Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Yes, Livedata your perceptive intuition is spot on! As Wm Blake once sagely commented, “We are led to believe a lie when we see with not through the eye.”
Whilst I have apriori knowledge of the limitations of these governmental type quangos, I nonetheless reminded myself of the seeming meaninglessness of the MHRA’s mission in life bestowing their conferred blessings on medical practices.
In their supposed role as the UK’s regulatory gamekeeper of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness, they fall way short and lack any legalised enforcement teeth. All you need to do to get the picture is walk down Oxford Street and purchase a Covid-19 confirmatory test for upwards of £60, which is no better and probably even less reliable than the disreputable Innova test. They purvey their wares totally illegally and yet get away with it scot-free!
Meanwhile, the more ethically inclined companies such as Avacta, end up jumping through every hoop imaginable to who knows what end.
Perhaps you are right Tim but surely there is no harm in giving them a sharp kick up the arse?
Incidentally, they responded immediately with a stock email response, (see below). However, what is interesting is their reference to "we endeavour to respond to enquires relating to Covid-19 on a priority basis."
"Thank you for your email to the Devices Regulatory Team. Please accept this email as confirmation of receipt of your enquiry. For previous enquiries you may have received a separate, direct acknowledgement to your enquiry – please note that this will no longer be the case and this will be the only acknowledgement.
Your enquiry will be passed to one of our Regulatory Team who will respond to you as soon as possible. We aim to respond to all enquiries within 18 working days from the date of receipt. Straightforward requests are likely to be responded to more quickly and we endeavour to respond to enquires relating to Covid-19 on a priority basis. Enquiries requiring a detailed response or contribution from a specialist are likely to take longer."
FYI, I submitted this email below today to the MHRA for a response.
To: 'devices.regulatory@mhra.gov.uk'
Subject: Avacta Group plc
To Whom It May Concern:
I understand from one of your colleagues, Hanna, with whom I spoke today, that I should direct my specific inquiry directly to yourselves.
I am interested to find out about the outcome of Avacta’s ‘Declaration of Conformity for CE mark’ of its AffiDX® SARS-CoV-2 antigen rapid test for professional use, which was submitted a week ago to the Medicines and Healthcare products Regulatory Agency ("MHRA") through the Group's partner Mologic Limited
Their data submission was combined with stability and other performance data and submission of the Declaration of Conformity for CE marking of the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use.
The Group advised by way of an RNS on Monday 10 May 2021 that they were expecting to receive confirmation of the registration of their AffiDX® in-vitro diagnostic device from the MHRA in the coming days, which will allow the Group to immediately place the test on the market.
Please can you advise when this submission is likely to be granted registration approval from the MHRA and where on your website you will publish this confirmation?.
FYI, I tried today to access the MHRA website as follows: https://aic.mhra.gov.uk/era/pdr.nsf/name?openpage&start=1&count=200
However, I was later advised that it is not the right place to find registration confirmation of this specialist Covid-19 type of device. In any event, I also understood that the website given above is refreshed every Monday but I was unable all day today to find any newly published ‘Manufacturers By Name’ information or relevant documentation whatsoever.
I look forward to hearing from you on the above at your earliest convenience.
Hi Again Mr. Spacetomato,
Let me respond by firstly assuring you that I am by no means a ‘deramper’ as you suggest nor would I waste my time in partaking in such a derogatory pursuit.
FYI, I have been an avid follower of Avacta for well over 12 months already and I’ve been and still am a relatively heavy investor in Avacta shares ever since. At the outset, I would have classed myself as a total novice regarding the pharmaceutical industry but by today I can modestly claim to be half of a world’s expert on the subject, as well as a devout evangelical spreader of the Avactian good word.
My reference to a waste of space was perhaps a failed attempt to bring some light humour to my honest appreciation of your contribution to my post. Although you may have misunderstood me and responded a tad suspiciously, For my part, I take no offence and look forward to a developing companionship.
Yes, Mr Spacetomato, I understand that way back in 2008 DARPpins, were heralded as a new generation of therapeutics. Although at that time, taken together they were seen as a prominent member of the next generation of protein therapeutics with the potential to surpass existing antibody drugs. However, they don’t appear for whatever reason to have since materialised as effective ideal agnostic, antagonistic, or inhibitory drug candidates.
Meanwhile, thanks for your much-appreciated response to my redundant/waste of space (excuse the pun) question.
Apart from Avacta being at the forefront of the introduction of a novel generation of Affimer® affinity reagents, which have the capability of competing and eventually replacing the highly lucrative global antibody pharmaceutical markets estimated to be worth in excess of $50bn annually, are there other equivalent competitive proteins/processes, which would suffice equally?
In other words, are there any reasons to claim that Avacta’s human stefin A protein is exclusive in any way to other potential candidates? If so, will the eventual winner be governed by the same vagaries associated with the infamous VHS Vs Betamax wars?
FYI, I respectfully refer everyone to a recent enlightening Lancet comment (see link below) on the subject of saliva-based mass testing. Whilst it may not be practicable to switch horses in midstream, there certainly is a realistic longer-term opportunity for it to be adopted as a standardised, inexpensive, and broadly implementable saliva-based method, which could make frequent, comfortable testing for SARS-CoV-2 a reality for communities globally.
Adam Finn, who is a member of the British Department of Health Joint Committee on Vaccination and Immunisation (JCVI), tweeted on 27 April - "Dump the swabs! Use saliva. Non-invasive. Collect it yourself. AND you can measure antibodies in it too."
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00178-8/fulltext#.YIhtDtqdpP8.twitter