Member Info for Trickymatters

On the Today programme. Shared the link to BBC Sounds on Twitter. Listen from 8.34am. Explaining the move away from PCR to lfts. 'One UK manufacturer currently going through MHRA approval for a self test. But we are onshoring manufacturing now to ensure security of supply'.
Could be Visitect, could be Surescreen. Looks like the contract for £374 million is prepared to land people. Close those shorts TW, Swag and all your little acolytes. No-one likes the smell of burning!

Well, not delirious. But buying another 12 thousand shares today. I think we'll have some solid progress before 25th.

Honestly don't want to get into one about Avacta. But their June results show them bigging up an evaluation which doesn't meet the sample size requirements for any regulatory authority. Whilst Avacta says the UK CTA regs mean they can't sell ODX are saying this won't make an impact on their new distribution agreement.
The main point I would like to emphasise is that this is a bit of a setback for the whole industry. Only 2 self tests are on the list of exemptions and 0 on the approved list to date. If we were to get any of our approvals in tomorrow for example, we are very likely to be prioritised for either derogation by selection for public health and/or UKCTA. We could end up with a sudden advantage in this industry over some very big players.
Anyway, food for thought. I see Twatcher is picking on the little littluns today. Nice.

Fair enough Regulator. Only read the bloody thing yesterday and I've got the detail wrong! Lol. I stand corrected.

It won't be too long now before ODX gets the CE Mark from it's ENB. We are much further ahead than other UK testing companies on this and we now have a situation where there's only 3 testing companies on an approved UKCTA list and none of them have an approved lft self test for commercial sales. The travel industry are going to start kicking off big time. More broken promises from this government. They will have to sort it out if they do want to save the airlines.
In the meantime the UK CBTA regulations do not apply to the DHSC test- special derogation para 34a of the amended legislation. So Surescreen are OK. And whoever they choose for us to manufacture will be ready to go. So £374 million contract is on the table.
If the objective is to help the airlines as they have told us repeatedly then as soon as that CE Mark lands we are going to the front of the queue. They want to thin the market to get dodgy firms out but they don't want to end up with only 2 companies with self tests. We would have to have waited a few days for MHRA to confirm marketing authorisation anyway. It's only a desk top review not a laboratory reassessment. I am confident ODX will be first out of the blocks for a UK self test.

Looks like a standard letter with out of date information. The PD process has been replaced which was trailled some time ago with a consultation with the diagnostics industry. As we know there were widely perceived problems with the lab based assessment. The amended legislation has been patiently explained today more than once by Regulator.
If Margaret Throup MP wrote that she could be a bot in her spare time because there's a lot of spelling mistakes in there.

Hard to know which list BIVDA are talking about. If it's the travel list, ODX is on it via Dam. In which case, no wonder Dam are so excited about the ODX distribution agreement.
Avacta haven't got an EU notified body CE Mark or any kind of approval. Looks like they are just jumping on this attempt by the UK authorities to ensure testing standards after recent PCR scandals, to cover for the fact that they were slow to get a large scale evaluation done as required, spent time on a saliva test when nasal swabs are required and therefore massively behind everyone on getting applications done. NCYT have also had their own troubles with the UK government. More uncertainty is not what we need. But it looks to me that ODX will be unscathed from this situation. They are in regular contact with the DHSC team because of their contract award. They will be ready to go when the EU notified body award the CE Mark imo. These regulations are not new. They have been in place since August. CK will have anticipated necessary applications. Avacta are not ODX.

TCO, read the NCYT RNS.

Interesting that we are getting hit because Avacta haven't been approved. NCYT have only had 1 test put on the approved list. Nine products not listed. In the meantime Dam are saying Visitect are approved for professional use and are quoting results that easily exceed test requirements. Another g8 British **** up? Or 2 competitors making excuses for not making the grade? If the former, it will sort itself out soon enough. The pressure from the airline industry will be big. If the latter then ODX are winning the race for a British lft to gain approval for self tests.

