Member Info for Bella6532

Tomorrow?

Strangy83...its all there if you DYOR...I've given you some pointers...

Mr. A...not disputing your memory...I didn't see it myself so must have missed it.

Orphidian...over to you...you're much better at sorting through this sort of stuff than me...thanks in advance.

Mr. A ...No I haven't posted it before, but it could have been a generic response sent to other MPs who might have forwarded the cut and paste letter on to him. I must have missed it if someone else had a similar response and posted it up on here.
I was just linking the new open consultation with the letter as the two go hand in hand. As the consultation isn't due to close until the end September and he states they hope to complete regulatory approval within the coming months which is needed after successful completion of validation 3a, I think we might be looking at a longer timescale then possibly anticipated. It's certainly one to ask Alastair about having received a bit more info directly from the Parliamentary Under Secretary of State for Innovation (Lord Bethell).
And is this what is holding up consumer self-testing approval and Govt contracts even though we are now listed.
and how does this fit into the aforementioned picture:

'SARS-CoV-2 Lateral Flow Tests throughout the UK.
Medusa 19 are one of multiple selected suppliers to this Framework Contract which will run for the next 4 years and has a value of up to £3 Billion.
This Framework Contract allows the provision to all UK Government Departments and Trusts across England, Scotland, Northern Ireland and Wales subject to access agreement signature and Schedule 6 pricing, to supply the Rapid Saliva Protein Test (RSPT) and Avacta’s professional use AffiDx SARS-CoV-2 Antigen Lateral Flow Tests.
The Medusa tests detailed above and other parties lateral flow tests are now available for purchase by various government departments subject to their demand requirements.'

p3
The Secretary of State, having assessed the above criteria and his overarching objective to safeguard the public health, notes the minor risk to the supply of COVID-19 tests but believes this is negligible in regard to tests of sufficient quality to be an effective tool in identifying infections early. The removal of poor quality tests is a more substantial benefit to the protecting public health.
The Secretary of State will continue to assess the matters set out in section 15(2) to (4) before making any regulations under section 15 to give effect to the policy proposed in this consultation.”

mmmm!!!!
This one sentence stands out....'The removal of poor quality tests is a more substantial benefit to the protecting public health.'

On 8 September, I received a letter from Lord Bethell at the DHSC and in this letter he directed me to the above link. This letter was in response to the cut and paste letter many of us sent to our MP's regarding the Innova test. I sent it to Owen Paterson my MP who obviously forwarded it directly to Lord Bethell who replied to me via Owen Patersons office. The opening line being:
'Dear Owen
Thank you for your correspondence of 16 July on behalf of your consituent, Ms XXXX, about COVID-19 testing. I apologise for the delay in replying.
I appreciate Ms XXXX's concerns and thank her for raising this issue with you.
We are committed to boosting UK manufacturing...'

and closed with

'....A number of UK products have been through Porton Down validation and have passed 3a validation. None of these has yet achieved regulatory approval to allow them to be used in the settings we require. However, work is underway to secure regulatory approval for the suppliers of these products, and we hope that this will be completed successfully in the coming months.
I hope this reply is helpful
LORD BETHELL'

Everything in the middle just covered what we already knew...

So there you have it chaps...now make of that what you will...

page 2
Any impact of this proposal on the safety of the COVID-19 tests will be positive, since it will ensure that only tests meeting a minimum standard of accuracy are available on the UK market. It is therefore considered that this proposal does not create any risks for the safety of medical devices. The rigorous validation process set out above ensure test of are of sufficient quality to protect the public health.
The availability of medical devices within the scope of this policy
Creating a new regulatory standard will limit those tests that would not meet this standard from entering the market. This in theory will reduce the number of tests available to the UK market. However, in reality we are removing tests from circulation that could be a threat to public health due to their higher than tolerable propensity to give false results. Given the impact false negatives can have on the public health as users can unwittingly infect others having been given the confidence not to self-isolate by a poorly performing test justifies removing them as they can in reality be worse than useless and present a harm to the public health.
I do not believe the type of validation we are proposing nor the fees or time the process will require, will act as a deterrent to manufacturers of quality tests, given both the size of the businesses involved and their experience with dealing with such processes.
The creation of a highly respected validation process could create a market efficiency with high quality tests seeking the UK market and poor quality tests self-allocating themselves out, or striving to raise their standards to a sufficient level. In either scenario we the supply of high quality tests is unlikely to be impacted.
Whether the United Kingdom is likely to be seen as a favourable place in which to: research the medical devices within the scope of this policy, develop medical devices within the scope of this policy or manufacture or supply medical devices that come within the scope of this policy
As set out in the qualitative analysis in the private market section, I do not believe a validation regulatory regime of this kind will deter any business from researching or manufacturing COVID-19 tests in the UK.
It may dissuade suppliers of low quality tests from bringing stock to the UK, however I do not consider this to be a negative impact but a positive as we wish to focus our market solely on high quality tests.
Good regulation will give business clear and consist rules. This is something all businesses rely on. I fully intend for the resulting SI to be just such an example of good regulation.
Cont..P3

https://www.gov.uk/guidance/lateral-flow-validation-prioritisation-criteria-for-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens
Open consultation
Validation of COVID-19 tests: laboratory validation
Published 2 September 2021
Next steps
Following the closure of the consultation period on 30 September 2021, DHSC will analyse the responses. If the decision is taken to introduce a second laboratory review stage to the mandatory validation process, we expect to move quickly towards laying secondary legislation. The UK government response to this consultation will follow in due course.

