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you numpties clearly haven't been paying attention at the back there have you, too busy picking your nose and throwing paper aeroplanes. The home use approval does not involve any clinical validation, and focuses instead on a usability study, so PD has jack all to do with it. The process could end up going through a number of iterations, yes. However, the message of "coming soon" on the medusa19 website would suggest the CE mark will land imminently.
You lot are out in force today, so clearly concerned about what is to come.
Ophidian posted last night: "As I shared on here expected to be taking orders by mid september and supplying by end of september. Question is what went wrong ? Either way he expectation now is for the coming week as everyone is aware."
Having asked the question "what went wrong" , I would have thought with his contact(s) he would have the answer? Because if he doesn't know what went wrong than how can he know its only a 3 week delay?
The other thing that jumps out is: "Either way he expectation now is for the coming week as everyone is aware."
If everyone is so aware that the SP will be 250p by Friday then why hasn't it gone up today? (If by "everyone" he is referring just to this BB, then again more proof that posts here make no difference to the SP, which should reassure some.)
Ginge,
testing is a minor cost? really? a company with a 1000 employee's testing one per week at £5 per test is £5k a week or £250 per annum. To get what, 5 or 6 people. And of those half dozen some may be asymptomatic, so no time off, the others may have a few days off. which is cheaper than 14 days isolation is it not? The cost benefit analysis does not look attractive.
And I am not bashing the stock, nor am i "worried" but we need to be objective as we can about the market and its potential.
How can we know the demand when we have no test for sale? (We have business use already and have had for months, so where are the sales (in any number?) with all this demand? Assuming we get approval next week (which who knows), how many other tests will be available?
So no ,I am not obtuse, but this is yet another "is it us" moments and frankly if you have not learnt by now that history is not on our side then I would suggest you have your head in the sand.
We need HUA, wee need to see some sales with profit margins otherwise your view is of no more relevance than mine.
On the assumption that the notified body is Agencia Española de Medicamentos y Productos (AEMPS), then it is interesting to note that there is already a relationship between the FDA and AEMPS in the form of a mutual recognition agreement for Pharmaceutical inspection.
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra
Not exactly the same thing, granted, but having this in place can only be a positive thing when it comes to any dealings with the FDA.
Utter nonsense. We do know the demand, we do know the competition, we do know the profit margin.
Testing is a cost - a minor cost compared to paying an employee to isolate at home rather than produce. In a single word essential. Or if you prefer a bargain.
You are being deliberately obtuse and disingenuous. Foolish of me to engage.
worth remembering too that CE mark is a precursor for EUA in the USA from FDA. (Medusa USD currency option.....)
Ophidian
wyndrum: to worry about unknowns no-one would invest at all. It's called taking a risk, indeed a calculated risk. Ever considered the building society?
Well if we're going to be consistent - everyone bashing this stock is forever reminding us how we have to add significant time periods onto any Alastair Smith estimate of how long something will take...
Therefore, if he said testing will last 2-5 years - then we can reliably believe that it is more likely to be 5-10 then can't we?
CO, indeed, and AS said as much in the Q&A session in the most recent presentation, that Avacta is looking at building market share in many territories pending approvals, and anticipates demand will be here for the foreseeable. Once the Home Use CE mark is in the bag, that can only help with attaining these approvals. Another very interesting remark he made was potentially licensing out the LFT tech.
Ginge, we don't know the demand, we don't know the competition, we don't know the profit margin, we don't know how long testing will last (remember AS said 2-5 years ). Given he would say that wouldn't he, nevertheless most commentators have expected some sort of shelf life on this test, as opposed to it lasting for ever.
I posted 6 months ago that I felt AVCT were getting ready for the "next" one, rather than this pandemic
What would make testing (broadly) redundant? Better vaccines resulting in less serious outcomes and potent anti virals for the more serious reaction.
