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Not really sure how relevant for AVCT but might give some idea how long it takes ?
Adeptrix "Custom BAMS Assay Development Timeline "
https://adeptrix.com/custom-project
@BBN - I haven't tried to provide a timescale for BAMS as I think there are a few unknowns in there. I do think 3 - 4 weeks is enough time to have conducted a clinical validation. For me the unknown in there is how long each manufacturer might take to tailor the basic assay to their kit. Whilst COVID-19 is obviously a big deal, for Mass Spec manufacturers it won't be that big an earner alongside everything else they provide on an ongoing basis and so preparing the kits and marketing them may not float their boat as much as it does ours. I've worked with Agilent, Waters, Brukker and ThermoFisher to name but a few in either their current or legacy forms. I placed the biggest Agilent UK HPLC contract they had ever had at one point and I tell you they were not that nimble or keen to get of their backsides and provide a service so I'm not convinced this will be priority for any of them Hence I haven't tried to set a timeline. All that said you are right in your assumptions as far as I can determine so anytime in the next couple of weeks wouldn't surprise me.
Ophidian
Note also that the evaluation is being conducted state side also, which of course supports FDA approval and US use.
Thank you Ophidian, sorry I lost your last response, hence the late reply.
Taking your list one step further and applying it to the BAMS test, would indicate that the initial live patient samples evaluation should be almost complete.
From 9th June RNS ;
"evaluate and optimise the BAMS assay using patient samples at laboratory sites in the UK and US which will be done imminently before moving to manufacturing, clinical validation to quantify the sensitivity and specificity and CE/FDA approval for professional use in the summer."
Looking at what GDR achieved with Cytiva post their collaboration, I would think 4-5 weeks would be enough to complete the process and get the product on sale.
So early August first sales?
I think the issue is mixed messages which is poor. In the video released the DST before the optimisation RNS we’re told we’re on track for end of June re manufacturer transfer/design freeze and presumably they read Turner Pope’s research note Before it’s published.
From their note following the RNS -
TPI considers this is likely to be satisfactorily completed within three or so weeks and meanwhile Avacta is working and consulting with different manufacturers with a view to compressing the normal manufacturing, clinical validation and regulatory timelines in order to bring a CE-marked product to market as quickly as possible.
@BBN
"we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers."
could be as easy as deciding to tell them to use Avacta set-up number six or whatever denominator they use.
Ophidian
@BBN - again I think you need to separate "The Strip" that AS continually talks about from "The LFD".
Ophidian
Having said all of that, in the latest Directors interview, Dr Smith said ;
"Once we’ve optimised the test strip then we’ll have a design that we can transfer to manufacturers who we’re putting in place at the moment."
Hence my design freeze comment. That process was highlighted as being the end of June, just 1 day before the 24th June update on the initial positive results from the prototypes, where Dr Smith said ;
"we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers."
Take from that what you will.
@Ophidian Firstly thank you for your kind thoughts, all good here where I live thank you.
Understood. My impression has always been that no design would be passed to manufacturers until it was fully complete. Effectively the design freeze. After all we are talking multiple manufacturers here.
That being prototypes that are sufficiently complete to allow said manufacturers to "first of all" produce validation batches for clinical studies. I assume that these manufacturers have produced something similar before (eg. Abingdon) and in reality it is the strip that is the differentiating tech here.
As I just alluded to, 23rd June AVACTA video presentation ;
"we are now in discussion with a number of manufacturing partners, who will take the prototype design from Cytiva when its ready and firstly produced validation batches for clinical studies with patient samples."
I appreciate that there are other layers and no doubt several overlapping functions, which aren't worth a CEO explaining, but if anything that adds weight to the argument that the end of June tech transfer commencement is a significant milestone.
That all said, we don't need to labour the point too much. Thank you Sirius B for your response also. Whatever the case, I tend to agree that by end of August, the clinical studies and CE mark can be concluded. As I highlighted yesterday evening on Twitter, the key upfront market is the one involving healthcare professional use, which should be an easier path to market. If AVCT achieved nothing else but that with this test, it would in my view be a significant success.
I see no reason why that shouldn't be achieved by late August, tech transfer dates defined or not.
@BBN - I maybe should have said, I think the Clinical Validation batches can be easily and very quickly produced and do not have to wait for completion of the manufacturing Validation. Even for the biggest clinical trials on pretty much all products, even phase III samples are made at pilot scale and sometimes not even on production kit. For a simple medical Device Clinical Validation pilot scale batches off demonstrably representative kit would be fine.
Ophidian
BBN, my view is that we will be on plan to the one shown in the presentation, i.e. end of June, as whilst the test is optimised there is nothing to stop the manufacturing partners being put in place and starting the process of manufacturing the validation batches concurrently. They can complete initial planning and tech transfer activities whilst the test is being optimised. Great if it’s finished this week but if it takes a couple of weeks I think they are likely minor tweaks that can be incorporated into the final batch towards the end of the timescale. The actual production will only be for a couple of hundred tests so total time to complete should not be any longer than the timeline suggested. I expect we might see a manufacturing update or partner RNS this week.