As a COVID-19 test is a medical device used for diagnosis, the UK government proposes using the Medicines and Medical Devices Act 2021 (MMDA) to amend the Medical Devices Regulations 2002. The amending regulations would establish a mandatory second stage of the validation process, which will require manufacturers of COVID-19 tests to apply for independent validation of the performance of their tests, via desktop review and laboratory review, for these to be placed on the UK market.

This will place a legal duty on manufacturers to put their COVID-19 tests through the 2-stage validation process before placing them on the UK market. It would be a criminal offence for manufacturers, vendors or distributors to sell unvalidated tests.

We intend to keep the regulatory regime under review and engage continually with stakeholders to reform it as necessary in response to feedback. We believe this flexible approach will keep the regulation sufficiently agile to respond to evolution in the market while ensuring high standards are maintained continuously.

Annex A: summary of the Secretary of State’s assessment of the matters set out in section 15 of the Medicines and Medical Devices Act 2021
Below is the Secretary of State’s assessment of the matters set out in Section 15 of the MMDA set out in the government’s response to the consultation held earlier this year:

“The Secretary of State’s overarching objective in making any regulations under section 15 of the Medicines and Medical Devices Act 2021 to give effect to the policy outlined in this consultation document would be to safeguard public health.

In considering this policy and the regulations which may be needed to give effect to it, the Secretary of State has had regard to:

The safety of medical devices within the scope of this policy
The safety of the testing kits themselves is unlikely to be effective as they do not represent a health risk in and of themselves to an individual if misused. They do however present a risk to the general public health as poor information can lead to the virus spreading.

Continued...p2

The comment made in the April Prelim Results Slide Prrstation was:
'5-30m tests per month depending on access to HM Govt equipment. Additional manufacturing being sought overseas'...
Again where and how much etc etc....

Mr A...it was stated in 22 April Prelim Results presentation slides:
1. CE marking and commercial roll out commence May...(actually took much longer).
2. Good progress Distributors and OEM partners in Europe...(so far only Calibre/Bioserve. Hopefully very close to more deals to be announced).
3. Ongoing but slow dialogue with DHSC/PHE...(sigh!..again let's hope they are now making progress).
4. Working in parallel towards CE marking for consumer self test...(surely home use is now just a matter of days not weeks away).
5. Reviewing US regulatory strategy...(how far along are they with this now).

Also we have a JV in place with Daewoong Pharmaceutical and the last we heard was re financing in Feb...as this is a JV surely we can get some kind of update on this soon.
Apart from Calibre we have had no real updates since 20 April concerning our agreements with third parties even though updates were promised.

Kong1...hindsight and all that...AIM is full of 'I should haves' and 'I wish I'd have'...afraid you are the only one to blame because you bought when you did and therefore are solely responsible for when you sell.

Not sure some comprehend how many LFTs will be required going forward and the need for them to be extremely accurate. It seems to me that that UK consortium of manufacturers working with and whose productions scale up have been financed by the Govt are now ready for this new part 2 of the testing programme the Govt is about to switch to.
The Govt now has a list of approved suppliers and they can call off as needed within a defined budget and time frame. The pie is more than big enough for us when it comes to possibly getting a Govt order plus house accounts and distributor orders. Don't forget Asia and a possible distribution/manufacturing announcement in that part of the World...
30m wasn't just pulled out of the air...

'Whose test???'....various...

Bojo announcing his Covid Winter plan...Will he mention/include testing...

So is AS looking for future investor prospects or to showcase to these guys...

'Perspective from Big Pharma
Session Chair: Avi Spear, Head of Search & Evaluation, Novartis
Speakers
Anna Williamson, Director of Business Development, Roche
Nerida Scott, Head of Innovation, Johnson and Johnson
Natalia Novac, Senior Director – Venture Science, Eli Lilly
Shaun Grady, Senior Vice President - Business Development Operations, AstraZeneca
Martin Crook, Executive Director - Oncology Search and Evaluation, Bristol Myers Squibb'

If that huge buy was Jupiter then that alone takes them down to 0.31% (785K) and looking at the 5 minute volumes for the day it looks like this may have been worked through.
It would be nice to think they closed out their short today...but who knows really...

Worked buy...

2,854,688 volume today
£1m sold
£3m bought

Interesting to see what we get after hours or on the bell...

Oh and these were not factored into my £1 S & £1m B in previous...

10-Sep-21 14:27:21 136.00 1,120,000 Buy* 130.00 133.00 2m O
10-Sep-21 14:07:56 132.85 100,000 Buy* 129.00 133.00 132.85k

Looks like they're happy to hunt both high and low...today they got what they wanted by going low and putting in a double bottom at 127.50 to signal a rise back up.
We opened at 136.90 then taken down to 127.50 now back up to 131.50 and the day isn't over yet.
Also a pretty even sort of day...£1m sold and £1m bought...
Seems to me whatever they manage to get their hands on gets sold.
Monday put us 3 weeks away from Results. Now why are they waiting until the very last day this year?
These are only Interims and they should pretty much know the numbers by now anyway.
Anything materially significant has to be announced immediately so are they expecting something to be agreed/signed/incoming close to the end of September?
The next 3 weeks are going to be interesting to say the least.

TBH I don't think any of them have the answers...when you have a situation where Covid can still be contracted and passed on even after being vaccinated then the idea of it ever being stopped is a none starter.
They just want to try and reduce serious illness from it in as many as possible.