Member Info for marik

It is clearly more than a paper remedy. They will have to redo their data and resubmit with higher scrutiny amongst other things. Furthermore, they will have to explain how their data was identical to other companies who submitted for EUA. This is going to be very difficult for Innova.

It would be great to inform MP's.

PL75 it's literally a copy and paste of the homework. Innova just used another companies data for submission to the FDA. They couldn't be bothered to change the figures. This is explosive news.

Sleepydave, an interesting part of the FDA complaint is that the data the submitted for EUA "was identical to data previously provided by other manufacturers in their separate EUA requests. "

To me that suggests that Innova copied and pasted another manufacturers data. The FDA go on to say:

"The data reliability and accuracy issues noted herein raise significant concerns that the performance of the SARS-CoV-2 Antigen Rapid Qualitative Test has not been adequately established, and that the products distributed by Innova without FDA approval, clearance, or authorization could present a serious risk to the public health."

I would be surprised if Innova can remedy anything in 15 days.

Jon Deeks responds:

"Somewhat troubling news from the FDA for @DHSCgovuk. Can @MHRAgovuk comment?"

https://twitter.com/deeksj/status/1403044725255442437

Myles McNulty has made a comment on this as well and has received quite a few responses.

https://twitter.com/MylesMcNulty/status/1403048999469432833

Available directly on the FDA website:

https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication

That's put the pigeon amongst the cats.

Also note, the last RNS was on the 7th.

In addition, the fundamentals are strong. From the YPost:

"AffiDx test has superior clinical sensitivity across the range of samples and in particular at lower viral loads."

"The firm has been in talks with the Department of Health to roll out its test in the UK and it is also in active discussion with distributors in 25 EU markets."

In Al Smith's own words:

"Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX test will now play a significant part in this process."

Very exciting times ahead over the next two weeks.

It seems that there are many who are impatient, but remember, good things come to those who wait. I would prefer not to be tied up with the UK gov (reasons I've explained before). However, for those insisting on a UK order, there are things to keep in mind before panic:

- Innova has not had their contract renewed (even if they do, it won't fulfil UK Gov capacity)

- the UK Government has not announced a sovereign test (they may not have one, but all will be clear in the next two weeks)

- Avacta haven't made any gestures that they will not be getting UK sales (even if they don't they will at full capacity in Europe, US and RoW)

A.S. has made great progress to get the Affidx to market. The last few steps before announcements of sales can't be rushed because PIs are stressed. The company has a vision and is also in challenging times with the pandemic, the aim for A.S. is to fulfil the Avacta vision and also to help in the pandemic. Avacta will achieve both, but not dictated by individual investors (with less than 1% holdings).

Patience is the way forward and if the pressure is too much, then investing is not for you.

Too late for the use by date?

The current focus is on LFTs and will likely to comprise a large chunk for the revenues for at least the next two years. The question is not on demand, but more on manufacturing scale-up. It makes very little sense to worry about whether Avacta will have any sales, and it's more about how many they can produce. Being the best in market provides some future proofing for Avacta: the tests that will survive in to the tail, (living with), covid-19 will be the best in class. This is where Avacta's longevity will shine through. The other major advantage for Avacta is the use of affimers; the companies that can pivot and repurpose their manufacturing capacity will again benefit heavily. In this case, rapid repurposing using affimers for diagnosing other pathogens and detecting antigens will be in Avacta's benefit.

The revenues will run to 2022 for most diagnostics and well beyond for Avacta. The share price should therefore reflect this over the coming year and hence I'm not worried about fluctuations at this point in time. Combined with the therapeutics arm, this is a heavily derisked company with some risk, but a lot of reward. A fantastic test, ready for market and potential for rapid rise of the share price post Eurpoean and UK sales announcements.

I'm happy to hold for another 12 months, and would have the same opinion if nothing is announced for a while.

I don't think there is any time frame limit placed on the company with regards to contracts. Just to manage expectations; the sp will move dramatically on contracts, however, it will happen when it happens.

GLA

£15 is significant.

Yes I agree it's a mix.

It's definitely moving north.

There is the small issue of a potential £12Bn revenue up for grabs in the coming days. Avacta has the best in class test and home made.

S.p. holding at this level, I presume its before a strong upward surge.