Hi BBN - hope you the twins and the family generally are safe and well. Nice to be in discussion with you again. I think we need to be able to differentiate the "strip" from the totality of the LFD device to be able to pick apart the detail in this. The strip is after all the real nuts of the test device.
You quoted: "work continues now to refine the test strip design, optimise its performance and get the best detection limit possible."
My interpretation of this is that from data from the lab tests they are now balancing the many variables in play for optimal performance of the strip. There is a trade-off between things like speed of result vs. residency time on the strip. Concentration of the affimer and rheology / chromatography. These things probably include different blends of the different affimers, slightly different membranes potentially (maybe as simple as thickness or width to affect migration rates and residency times). My guess is that during the lab tests they didn’t just have ONE test strip they probably had a few. Typical development defines a number of what are called CQA’s (critical Quality Attributes) the early lab testing typically tested the ranges of these defined CQAs hence I think there will have been different Strips on test. Once the data are gathered the “Design Space” can be mapped and the optimal point within that Design space to achieved the best compromises against the various CQA’s can be found. As I said a couple of days ago in a post to another contributor in all probability that design decision is just a VC between Avacta and Cytiva to agree the interpretation of the data and the relative perceptions of Risk associated with the choices made.
Once the optimised “Test Strip” is agreed THEN Cytiva can get on with their finalisation of design criteria or as you said “optimisation of the lateral flow test” so that they can THEN pass a finalised design on to other manufacturing partners
"Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta."
I really doubt that they will have chosen to modify the critical dimensions of the test device unless absolutely crucial to performance as they wouldn’t want to move to bespoke tooling but would rather use standard machine set ups. For me the tweaking will have been ONLY in the “on strip” chemistry.
So – summarising: Once the Test strip is agreed and finalised, the LFD can be finalised but that step shouldn’t be very long.
Thereafter Transfer to Manufacturers can take place along with validation (IQ,OQ,PQ etc)
Hope this makes sense – come back with any specifics.
Ophidian
Hi BBN, I think the comment on demand exceeding supply was from an interview, similarly I can’t recall when, but I remember it distinctly. You’re quite right that the latest RNS neglected to mention Cytiva manufacturing, but as you’ve said they don’t need to transfer anything so what wasn’t said is just as relevant. There was some discussion on here regarding their ongoing involvement, your post makes a lot of sense as the original partnership RNS said they would be manufacturing.
Good post BBN and hopefully this opens up some constructive conversation finally not the bickering around rampers/derampers that has sadly taken hold of late.
I fully agree with your statement "This was clearly marked as end of June on the slide, which is why I questioned the 24th June announcement being the actual update, as opposed to a step along the way. I could not logically conclude that such a video would call out the transfer to manufacturers as end of June, when the very next day this was going to be undermined."
Having seen the carnage to the sp perceived delays can cause (as there have been no genuine delays so far) it would be crazy for AS to put something very specific in a presentation, to release an RNS the week before and miss that completely. I think the RNS was just a little clarity for the market on progress given the technical nature of the labroots panel and the presentatin was a "dummies guide to S&S" so to speak. Surely the market needs some background to the S&S RNS as I would think this will be a very technical piece that not all would understand in great detail.
Give people a quick lesson on what the terminology means and what are acceptable numbers and this gives people a much clearer understanding of the RNS. Or is that just me being optimisitic?
Hello Ophidian, I have a few points/queries, if you would care to entertain them.
The latest update from AVCT stated "work continues now to refine the test strip design, optimise its performance and get the best detection limit possible."
However, they were clear that the LFT is entering the optimisation stage.
In the diagnostic test video released by AVCT last week, the wording on the Antigen Test Development Pathway slide was ;
"when satisfactory laboratory performance has been achieved, the design will be transferred to manufacturers"
This was clearly marked as end of June on the slide, which is why I questioned the 24th June announcement being the actual update, as opposed to a step along the way. I could not logically conclude that such a video would call out the transfer to manufacturers as end of June, when the very next day this was going to be undermined.
In addition.
The 24th June update is clear ;
"Following the optimisation of the lateral flow test by Cytiva the design will then be transferred to manufacturing partners in the UK that are currently being put in place by Avacta."
I appreciate that optimisation is an ongoing process and that optimisation in a week would be very quick but in order to begin to transfer to the manufacturers for the commencement of "validation batch manufacturing," there surely needs to be a design freeze and that freeze comes after optimisation and AVCT are stating that commences end of June.
In all of this I am still a tad stumped as to Cytivas role. It was clearly stated in earlier updates (need to dig it out), that whilst Cytiva had large capacity, it wouldn't be big enough to satisfy the expected demand. However, that does not mean that they won't manufacture. That lends itself to the argument that Cytiva have indeed produced the first pilot batches and can therefore advance their version of the test without delay. I see no logical reason to deviate away from that plan. So front end real patient sample testing should not require tech transfer or as you have stated, it can be done in parallel.
12th June Proactive presentation ;
"we anticipate having prototype devices by the end of June that will have been tested with model systems and be ready for testing with human samples"
"it is an important milestone of demonstrating that the test works with real patient samples and then going into a phase of manufacturing, manufacturing a number of batches to allow us to go into clinical validation."
