Member Info for Toukankahmoon

I hope you haven’t sold me a dummy here, I’ve taken your FOI at face value. I previously posted on here the response my MP received for me from Maggie Throupe minister for vaccinations etc. For a reason that was not clear to me my post on here was met with abuse.

Anyhow, when I saw your FOI response, I decided to reply to my MP. She in turn has seen fit to reply to Maggie and copied me in.
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Dear Maggie,

You previously responded to an enquiry from my constituent, Mr Derek Shute, regarding approval of lateral flow tests. I am writing to you again to ask about some matters that arise from these enquiries.

You will see below that Mr Shute has been informed that there are five full time equivalent scientific advisors reviewing applications for approval under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA).

Do you believe that this is an appropriate level of resourcing of what seems to me to be a very important task, given the situation we face?

Further, no companies applying have been approved yet. What do you believe the cause of this is? What is the process for improvement to make it more likely tests will be approved in the future?

I would be grateful if you could respond to these further questions.

Thanks and best wishes,

Alison
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No editing this time - reply in full

I won’t hold my breath for a response.

Boris is a survivor.

Don’t know CAGs reputation, but this is great news.

Knotagain
Thanks for your constructive post. So what were the vital good bits I left out?

Knotagain
I’ve checked and I cannot see that you posted the Maggie Throup letter on this BB.

Also I am at a loss for the “imbecile” comment. Do you believe this Govt drivel. I hope that you did as I have just done and sent a reply exposing the misleading info the letter contains. Probably won’t do any good but made me feel a little better. I’m seething.
Oh and finally, what did I miss out that has annoyed you?
Make your reply constructive rather than abusive please.

I’ve just received, via my PM, a reply from From Maggie Throup MP Parliamentary Under Secretary of State for Vaccines and Public Health

I will cut and paste some of it:

We are committed to boosting UK manufacturing and demonstrated this with the award of a contract for 20 million devices to Derby-based test manufacturer SureScreen Diagnostics. These lateral flow device (LFD) tests were the first British tests to be validated in the laboratory by Public Health England and the first UK-manufactured LFD tests to be approved for supervised testing. These LFDs are able to generate a result in under 15 minutes.

Our Dynamic Purchasing System, a procurement tool that allows qualifying suppliers to compete for contracts, will diversify the supply of LFD tests through fair and transparent competition. Further information can be found at www.gov.uk by searching for ‘national technical validation process for manufacturers of SARS-CoV-2 (CO. .

To be purchased by the department, LFD tests need to have been validated by Porton Down and must have regulatory approval in the form of either an exceptional use authorisation (EUA) or a European conformity (CE) mark. None of the products for self- testing with Medicines and Healthcare products Regulatory Agency EUA approval or a CE mark are currently manufactured in the UK.
The joint Porton Down and University of Oxford team has developed a rigorous validation approach, which can be found at www.gov.uk by searching for ‘protocol for evaluation of rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices)’. The current validation process consists of three assessment phases of increasing stringency. Phase 3a is a validation against clinical samples, and successful completion of this final stage means a product has demonstrated suitable performance and is therefore eligible for procurement .

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I think you can guess my response

GLA

Anbingdon directors must be spitting feathers over Avacta letting them invest heavily on the basis of successful TT when they knew they were gonna pull the plug on Affidx.

Let’s hope that there is still enough trust for them to invest in TT and manufacture for Avacta.
GLA

Not sure mkt will believe Al so prob have to wait for clinical trial results.

How long it takes is an issue because there is clearly no point in producing an LFT for a variant that is no longer a major threat. If the tweaking cycle is longer than the variant cycle then there is no profit in it.
Just saying.

Marik
Ok so what are the stages and therefore the timeline and will Omicron be old news by then?

Ok. I get the jibe. But I’ll tell you anyway. It’s the name I’ve used on investment BBs for past 30 years.

But back to the topic in hand can someone who knows what they are talking about just list the stages Avacta have to go through before they can put Affidx back on the market. Then put a timescale on each one. Add them together and add another month for sales revenue to flow through and see what date we get.
The answer won’t be tomorrow or this week.
GLA

Looks like peeps are coming round to the timescale I guessed at a couple of weeks ago. Basically after new product produced and TT completed to produce a batch for clinical trials and product authorised fo UK use, we’ll be very lucky to get a couple of weeks sales revenue at end of March. By which time the next variant will be rampant.
Forget about LFDs our money will come from AVA6000 et al.
GLA

Hi Vegas
Just dropped in to see if there are any useful links to latest on Avacta. Sadly no. Only the usual abusive potty mouthed stuff from the rampers.
I think therapeutics future for Avacta is amazing
Don’t think we’ll see any dividend from Affidx sales - even Rippers said that the other day.

GLA

Thanks. You’ve cheered me up after a sh*tty week.

Ripley
I have to laugh
Before Xmas when I posted “don’t expect LFTs to generate any dividend, I got a whole load of abuse.

Just saying.

Ndn
Thank you

Yep.
The therapeutics will be life changing for cancer patients and hopefully our investment will be rewarded as well.
GLA

It does my head in that we have to slice and dice and analyse these RNSs to tease out the best possible outcome. If Avacta had meant this and that then surely they would have stated it clearly. After all it’s in their best interests to be totally clear about what lies ahead. Or is it?

For nearly 2 years I’ve been reading posts on here about what an RNS meant and trying to put a positive spin on it. In most cases the RNSs have meant what they actually said or worse. No NDAs, no secret deals just a hard slog through bureaucracy and sh*t.
I remain a long term holder.
GLA

Are they sending out cheques to further delay money leaving their account?
If your money has earned interest then that is illegal unless, I guess, it was very clearly stated at the outset.

*and ndn *

Thank you Blackcat abs ndn

Fingers crossed then