Member Info for beinthelead

Yes. Seems logical and open as they reference it as ‘the test and trace LFT’.

Timster - is it correct that any test procured by HMG is given home use exemption?

https://www.gov.uk/government/news/mhra-issues-exceptional-use-authorisation-for-nhs-test-and-trace-covid-19-self-test-device

Lots of decent folks still left here, but most have disappeared because of this bunch. Got to say, it is tiring. Time to logout and add value when I happen across any.

The subtle derampers are worse. At least the ‘out and outs’ are honest with their intentions.

Don’t be a busy fool. Patience does pay, and often outweighs chasing gains.

That’s my strategy anyway.

PL - exactly.

Scaredy - I posted this yesterday.

“...beginning Jan. 1, 2021, after the transition to the UK’s exit from the EU formally ends, any medical device, in vitro diagnostic or custom-made device “will need to be registered with the MHRA before being placed on the Great Britain market,” MHRA said.

The CE mark lets us sell across europe. We need MHRA approval to place the product on the UK market, alongside CE. Two separate things.

Why would we need MHRA approval if we weren’t confident of UK sales? And to get UK sales you need manufacturing capacity. Who’s monopolised this capacity? HMG.

They are, as stated by AS in the investor presentation.

Not worth getting frustrated Mr A. We’re here now :)

Roly - if we don’t secure orders for our forecasted 5m/month, we’ll drop a bit. As in, the SP is underpinned (and then some) by 5m/month. Please understand this.

If it is ‘us’, I assume you mean supply to HMG? Their predicted demand is 60m/month.

In summary -

We sell nothing: we fall back a bit
Sell the bare minimum: SP £3.10
It is ‘us’: SP £10+

Mitigation; we have the best test in the world. Contracted capacity. Customers aligned. Orders coming this month.

Basic, basic stuff.

Me too. Very bullish. Across the range, and most specifically, the infectious range. Better in both.

“...beginning Jan. 1, 2021, after the transition to the UK’s exit from the EU formally ends, any medical device, in vitro diagnostic or custom-made device “will need to be registered with the MHRA before being placed on the Great Britain market,” MHRA said.

Looks like we’re using some of that UK manufacturing capacity.

We’re nothing like SONA, and the n/s debate has happened forever. We’re S, the other are N. Non of the others have been chosen to date. Simple as that.

We’re the best performing test.

Decided through conversations with the government.

Yes, agree they are being more flexible and realistic. Hence the equivalence test requirement.

Same standards and equivalence tests. Standards and specs are constraints. The location, i.e. PD does not read as a constraint.

How scardey?

Exactly Radia. Most telling piece in the contract for me, word for word.

We’re a different animal Shan. No comparison. The SP will fly to where it chooses, based on sales and sentiment post May. Then we’ll have the other businesses powering through the noise.

Really is no comparison.

SureScreen are still supplying HMG.