Member Info for marik

This is very fishy

The bin is the best place for the innova test. How can they just submit fake data.

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https://www.ft.com/content/449c33a2-c3d5-4989-a7ae-b412e74b8781

Graeme Tunbridge, the director of devices for the Medicines and Healthcare Products Regulatory Agency, said the UK regulator, which granted Innova emergency authorisation in December last year, was “aware of the FDA communication” and carrying out checks accordingly.

“The MHRA are reviewing all available information and are working closely with NHS Test and Trace to ensure that a full risk assessment is undertaken, as is our normal process, to understand any implications for products being used in the UK,” he said.

“Patient safety is our main priority and we will issue safety information as and when necessary,” Tunbridge added. Innova’s emergency approval to distribute their test in the UK is set to expire on June 22, unless it is renewed by the MHRA.

There is no getting away from the fabrication accusations.

https://www.ft.com/content/449c33a2-c3d5-4989-a7ae-b412e74b8781

Also note; Graeme Tunbridge, director of devices at the MHRA, said in the BMJ, “The MHRA is working closely with NHS Test and Trace to ensure the tests are used in appropriate situations according to the available evidence".

Furthermore, when approached to comment, the MHRA did not deny that they had raised concerns with the health department.

Looking like this could be a very damning report on Innova. Innova claims that the FDA have got it all wrong, but the FDA has said they should be put them in the trash. The UK Government is pretending that there is nothing to see. Deepti Gurdasani from QMW also says it's not fit for purpose. C4 says that the defence of Innova will not stop.

I believe that the MHRA are not happy with Innova EUA and said that they are being used for this purpose at a "stretch". The very have provided Avacta with their UK CE mark. They are also the ones who will review Innova until 22 June. If the MHRA say it's not fit for purpose, then I don't see who the DHSC will be continuing their use. In such a situation the face saving scenario is for Innova not to comment and the UK Gov don't make comments on renewing the contract for Innova. This could be the Novacyt January 2021 equivalent moment for Innova, i.e. the UK Gov don't bother updating anyone about Innova to allow themselves and the Innova to temporarily save face.

We certainly have done well today. The MHRA will be assessing the Innova test and it's looking like they weren't happy to have awarded the EUA in the first place. My view is that they will be quite negative about Innova and I don't think that Innova will get their contract renewed.

FOMO setting in for the final minutes. Wouldn't want to be out of this over the weekend.

10 minutes for gold? Don't want to miss the Monday morning RNS.

It could move dramatically... I'm saying £5.75 shortly.

I've bought a few more and averaged up. This could well take-off over the weekend. Monday could be very interesting.

The MHRA is likely to pull the plug on Innova as they may not renew the license!

"The MHRA allegedly was concerned by the DHSC’s move in April to include Innova’s LFT as part of its mass testing programme, calling it “a stretch” of its EUA authorisation."

US warns against use of particular lateral flow test UK is buying in bulk

"Its decision raises significant pressure on the UK government over its mass use of Innova’s LFT and comes as the British Medicines and Healthcare products Regulatory Agency (MHRA) is considering whether to extend the product’s licence.Its decision raises significant pressure on the UK government over its mass use of Innova’s LFT and comes as the British Medicines and Healthcare products Regulatory Agency (MHRA) is considering whether to extend the product’s licence."

https://www.independent.co.uk/news/health/covid-us-lateral-flow-test-uk-b1864018.html

Genuine FOMO on its way. An RNS could land in the next hour - I've got a sneaky feeling that this could happen. Next week will be very interesting. Could be start of major sales information.

There will be a lot of flack for Innova over the weekend.

@LiveLongnProsper no worries. GLA

https://www.dailymail.co.uk/news/article-9676137/Americans-told-STOP-using-rapid-Covid-test-manufacturer-LIED-good-are.html

The Physicians Weekly is running the FDA's advice.

https://www.physiciansweekly.com/fda-stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test

Good call. I've been topping up over the last few days as well, it's about to go ballistic.

It's a great article.

https://www.theguardian.com/world/2021/jun/11/us-health-agency-gives-innova-lateral-flow-covid-tests-scathing-review

“It is time that this is changed to ensure that our regulator has the legal ability and independence to act in the right ways to protect the health of the public. Bad tests do harm.”

"The Guardian has contacted the DSHC and MHRA for comment."