Member Info for jdt1990

There's enough warrants even at 2p and below to "keep the lights on" until financing sorted and avoid a raise if they could get their act together and move the SP up there. It's just the usual clusterf*ck from LC which has spiraled this into the pit its in.
The Mkt cap Vs project potential says a lot really about the confidence the market has in him. If they could avoid a raise pre Blyvoor financing, then as you say, get those 3p warrants exercised once that's sorted and it funds Haneti drilling too.
My concern with a raise, is that KAT love to add layers and layers or warrants which just stick the knife in for PI's when already diluted.
FFS they just need something to move it!

"Following the exercise of the foregoing warrants, the Company currently has 117,274,999 warrants outstanding, including 10 million held by Power Metal Resources plc (LON: POW) exercisable at 1.25p per warrant, 5.1 million held by participants in the October 2019 fundraise exercisable at 1.50p per warrant, 17.2 million warrants held by participants in the March 2020 fundraise exercisable at 2p per warrant, 36,666,666 warrants held by participants in the June 2020 fundraise exercisable at 3p per warrant, and 48 million held by participants in the December 2020 fundraise exercisable at 3p per warrant."

Good old Civil Service eh, never any rush! Not like AffiDx will have any use in the pandemic.....
The doc contradics itself and has both 5 and 6 days in there (P37)
"Within 6 working days from submission you should receive an email confirming the outcome
of the application. Some devices may be registered, some may be rejected."
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978379/Device_Registration_Reference_Guide_April_2021_Final_v1.pdf

P37 of the attached - you’d think given the situation and type of device they’d have got their skates on with approval - guess that’s the public sector for you!
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/978379/Device_Registration_Reference_Guide_April_2021_Final_v1.pdf

The MHRA say a response within 5 days in their conformity assessment docs so I think it is most likely intra day tomorrow given it was submitted Monday.
As you say if it came post 4:30 Friday could be 7am RNS but I would say most likely intra day tomorrow.

at 9m mkt cap hard not to top up here as a buy and hold - potential upside is huge

Get a grip Tony you clown - the final piece is with the MHRA Mologic/AVacta have now done their piece. The MHRA site says 5 days turnaround so could be today/Monday but what we do know, is that it's now out of AVCT's hands.
Sick to death of whiners on here.

Haha PL I think Sir Al went all Donald Trump there with the staged signing of 2 blank A4 sheets. Love it!
Just needs to have a video of him showing it to the crowd

Don’t make me wish another weekend away Al - bring home the bacon with a Friday special!

300% increase and 25,000 oz planned for this year, brilliant news! Not just exciting about this producing gold at a cost of less that $600/oz but what that revenue could unlock with other projects!
My one question....does this paragraph basically say they aren’t sure about how best to extract the gold from the carbon and might need short term funding to be able to extract, or is it an optimisation of extraction issue? Just no actual mention of a gold pour expected date.
“The Company is continuing to review the options available for extracting saleable gold from the loaded carbon it is producing, including toll treatment or expanding its own processing facility to include an elution plant and gold room. In this regard, Goldstone expects to make a decision shortly depending on the terms offered by existing third party processing facilities and any financing options that may be available, however notes that additional funding may be required in the coming months depending on the timing and cost associated with such arrangements.”

Yeah that was a bit of sarcasm there Vegas.
Although now I think about it, wonder if some of the LFT retained profits could go towards an AVCT gift shop? Sir Al calendars - 12 different shumper combos and Paul Hill from Vox flogging them at the door.
In the small print on each calendar "NOTE these calendars use Sir Al time, not to be used for everyday purposes"

Reckon we can rope in Andy Murray to play NDN71/Roly/MFM and a few others for the film adaptation? He's about the right level of boring to manage those lot

This thread has brightened up the day - Scaredy some epic dedication to the cause!
Shame Sir Al wasn't there doing some meet and greets could have asked for a calendar so you don't forget what day it is again and maybe got him to sign your shumper!

Q19: Is the performance of the test the same for all variants or does that drop-off?

The performance of the test is very similar for all the variants tested. No significant drop-off has been detected and all clinical studies have been done on “all comers” with no pre-selection of particular variants.
Q20: Please would you make the slides available asap so we can make notes

you can access on the IMC platform post meeting
Q21: Would you agree that the anterior nasal sampling needs to be communicated more to educate the critics of LFT?

