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Thanks @Scardey. With Parliament breaking for their Summer Recess on 22 July and the new regulatory framework needing to be in place by 1 September, they'll have to get a move on to get it through before parliamentarians dig out their buckets and spades. It hasn't been published yet, but I'll try and look out for it.
Scardey, good luck with the reading over the weekend, as there is a lot to go through about the *private* COVID-19 tests and the traffic light systems.
I'm also gearing up for an England win this evening and quite a lot of reading.
GLA have a great weekend.
@Tzarr68
I have about 4 different govt web pages open in Chrome. Haven't had time to read them all, will catch up at weekend.
However, this is the page that summarises the current situation regarding 'draft' legislation:
"Government sets out laws to validate accuracy of private COVID-19 tests
New draft legislation will make it easier for consumers to buy good quality COVID-19 tests with confidence"
https://www.gov.uk/government/news/government-sets-out-laws-to-validate-accuracy-of-private-covid-19-tests
The don’t need an extension, the new legislation will come in to force and they’ll be exempt. But I’ve already said that, so I’ll leave it there…
I'm not the one asking for explanations and have no need to get back to anyone. However, let me fix my previous statement:
There's no point in forcing a square peg in a pin hole. They don't have exemption beyond the 2 months.
The market has reacted to account for the recent changes, its positive news.
Hope you enjoy the football tonight and the weekend. Alistair will explain the positive nature of the news next week. I've topped up.
GLA
@Scardey, is it new MHRA guidance (the link below) or is there some other legislation? Thanks
Learn the difference between extension and exemption and get back to me.
There's no point in forcing a square peg in a pin hole. They don't have extension.
I'm out watching England v Scotland tonight AgentB, so it won't be happening on Saturday morning, that's for sure :-)
Also Marik,
Would you put it past this Gov to extend the extension?
@Scardey, glad you are taking that one on!
@marik
If the new legislation is passed, they do have it in black and white:
"Tests currently supplied to the NHS under DHSC procurement will be exempted in recognition of prior equivalent assessment."
That's why I think a campaign targeted at our MP's should focus on tabling an amendment to the Bill, to remove this exemption status from the new legislation (on the basis of it creating a non level playing field). The work AgentB has already put in, would form an excellent basis for such a request. That way, not only do we inform our MP's about this outrageous situation, we also give them a route to do something about it. This is my homework for the weekend.
Innova have extension for 2 months and that's it. There is nothing further, not in colour or black and white.
@marik
What do you mean, there's zero chance of exemption, they already have it in black and white.
There is ZERO chance for exemption. They've been given a two month extension and that's it.
There’s every chance Innova will be given exemption, there is massive fraud going on here, hopefully it comes out and shows this government to people what they truly are.
There is ZERO chance of Innova gaining back door exemption.
I'll be adding shortly, assuming there is no RNS at 7am.
Well done long term holders. The penny is about to drop.
GLA
No, they’ll be exempt via the new legislation so they can keep the brown envelopes flowing
So they change the criteria again so no current test on the market can achieve it, and on same day say the DHSC procured innova test is exempt from these changes. Will a new test appear in next 2 months that fulfills the criteria, get ce marking, pass PD etc? Of course not, so then govt will give a 12 month extension come September. Also explains why innova were happy to move production to wales, regardless of FDA scandal they would have been told weeks or months ago about these changes and that they'd be safe to go ahead.
I hope avacta have given up on the UK market now, just go for Europe and B2B sales. I'm trusting As is wise to what is going on, tell the Govt to ram their NDA. Absolute joke.
With this Government, I wouldn't have put it past them to have multisampling of stool + saliva as the optimal choice.
I'll give em a stool sample. Downing street dirty protest is in order.
LOL. They've moved a few things, but I think the key point is the Innova will not measure up whatever the movement. That explains the 2 months extension for them and they will be dropped there after. For me this is a very positive move. The LoD, PPV and 1-NPV work out well for Avacta at low prevalence. Excellent news for Avacta.
To top it off Jon Deeks deems this "well thought through and justified (there's lots of maths at the back) to explicitly stating the evidence and performance levels we need."
The game is afoot!
What's the chances that they just go, "Who is the cheapest?"
I can’t see desired being met in full by any test, if you try and tick every box you’re basically using magic
WTF
Sample type
Desired
Method not requiring a swab (e.g. saliva, sputum, stool, breath sample)
Acceptable
Nasal and/or throat swab
Hey, why not move the goalposts again?!?