Member Info for scardey_cat

From: ***************************
Sent: 10 June 2021 21:04
To: 'soniaelijah@protonmail.com'
Subject: The Innova tests: another Covid scandal in the making? Part 2

Dear Sonia

I very much enjoyed reading the first two parts of your piece reporting on the Innova tests.

I must say, it was very refreshing to read such a well researched article, since I have for some time found it quite strange that our Government have put so many eggs in the 'Innova basket' and yet, to date, no serious journalist has called them to account for their very questionable claims about the accuracy of the test and the 'use cases' they have been deployed for.

I am aware that you are due to publish Part 3 of your expose, but before you do I would like to make you aware of an important decision made today by the FDA. Please see link below for details.

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/removal-lists-tests-should-no-longer-be-used-andor-distributed-covid-19-faqs-testing-sars-cov-2

Basically, for a variety of reasons/violations the FDA have banned the use of the Innova test and Innova have issued a Class I recall (the most serious type of recall) of the tests.

I hope you might find this information useful when putting the finishing touches to the final part of your report.

Kind regards

Sleepless night ahead for Sonia Elijah, busily editing Part 3 as we speak.

Part 2:
https://www.conservativewoman.co.uk/the-innova-tests-another-covid-scandal-in-the-making-part-2/

Proper chuckling at that Will :-)
By the way, Avacta went closing only on IG this morning, so no avenue to get back in there.

[SC, for the billions involved, they'll be doing the "all but impossible to turn this around".]

Reading the long list of violations, suggests Innova would almost have to go back to square one with their test, with evaluations, clinical validations etc. etc. We all know how long that takes. Mission impossible I'd say.

@TPNY. This is potentially great news for Avacta re: UK market. The US market can come later, though we may not need it now.

"The FDA gives them 15 days to "correct the noted Quality Systems and MDR reporting violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again"

That's just a standard paragraph they would include with any violation, regardless of how serious. If you look through the FDA complaints, you can see it will be all but impossible for Innova to turn this around.

That conservative lady doing the Innova expose needs copying in on this.

Halle fukcing lujah!

Wouldn't take too much notice of Bighero (formally S.A.Tan on ODX - "soon to be a very rich man").

In a couple of weeks, he's gone from running a Chinese takeaway in Alva (where he used to glean information from Omega employees, whilst waiting for their orders - because they felt safe thinking he was Chinese), to now running an Indian takeaway in Devon.

You can guess what he said when he left the Chinese, yes, you got it, "So upset I'm off"

Bighero
Posted in: ODX
Even Bighero is struggling today with this share. Should have waited for a few more pence to drop before buying my 43000 shares. I will still sell in the 70s though. For now I will be concentrating on running my delicious Indian takeaway in Devon.

"As soon as the Avacta website was updated I emailed them for purchase details for my company. No reply even after a follow up."

I think biffa makes a good point. I mentioned a couple of weeks ago, a friend of mine with an events business in Southern Spain made a similar enquiry and received no reply.

All pointing to Avacta having bigger fish to fry.

Have you tried the Whaler?

Do you really think moaning and crying and bleating is going to help?
Just sell your bloody shares if things are getting a bit hot in the kitchen for you.

As Gary Barlow would say 'Have a little patience'. The test has only just become commercially available. Limited UK market currently, for obvious reasons. As I said earlier, acknowledgment from EU certified body (due imminently) opens up a huge professional use market and I don't just mean Europe.

@PJT
If you have any doubts about Avacta's sales team, I suggest you have a quick read of David Wilson's CV on LinkedIn
https://www.linkedin.com/in/davidswilson/
Looks very impressive to me.

We've ended up with a 'govt beating' diagnostics industry, when you look at how Abingdon and Omega have been treated.

Also worth pointing out to her, that the S&S figures she's quoting are for NP method of sampling (for which the test was designed). In reality, the test is now being used as an AN test, so resultant S&S figures will be much lower. Whereas, Avacta test designed for AN method from the start - with much superior S&S.

"Bidstats total for 'Innova' orders is £4,011,000,000 so more like £4 per test."

And now they're cutting the aid budget by £4bil. Great work Boris et al.

"So a stockpile of a billion tests!"

@AgentB. That's not a stockpile, that's the total number purchased since Innova arrived on the scene.
They've been using them up @25mil per week for months.

7,500 UK cases today. That's up from about 2,000 cases per day from 2 weeks ago. Did somebody mention the word 'exponential' earlier?

I noticed that too @hants. At £5 per test, that £1.2bn represents about 240mil tests. So, 10 weeks worth, if using 25mil per week. The last top-up order for Innova was a couple of months back, so can't have a massive stockpile left.