Anterior nasal sampling is much more patient friendly than nasopharyngeal sampling. This is a major advantage for the end user of the AffiDx test. LFT critics are concerned about how well the end user might sample the patient or themselves using nasopharyngeal swabbing which is very painful and unpleasant. We will continue to educate the market as to the advantages of the AffiDx test.
Q22: Is the Company looking at building / acquiring proprietary manufacturing capacity for its rapid antigen test?

The Company has a strategy of partnering with contract manufacturers for the test to build capacity.

Q14: When do you intend to take TMAC into a phase 1 clinical trial ?

The precise timing of that will depend on the pre-clinical and translational development progress this year. We are aiming to be in a position early in 2022 to select a candidate TMAC molecule for clinical development which involves generating the data for a regulatory submission, developing the CMC (manufacturing) processes and submitting to the FDA or MHRA for clearance for the clinical study. Following candidate selection, it may be around 18 months before we are in a position to dose first patient.
Q15: Are you still using the same Affimers that were generated about a year ago and sent to Cytiva or have they been tweaked?

A large number of Affimer reagents that bind the spike antigen were generated in 2020 and worked on with Cytiva and other partners throughout the process of developing the AffiDX SARS-CoV-2 antigen rapid test. The Affimer reagents themselves were not “tweaked” or modified following their initial discovery in 2020.
Q16: Will you be providing the UKGov or any other government with the Affimers reagent for the creation of their own LFT?

The Company has no plans to license the Affimer reagents to the UK government at the present time.
Q17: Would pre | CISION also target secondary tumours that have not necessarily been identified in a patient with an identified tumour? (thereby treating secondaries that may if not treated develop further down the line)

pre|CISION will target tissues where FAP is upregulated which includes secondary tumours. It is not a pre-requisite for pre|CISION to work that there is an already identified tumour.
Q18: Could you talk about your decision to focus on S1 vs S2 and the implications of that with potential mutations of the virus?

The benefit of targeting spike protein (S) versus nucleocapsid protein (N) is that S is a stable, soluble protein that we expected could be efficiently collected in clinical samples without degradation and would be released from the swab and not stick to the sample tube walls during processing for the test. The N protein is hydrophobic and less stable and we hypothesised that more would be lost during the sampling process.

The disadvantage of using S protein is that it is more susceptible to mutations as the virus spreads than the N protein. In simple terms, the parts of the S protein that mutate are generally quite restricted and the AffiDx lateral flow test is not affected by the known variants that we have tested to date because the reagents do not bind to the S protein in those regions that mutate.

Since the Company has been able to develop very sensitive lateral flow tests and ELISAs which do not appear to be susceptible to the mutations in the variants, we are satisfied with our selection of the S antigen as the target.
Q19: Is the performance of the test the same for all variants or does that drop-off?

The performance of the test is very similar for all the variants te

Q10: Is Avacta planning to market the AffDxTM SARS-Cov-2 rapid antigen test in the United States in the future? Thanks. Nick

The United States represents a significant market opportunity and we are looking at how to achieve regulatory approval, as well as whether a professional use or consumer self-test is the most appropriate product for the US market. We will update shareholders when there is material progress in this regard. Our primary focus right now is selling the test in markets that accept the CE mark for which the market opportunity is substantial.
Q11: With the extraordinary selectivity of the Affimers - would it be possible to provide an ELISA panel capable of rapidly identifying known variants - and by exclusion therefore new variants to be sequenced ?

Affimer reagents have been generated in the past that can differentiate between proteins (antigens) with as few as two mutations in the primary sequence. If we understand the question correctly, then the answer is yes, it is possible to develop Affimer reagents that are specific to each new variant of a virus. The clinical need for that in an ELISA is not clear since it requires centralised facilities and therefore PCR is just as good a tool for epidemiological monitor of new variants.
Q12: Chinese researchers at Jinan University have been working with FAP activated Doxyrubicin for >10 years. See published research at https://pubmed.ncbi.nlm.nih.gov/21284542/. How does this relate to Avacta's FAP activated program? How secure are Avacta's patents in the FAP activated pro-drug arena?

The Jinan group failed to achieve selectivity to FAP. In mice where FAP is not present (so called “FAP knock-out mice”) their drug is still activated by something. In contrast, the preCISION substrate for FAP is not activated in FAP knock-out mice. The Tufts/Avacta IP claims the mechanism for achieving this specificity to FAP and has been granted by patent examiners in multiple different countries acknowledging that the FAP selectivity is novel and patentably distinct.
Q13: What is the status of the neutralising Affimers that were highlighted in May 2020? "Avacta has now demonstrated that several Affimer reagents also perform this blocking function and the Company is now seeking a partner that has the resources available to develop a neutralising Affimer therapy as quickly as possible."

