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Take lfts out the picture and they have FA to talk about.
Personally i`m looking to trial news and results and a nice Christmas.
You seem very desperate to discredit a company that you claim to have a holding in. Why is that ndn, it certainly smells eggy?
No conspiracies here sorry, as much as you’d like to believe it, or push the falsehood. You are beginning to sound like AgentB.
AS has said on the record that the CE marking for home use was underway in April, so that’s my starting position (it may have kicked off even earlier than this). Add to this the assertion that medusa19 will have been pushing this through as hard and fast as they can. They have a far larger stake in this any of us. No reason to find some alternative narrative here, or jump through hoops to discredit their motives.
Times up eggy. Soon you will be able to rejoice with the rest of us.
P.s. as an aside, AS was not making up the timelines. This document states up to 9 months to register a medical device.
https://www.regdesk.co/things-you-should-know-before-registering-your-medical-devices-in-spain/amp/
Well, I’d say that a lateral flow test isn’t the most complicated of devices, so let’s just say 6 months shall we ;)
Agree Mowzerrocks, the negativity and lack of objectivity gives away the agenda of some.
Yes, they are under an NDA with medusa19, this has been stated by AS himself. We unfortunately won’t be getting the day by day details as a result.
He did tell us in the April 22nd webinar that the process was already under way in parallel at that time. Obtaining a CE mark is a process, with the submitter working together with the notifiable body to ensure that the product usability and instructions are fit for use by lay persons. There will be as many rounds as required to reach the required standard, with an associated delay after each resubmission (likely made worse by the pandemic). I will take this to mean that the process has been underway for at least 6 months. I have no reason to disbelieve what we are told.
From AS’s language, I will interpret it that medusa19 are now reaching the end of the process, with the final tweaks having been submitted. It is now down to how long these will take to pass through the notifiable body.
Just for those who might be interested, I think it is highly likely the notifiable body they are using is in AEMPS in Spain:
https://www-aemps-gob-es.translate.goog/productos-sanitarios/organismonotificado/?_x_tr_sl=es&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=nui,sc
Medusa19 have previously been linked to this notifiable body with the saliva test.
It is also fanciful to assume negative reasons. There is a lot less specific information being released by the company. One could easily imagine that the high volatility in the share price is something that management would prefer to avoid.
High volatility certainly attracts an element of sh1 tty ‘investor’ types… this BB can attest to that.
I would imagine not saying when something was submitted could equally have something to do with the 3rd party shenanigans last time as well…. !
We will know when we know… until then we have actually had a fairly stable SP in the 105-130 range.
Icecool, I take it the usual group attempting at deramping. As you say, pro use was in avactas hands. For HUA, AS has said numerous times that it was not for him to provide updates. All he could advise was that they were doing excellent progress. We will be advised on HUA only when Medusa has concluded and ready to tell the market
For a start Avct not submitted home use it’s Medusa and they have an NDA in place so non of us know exactly what’s going on. Although we can assume that Medusa won’t be sitting back on any private LFT market, UK or EU so I would imagine things will be escalating at pace to meet demand!!
Gla
Turtle, slow by name, slow by nature.
Really? I heard mid Sept, but timelines were never a speciality…
I was reliably informed end of September from someone who told me he has access to information and was generously sharing it
Oh hang on......
I have noticed you struggling a bit before, and there were more than 10 words again this time. Another buffer overflow doggy? :)
Watch the same person here now
Priceless
Complicit in what you complete and utter moron? If you can’t comprehend the posts then stick to reading your Mr Men books…
Complicit
That’s the post
Absolute losers
Accept GJE, on the 30th of sept ie very, very, very recently, (see what I did there), AS said many, many, many months in normal times and these are not normal times, the inference being longer not shorter.
I accept neither of us know but I struggle to put the spin you did on it.
I see you are on the weekend shift wyndrum :)
“AS said nothing of the sort…”
Back to the dictionary for you, note the use of inferred. This implies that I am making the deduction. All the quotes are taken from the presentation verbatim.
The timelines also stack up. The original clinical validation results were RNS’d on the 10th May, and the lay user study, if scardy and Robby are to be believed, took place on the 12th May. If these were submitted in May/June, then that would give us 5 months since all that took place, which fits with the delays as reported by ncyt.
Anyway, I am not presenting this as fact, merely providing a few dots that people may or may not wish to join up.
GJE, "it could be inferred that the submission has already been with the notified body for some time, otherwise AS wouldn’t be hopeful at that point that it was close. This was made over 2 weeks ago, so there’s every possibility, especially given that the rumour mill is at full tilt, that it has been achieved."
AS said nothing of the sort, if anything it read he was managing expectations that it was not around the corner.
"but I think you’ll find that notified body review can take many many many months even under normal times, so making the progress that has been made is not in my view taking a long time, so I sincerely hope we are close to having that CE mark, but we are in the hands of the notified body at this point.
So yes, he "hopes" its soon, but having flagged and emphasized how long it can be and not just months, or even many months, but many, many, many months which suggests to me its not imminent, (otherwise why make such a song and dance about how many, many, many months it takes under normal times and then reminds us all that "we are in the hands of the notified body at this point.".
To me ,imo, this simply strengthens the likelyhood of this not happening in the next few days as we are not in normal times and far from speeding things up , the opposite is happening ala NCYT said there were delays in getting tests pushed through by 6 months.
It will be when it will be, but I did not read the way you did that's for sure.
Given the statement “notified body review can take many, many, many months”, and the statement that AS is sincerely hopeful that they are close, it could be inferred that the submission has already been with the notified body for some time, otherwise AS wouldn’t be hopeful at that point that it was close. This was made over 2 weeks ago, so there’s every possibility, especially given that the rumour mill is at full tilt, that it has been achieved.
Q: When is home use authorisation expected for the AffiDX LFT and can the company provide clarity as to to what is specifically involved in this process that is taking so long?
AS: Yep, it is really important so I obviously want to answer this question which a lot of people have asked, so first of all we’ve talked about the regulatory process before, so just to recap, there’s an additional study called a lay user study, which really focuses on the usability of the test, it’s not a clinical validation it’s the usability, that data which medusa19 carried out is combined with the technical data for the performance of the test itself, and then that full technical file was submitted to the notified body for review. Unlike the self declaration for the professional use test, the CE mark for the self test is conferred by the notified body, so we have to wait for that.
Medusa19 has led that process and as I said in the presentation they’ve done a really outstanding job. The questioner, i don’t know who it is, is suggesting that it has taken a long time, but I think you’ll find that notified body review can take many many many months even under normal times, so making the progress that has been made is not in my view taking a long time, so I sincerely hope we are close to having that CE mark, but we are in the hands of the notified body at this point.