Looks like one of the ODX staff team wants in as a shareholder. Wonder what they know? Lol. Self test approval is in the bag imo. Dam are heralding ODX as best in class and got themselves on the government travel list, advertising lft self tests as coming soon. Extensive EU and UK presence as a distributor. Tick tock guys and gals!

Lovely. We're on our way! Well done for holding on in there, all lths. Good to see the results of the FIND for Visitect. 96.7% sensitivity and 100% specificity. Easily exceeding all regulatory authorities thresholds that I have seen. The EU, FDA and UK require an excess of 90% and 98%. Puts us in the best in class category.
Should be a great month.

Lol. MHRA just issued advice on the travel list. To say 'they are aware' that not all providers on the list are authorised. They urge the public to check for a CE Mark and report it to the Yellow card site.
Joined up government anyone? I had a feeling that was a **** up! Let's hope they have pulled their socks up by Monday. Anyway, looking OK for us I think. All to play for. Retail sales at least £20.00 and we are way above the new thresholds. CE Mark just needs to land ASAP.

Well read the paper I've shared. It's an amended version of the CV19 Test Device Approvals Regulations 2021. Amendments are following to a consultation process that's been running for a few months. Obviously there's a process for approval but ODX vastly exceeds the requirements. It's a slimmed down process- (which we knew- the DHSC introduced a desk based review to replace PD some time ago) and a much lower threshold for accuracy (which we did not know).

Hedgefun. You are now my filter list. I'm sharing facts as they emerge. Relevant to our investment. You are not an investor. Troll tactics won't ever change. These constant circular arguments are meant to confuse.
The travel list has clearly had a few hiccups.
However, the fact is we are very well positioned to get on this list. Requirements are nowhere near as strict as the MHRA standards. I'm surprised to see this and I bet I'm not alone in feeling that this position will soon become subject to political pressure. But either way ODX could easily get on this list now if they want to.

So Visitect and Mologic are 30.9-36% above the minimum sensitivity requirement depending on ct values. And 7% above the minimum specificity requirements.

Performance requirements for coronovirus test devices. Recent amendments.
https://www.legislation.gov.uk/uksi/2021/910/made
See 38B. 3) A coronovirus test device that is an antigen test must have-
a) a level of sensitivity using 95% ..confidence interval that is entirely above 60%
b) a level of specificity using 95% ..confidence interval that is entirely above 93%
Registration is via the uk.gov
Cost is £14k or £6.5k for an SME.

OK. Will share the criteria such as it is for providers to self declare. Give me a mo to get on my PC.

Is still down. Bit surprised to see that they aren't endorsing the tests on it and telling travellers to 'do their own research'. Only 21 providers so far. Price range from £19-35.00. The cheapest has been sold out all day. Otherwise anything under £29 isn't available at the price advertised on the government site. Sometimes not available at all when you go to book- ie. the lateral flow tests are not listed on the site.
Another government **** up then.
Not a whisper of Innova et al on the list.
We need to keep a close eye on this. It's a live list and they will add to it as new tests become available. Obviously not ready to meet their own deadlines. Classic. Looks like we don't need any authorisation to get on it. Probably not a situation that will be tolerated for long though. Will share the UK.gov advice in a bit if anyone wants to see it. Hoping it's a mistake actually. But if not, ODX just needs to get a test on for less than £28 and we are dominating this market.

Think you're a bit insecure McManus. You keep banging on about my MBA like a right nutter.
The EU database on approvals was updated yesterday. I have been in ODX far longer than GDR. Blocking you now ****fest.

https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/925
Oops. Sorry. They have 3 tests listed. That's the POC, 21st August update. This is from the Genedrive kit is also listed from May. The data as a whole (for all tests is reviewed every 6 weeks) so I thought this was new. Still I haven't seen it shared here. Maybe because I just look away from this board nowadays. Lol. I think it's looking a bit better for sure anyway. You all make your mind up. A POC launch is due and 100% sensitivity and specificity is looking like it can't be better than that. I'm interested in actual research and information rather than the constant trolling that's on offer apart from some valiant efforts from a few brave souls. GLA.