We announced in July 2020 that we had licensed the neutralising Affimer reagents to Daewoong Pharmaceutical for potential development in cell therapies for the treatment of COVID-19 and other infectious diseases. Due to commercial confidentiality we cannot provide information about Daewoong’s development programmes but our priority with Daewoong, through our joint venture AffyXell, is development of stem cell therapies for transplant rejection and not for COVID-19 treatments at this time.

Q1: Is the company looking to list in the future on the NASDAQ or are their any other goals in the pipeline to expand the company.

The Company continually reviews the strategic and capital markets options to maximise shareholder value and will communicate such opportunities with shareholders to seek their approval at the appropriate time.
Q2: Will the huge quantities of lateral flow testers be recycjed? If yes how will they be gathered and processed? And by whom? Thankyou Eddy

Q3: Why did the saliva test fail, what were the technical reasons for the failure to detect or manufacture when there are about 4 other working saliva tests internationally?

Q4: Does the lateral flow test detect the South African Covid variant?

Q5: Has BAMS been shelved at this point? could you please give an update to investors and explain where you are at with the clinical evaluation in the UK hospital reported to be "in progress" in the RNS on February 24th?

Q6: When are you expecting CE to be completed for the test? How soon will a Home Use CE Mark come after a successfully Professional Use CE Mark?

Q7: Are Abingdon, BBI and Mologic still partners for producing the LFT? Nothing has been said with regards to Abingdon and BBI for a long time.

Q8: Which hospitals will the cancer trials be held at?

Q9: It was briefly mentioned that the LFT framework is now "plug and play" with new Affimers for variants/viruses. Practically, how will this process work and how often do you envisage that having to happen?

A significant proportion of the development time was invested in getting the lateral flow test to work with anterior nasal samples and this would not need to be re-developed if the a new Affimer reagent was used to detect a new variant or completely different virus. Practically, the lateral flow test performance would be evaluated with the new Affimer reagent to ensure that analytical performance in the laboratory was not affected. We anticipate that this would take a few weeks following the generation of the new Affimer reagent. The new test would then need to be evaluated in the clinic to confirm the clinical sensitivity and specificity which again would take a few weeks. Since this would be a new test from a legal perspective a new self-declaration of conformity would need to be made to affix the CE mark to the product. Our experience of new variants thus far suggests that we will not need to do this very often if at all.

Exactly tigg they're playing this like its a fledgling miner with a potential resource but little drilling , questions over funding / how to extract, no partner etc.....madness.
This is derisked month by month and NCM are not hanging around.
THEY ARE LITERALLY STARTUING TO ENTER THE OREBODY!
Paddys tweet yesterday hit home how much drilling is still to be included in the resource estimate. As Sandeep has said "every drill hits mineralisation at HAV".
Some point soon this becomes as derisked as it can get and a simple (crudely done of course) resource size * commod price - AISC * 30% which the market cannot play around with and have to take note.
That resource size wont be 4.2m Oz equivalent for long!

Cheers for that Celtics - very useful!

This is the wording from the EU directive (So for the purposes of Europe, the conformity assessment is done by the manufacturer i.e. Mologic, so the fact MHRA have had to get involved is interesting)
"Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group in vitro diagnostic medical devices into two main product classes; whereas, since the large majoritybof such devices do not constitute a direct risk to patients and are used by competently trained professionals, and the results obtained can often be confirmed by other means, the conformity assessment procedures can be carried out, as a general rule, under the sole responsibility of the manufacturer; whereas, taking account of existing national regulations and of notifications received following the procedure laid down in Directive 98/34/EC, the intervention of notified bodies is needed only for defined devices, the correct performance of which is essential to medical practice and the failure of which can cause a serious risk to health;"
P3 Section 22 of the below:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31998L0079&from=EN

https://www.gov.uk/guidance/ce-marking

Notice the last sentence - MHRA cant do the approval for Europe, which suggests UK sales are imminent. I assume that is to make it easy for Medusa to sell to UK and Europe from day 1.

3. Identify whether an independent conformity assessment is required from a Notified Body
Each directive covering your product specifies whether an authorised third party (Notified Body) must be involved in the conformity assessment procedure necessary for CE marking. This is not obligatory for all products, so it is important to check whether the involvement of a Notified Body is required. These bodies are authorised by national authorities and officially ‘notified’ to the European Commission and listed on the NANDO (New Approach Notified and Designated Organisations) database.

UK conformity assessment bodies can no longer carry out mandatory conformity assessment for products being placed on the EU market.