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Its sad really how much childishness there is on these sites between supporters of competing companies - like our conversations and debates have much effect - chill - relax - im sure theres plenty to go round - and if you are not invested in ODX and you cant play nice - go back to AVCT chat - thanks
Spot on sjpw, welcome to the realm of Antigen testing :). To answer your question, if tech transfer has nor started then it is not a validated batch that can be used for CE marking
Bubba seriously do some research. Mologic will CE mark it first, they have their own manufacturing. We know ODX have to tech transfer before they CE mark it under Visitect brand
Antigen is clearly more complex that antibody to produce, so TT of an LFT antigen test will take longer.
Do you know (not hope or believe) that the current trials are of LTFs that are part of an initial validated (in so much a certified repeatable) production batch?
CE marking isn't just about the end product. The WHOLE process has to be validated including manufacturing as the batch produced AFTER tech transfer will be the standard for the millions produced thereafter. I repeat again CE marking CANNOT be acheived before tech transfer.
Even the 10000 units produced for CE validation have to be tested against the PCR standard. Those that think this takes a couple of weeks need their head checked.
The live trials are part of validation. To CE mark the test it needs independent approval, likely from LSTM. This can be done very quickly once the appropriate performance measures are met
Mologic will CE mark it themselves first. FACT. Look ant the antibody test order of events. As soon as Mologic CE mark the test then we will rerate, as although tech transfer hasn't taken place it is validation that the test is 4-6 weeks away from being in production.
Mologic can - then i believe its tech transfer then we CE mark? And it sprobably easier once one CE mark is done as they have a base line But ill welcome confirmation - thats what i heard
You cannot CE mark a LFT BEFORE Tech Transfer
That was the timeline Colin just indicated in the presentation - sounds like the field testing is pretty advanced and he has had conversations with Mologic suggesting they are very positive
@Merchantbanker - We'll find out very soon either way-- either you or I will have egg all over our faces in a few weeks & will be eating humble pie as regards to advice and facts.
Actually MB, I'll ignore your patronizing. Yes, I understand TT (as a non scientist as I assume you also are). I've been invested here and with AVCT since late spring.
What you assert is that Mologic will have completed their certification of manufacturing by the end of November - yet they are still evaluating their prototype in the field according to the ODX RNS this morning.
Seems like an unrealistic timeline from evaluation to manufacturing set up and formal accreditation to transfer to other manufacturers.
The presentation slide shared yesterday suggested a next generation test with combined antigen and antibody. This has been mentioned in the past in relation to UK RTC. Perhaps the Mologic test once CE marked could go the other way and spread through the consortium members. Fact is Abingdon and BBI had no place in the Antigen market and were desperately trying to get take up for their lateral flow capacity. They had nothing to lose by working with Avacta and it probably suited them for entering government negotiations as negotiating when you only have one product or source of income is never ideal.
"Regulator
You’re wrong.
Mologic intend to CE mark in November.
ODX will commence tech transfer soon after, could take 6-8 weeks but best case is 4 weeks.
Which takes us into Xmas / New year. Then ODX would CE mark test before sales.
I know this because I asked ODX."
How does this conflict with what I said?
"Mologic will produce and CE mark. Then there will be an MTA, three batches run (each of a few hundred tests) for validation and then ODX will CE Mark under the Visitect brand. This could be completed by Christmas, given how slick ODX have become with MTAs/validation/CE marking."
If you're going to argue at least have a point...
@sjpw
I don’t need to answer that question, just ask the avacta brethren. They outlined the avacta bbi agreement as evidence of timelines.
You’re in avacta. You need to ask them why it’s 3 months to BBI. Not ODX pal. Our TT is 4-8 weeks. Closer to 4 than 8.
I know this because I heard Colin answer the question.
Myologic LTF saliva test end of this year or beginning of next.
I think they'll sell like hot Scottish Hot Cakes.
The other bit I like is the ABC test supporting Vaccine rollout out.
sjpw - do you even know what tech transfer is??? Tech transfer is a process that has to be completed by each manufacturer. It's not a one time fits all process. It's taking the manufacturing process from the developer or lead manufacturer and transferring it into your own manufacturing facility with validation batches.
@Safy, you said "ODX TT in ideal conditions is 4 weeks!!
Avacta test in ideal conditions is 3 months minimum"
Some facts please to back those statements up, if you can (to include what you mean by "ideal conditions").
I hold both stocks. Looking at it from an odx shareholder perspective I dont care whose antigen they manufacture as long as it sell like hotcakes and for a decent margin. What matters in these terms is that its a quality test that they manufacture. They are in a great position of being signed up to produce one already and if the other proves to be better or comes sooner they could sign up to manufacture both. Covid will be a global problem for an extensive period and if one or both of the tests is really good then odx will be very busy, expanding and profitable. That's why I have a significant holding along with the fact that Colin has told us that as covid testing wanes otjer tests they produce will be waxing and thereby taking up what would otherwise by slack and keeping the company growing in revenue and most likely profit.
Spot on Safy
Regulator
You’re wrong.
Mologic intend to CE mark in November.
ODX will commence tech transfer soon after, could take 6-8 weeks but best case is 4 weeks.
Which takes us into Xmas / New year. Then ODX would CE mark test before sales.
I know this because I asked ODX.
There you go with that intentionally biased logic again. You said "If it was avactas wouldn't that take the same amount of time for TT?". Avacta have been in TT for over 2 months, so no.
Don't know why you are so negative to Avacta (you hound their board at every opportunity). It doesn't matter whether it is Avacta or Mologic, or both that ODX manufacture.
Either way
ODX TT in ideal conditions is 4 weeks!!
Avacta test in ideal conditions is 3 months minimum. And add a month on for being realistic because it’s hard to TT something which doesn’t exist.
"Tech transfer completed by Christmas, then 10000 LFT units produced for CE marking, which need to be tested against the PCR standard and finally getting the CE mark if they pass. Looking at end of Q1 methinks for a test to be on the market."
Err... no. Mologic will produce and CE mark. Then there will be an MTA, three batches run (each of a few hundred tests) for validation and then ODX will CE Mark under the Visitect brand. This could be completed by Christmas, given how slick ODX have become with MTAs/validation/CE marking.
How can you say tech transfer takes 4 weeks so it must be Avacta's. If it was avactas wouldn't that take the same amount of time for TT?!!?!! The desperation from AVCT shareholders for every mention of Antigen tests to be theirs is understandable when you have a £450m valuation with no test.