Testing is a cost for whoever pays for it whether its companies, govt's or the general public. If ultimately catching Covid results in the vast majority at worse having a few days off work with the equivalent to a nasty heavy cold, and for worse reactions there are good treatments available, then the need for testing could rapidly diminish. That's why every one seems to have put (albeit varying), timelines on the necessity of testing.
How obtuse. You are aware of changing testing requirements in the UK at the end of this month ? You are aware that Medusa are simply awaiting HUA which is today closer than it was tomorrow ?
In the short, medium and long term AffiDX will sell as fast as they are made.
Try harder
That is a good point for the current state of the market. But do you think we are the only company scaling up to sell into the shortage of LFTs? I’m thinking of the longer term market.
I try and ignore you but what an absolute agenda driven bore you are.
Ginge, a shortage of LFT's has not so far through the AVCT business channel resulted in RNS notable sales, so I am not sure the relevance of the remark. Likewise until we have HUA it simply rubs salt into the wound to keep saying what the demand is with no domestic product available.
I think you are missing the main point which is that there is a shortage of LFTs. They will all sell - simples.
Muller
Their Saliva isn’t a antigen test and why haven’t they got the statement next to their saliva test on the website.
Look this one statement says it all:
COMING SOON - Consumer Test Kits
These test kits will be suitable for individual and home use, as well as workplace and healthcare professional use.
These will be made available as soon as possible after the required approvals have been obtained
And we wait but with a lot more confidence .
In the current setup, the consumer is not trusted to do their own test and report an honest result - which is why NHS free tests can’t be used. Hence third party suppliers providing antigen tests with a £20+ markup to provide the service. Unless this setup changes, it would be hard for the airlines to mandate use of a specific test.
I think the sort of customers that will care about test quality is companies testing their own employees, and conscientious people who want to test themselves before going out, especially if seeing vulnerable family and friends.
Maybe another group would be older people who want to know if a respiratory infection is covid or not, so they can watch for warning signs of breathlessness etc, and seek out appropriate treatment early.
British airways using British designed and manufactured LFT's its the perfect fit
They have submitted their saliva test for home use also.
I wouldn't be surprised to see the airlines offering an all inclusive price with the LFD provided and high volume deals done with suppliers.
Ophidian
Check out Medusa delivery & product costs policy currently for Rapid Saliva Protein Test ( Not Avacta ) but gives an indication of their possible international selling reach .
https://www.medusa19.com/en/delivery-policy/
As you know vegas, notwithstanding my general disappointment with our LFT, the TI was always the one global area that we could still have huge sales through.
It will be interesting now because we will be one of many tests available and from some big players too I imagine, so some folk might buy on a "trusted" brand name and not potentially trust the stats on our packet. (Hopefully thats when the marketing company show their worth.)
Still all to play for but I think its a higher risk than before when it felt AVCT were the one and only LFT player available.
Still too many unknowables, so we wait a bit longer.
But thanks for the courteous response
On main Medusa site they don’t mention the saliva test as a kit at all and never have, but Avacta mention theirs as a Kit.
The link I put on last night mentions consumer test kits.
We are very close now…..
https://avacta.com/diagnostics/products/
Ordering information
Product code 11711125
Product name AffiDX® SARS-CoV-2 Antigen Lateral Flow Test
Pack size 1 carton containing 25 test kits
Kit contents
25 lateral flow devices
25 buffer capsules
25 sterile swabs
25 swab extraction tubes
1 Instructions For Use
https://shop.medusa19.com/en_GB/taxons/covid19-tests?channel_type=default
Tests
COMING SOON - Consumer Test Kits
These test kits will be suitable for individual and home use, as well as workplace and healthcare professional use.
These will be made available as soon as possible after the required approvals have been obtained
And just to add travellers can be as fickle as investors
By that I mean if there were to be an outbreak on a flight a lot of travellers wouldn't fly with that carrier
That why I think the airlines will have a bit of clout