So everything pretty much supports what you are stating, I am just querying the tech transfer point and optimisation time period because for me, its still be called out as end of this month, which sounds a tad quick, although the 24th June update did say ;
"we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers"
Thoughts welcome.
I've sold a massive chunk, not worth watching the profits fall like that.
The guys in charge seem to be very happy with progress -good enough for me !
"Dr. Alastair Smith, Chief Executive of Avacta Group commented:
"I am delighted with the progress made by our partners at Cytiva and very encouraged by the positive data from the first test devices. We now need to optimise the test performance to achieve the best possible limit of detection as this will ultimately play a significant factor in determining the clinical sensitivity of the test.
This is a really positive step and we aim to have completed the optimisation very soon so that we can begin the transfer to manufacturers. I will be updating the market on progress in due course."
Klaus Hochleitner, Global Lead, Technology Product Specialist at Cytiva, commented:
"I am pleased that the test development has progressed from a working initial design to now focussing on optimising the test as much as possible. The Affimer reagents have worked well in lateral flow test strips and we are very encouraged by the initial data."
Thanks Ophidian. That is most helpful. I was expecting a RNS sometime this week but, having read your timeline I certainly won’t panic if one isn't forthcoming.
In any event I’m in for the long haul although it’s interesting keeping abreast of the different agendas evident on this board. The bottom feeders and scavengers won’t be getting my shares anytime soon, that’s for sure!
Great summary. Having been in the industry it’s only ,message , when all’s done.
The discussion recently online was typical and inter supportive...conclusion soon and certainly positive . The completion of the LFD challenge is just that.
Apparently some (contact by DM) thought this post lost - it's not but here it is again for those who are interested and couldn't find it:
I thought it might be worth highlighting what is and more crucially what is not in a company's hands at about this stage in the proceedings.
7. Additional batches made again at pilot scale to clinical standards for first time clinical evaluation. Supplied Wk3/Wk4 June Time to complete 21-28 Days
8. In parallel with clinical programme; Scale up to production scale. Include Tech transfer and validation batches (again put on stability to generate data)
9. Evaluate data from clinical programme (establishes the Selectivity and Sensitivity of the test) July Wk.2s/wk3
10. Generate the Regulatory dossier including clinical data, stability data, development data and supporting data from early designs Wk2/wk3/wk4 July
11. Submit Regulatory dossier and if not already ongoing be manufacturing launch stocks 1st August
12. Get approval Wk3 August
13. Start selling Wk3/4 August
Number 7. After the samples have been supplied for clinical evaluation how quickly that is completed is not usually within the control of the company. Accountability is passed to a clinical programme manager (doctor) who independently executes the evaluation according to agreed protocols.
Number 8: = mostly in the company's hands but of course they are at the mercy of their partners here too. Plus Stability testing so far I have never found a quicker way to produce a month of stability data than wait a month !
Number 9 : They will have probably already built the evaluation model and it is just a case of plugging in data as it arrives. This will not be all done at the end. It will be build as you go.
Number 10: As with number 9 - build as you go along. Slot in data as it becomes available. In my experience the longest part of this process is data checking what is in the dossier back against raw data (but it has to be done). The discussions will all be written as no surprises are expected in the final results. As soon as the evaluation is complete and slotted in and the final stability data to be included on submission is there.....
Number 11: - put it in - then get on with making launch stock and probably doing the updates to submit during review as additional stability data becomes available. It is also possible that a larger clinical data set might also be updated during review.
Between 11 and 12 the timing is completely out of the company's hands provided they respond nimbly to any requests for clarifications and additional (supporting) data if they come in
Number 13 - isn't usually delayed once 12 is in.
We are entering a bit of a quiet time in the process - don't be fooled that nothing is happening - it is - there is just nothing to RNS. Some may try and pray on this hiatus. You have been warned.
I'm happy to answer questions on the process from genuine contributors -
Ophidian
I wish Sir Al had used the phrase ‘as soon as possible during the summer’ originally, rather than the phrase ‘a few weeks‘ which raised unrealistic expectations. They’re no doubt working this weekend as they were previous ones, they’re working as hard as they can and it’s just a matter of time before we get the news we’re all eagerly waiting for. Knowing Awacta maybe a good surprise or two on the way too.
Timster, I’m expecting very regular updates, I was surprised that shipping the affimers ended up in an RNS.
Hi Ophidian
Please don't stop posting.
Most here are just developing hind limbs.
Obvious in context to investing.
GL to you and us all.
I would not expect to see that RNSed @Timster. And not wishing to be pedantic - they are not doing a Clinical Trial. It is a clinical Evaluation of a Diagnostic Medical Device.
Ophidian
As you said earlier though it's possible during this quiet period for avacta they will put out a few more RNS's for BAMS, manufacturing partners and blocking therapies.
Shirley they will RNS entering clinical trials too that must be a major milestone
No questions from me, just a thank you for your detailed posts, much appreciated. The speed at which this is all being carried out is incredible, how anyone can comment they are behind or taking too long is beyond me! Clearly have hidden agenda's...