 20) and the Healgen Orient Gene Test (£75.00 for 10) which are about the same in price but, as we know, far inferior in performance. I agree with others that any non-availability of the Avacta test will be because Avacta are withholding supplies until it receives authorisation to sell in the UK.
A Happy and Prosperous New Year to Everyone!

The Health Security Committee (HSC) of the EU publishes a "Common List of Covid-19 Rapid Antigen Tests". This is a common list of Rapid Antigen Tests (RATs) that are considered appropriate for use in the EU and provides a common framework for the use of RATs and the mutual recognition of RATs across the EU. The list does not include RATs for self-testing. The latest list was published on 21st October and is the 7th update this year. The list can be found at:
https://ec.europa.eu/health/security/crisis-management/twg_covid-19_diagnostic_tests_en
Recommendations for updates to the list are made by the Technical Working Group on Covid-19 Diagnostic Tests. The aim of this group is to review and evaluate proposals by EU countries and manufacturers for tests to be included on the Common List.
In order for devices to be included on the Common List, manufacturers have to ensure that their device is included in the "Covid-19 in vitro Diagnostic Medical Devices Database" which is hosted by the EU JRC. The database can be found here:
https://covid-19-diagnostics.jrc.ec.europa.eu/devices#form_content
The Avacta LFT is on this database.
Once the device is listed on this database, manufacturers can submit a request for the device to be included on the HSC Common List of RATs. The request will be reviewed and evaluated by the Technical Working Group.
Although a test only needs a CE marking to be sold for professional use in the EU, there is clearly an advantage to be included on the Common List. It must be presumed that Avacta has made a request for their test to be included in the Common List.

I have searched without success to find the process for the authorisation of self-test use of RATs in the EU (also referred to on this board as HUA). Hopefully Medusa have identified the process. If anyone has the appropriate links, I would be very interested.

Agent B. Thank you for posting the link to the EU list of approved Covid Antigen Tests. Many of the tests have been evaluated by the Paul Ehrlich Institute (PEI) in Germany. They publish a list of evaluated tests which includes 10 from GB including Surescreen and Mologic Tests. The sensitivities range from 90.6%-96.9% and the Specificity from 98.8% - 100%. The test with 100% specificity had only 90.6% sensitivity. I don't know why Avacta is not listed on the EU list yet but it seems to be a better performing test than the other GB tests evaluated by the PEI and those on the EU List. Lets hope Avacta/Medusa get their approval soon!

RevoltingPeasant. It is difficult to find online but the regulations can be found at: https://www.legislation.gov.uk/uksi/2021/910/made. Para 34c states the transitional arragements and the dates. More details on the approval process can be found at COVID-19 test approval: how to apply: https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply. The regulations state that the SoS must set up a register on gov.uk listing all the approved tests but I can't find it. Happy reading!

Avacta AffiDX SARS-CoV-2 Antigen Lateral Flow Test still for sale on Bioserve website. Unless it has received authorisation under the Medical Devices Regulations, it will be illegal to sell it in the UK from 1st November. I suspect we will be the last to know!

I may have missed previous discussion on this but the above regulations require all COVID tests being marketed in the uk to have been approved by 31st October. If no approval, no sales allowed from 1st November.
Does anyone know:
1) has Avacta submitted their LFT for approval?
2) has it already been approved?

I don’t recall this being mentioned in the recent webinar so feel completely in the dark - like everyone else!

Part 2:
"It is important to note that the approval for the exceptional-use authorisations is time-limited and is granted on the condition that a CE mark for self-testing, the more normal standard regulatory approval process, will be obtained by Innova and Orient Gene.
Collaboration between industry and Government continues to be a priority and we are hugely grateful to all the manufacturers and suppliers that have come forward to offer their assistance in producing LFD tests. The UK was ahead of the world in embracing LFDs, and they continue to be a central part of the Government’s strategy to combat COVID-19. These innovative technologies will allow infectious individuals to be identified, isolate and prevent onward transmission, reducing illness and the burden on the NHS and saving lives."

I wrote to my MP in July re the proposed legislation regarding LFTs and their authorisation. I have just received this reply for what it is worth sent in two Parts :
Part 1
"Alongside the symptomatic testing service, NHS Test and Trace is using rapid-testing technologies for asymptomatic individuals and to improve our detection of positive cases. Roughly one in three people who have the virus do not have symptoms and could therefore be spreading the disease without knowing it.
The process of deploying a lateral flow device (LFD) test, such as those supplied by Innova and Orient Gene, into the mass-testing programme is robust, consisting of detailed validation and evaluation of the LFD prior to deployment. LFD tests have been rigorously tested and are safe for regular use; any suggestion otherwise is inaccurate and potentially harmful.
All LFD tests that we procure undergo an extensive clinical evaluation by Oxford University and Public Health England (PHE) Porton Down. This is to confirm that the LFD tests display performance characteristics desirable for mass-population and community-based testing. The desirable performance characteristics are high specificity and sensitivity against the viral loads associated with infectiousness, and the work performed at PHE Porton Down assesses the clinical performance of LFD tests.
We applied to the Medicines and Healthcare products Regulatory Agency (MHRA) for an ‘exceptional-use authorisation’ for the Innova LFD, and Orient Gene independently applied. The MHRA provided the exceptional-use authorisations to fill short-term gaps in the market, as no CE-marked self-tests were available. Both devices have subsequently been deployed in the UK, with the exceptional-use authorisations providing the regulatory authority for deployment.
The process of applying for an exceptional-use authorisation requires the applicant to provide data to support the intended use of the LFD test. In these instances, we, on behalf of Innova, and Orient Gene provided the MHRA with data in support of applications for LFD tests that use a lower nasal swab and are intended for use on asymptomatic
individuals. Furthermore, we conducted field-service evaluations before deciding to deploy the LFD tests. The results of the field-service evaluations can be found at www.gov.uk/government/publications/lateral-flow-device-performance-data."

Browsing the Diagnostics pages of the Avacta website, I was interested to see that Avacta employ a Director and a Senior Manager of Business Development for North America - one based on the West coast and one on the East. Can anyone enlighten me as to whether Avacta generates any income from North America?