Member Info for TWatcher

"keep the faith"

ODX isn't a religion

In fact surescreen has clearly passed 3B validation, as that is a mandatory product requirement of the contract see page 51 of the surescreen contract here:-
https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000kGWF/r6IZcQe9syh4ZG0xns783ALda6NOsCOYeodrO0HjEcE

That quote was from the BMJ, which he referred to on several occasions and he was basically making the case that LFTs are useless.

He also said that the contracts that were supposed to go to manufacturers have now been given to the other chinese provider of LFT ?

No idea why you'd think I'd enjoy the price falling, I've never expressed a hope for it, or a target price or ever advised people to sell (or indeed buy).

What i've said (for literally most of 2020), is that there are no orders, there are no sales announcements, not a single one, and that a lot of rose coloured hyerbole has not been based in fact i.e. that the FDA issue was going to be fatal for Innova, or that ODX was manufacturing month after month at full capacity (at this time ODX would have around 30M units in STOCK !), or that the workforce meant that obviously there was an NDA in play. NDA is always the one that people go to when they want to excuse something using a device that by definition can not confirmed or denied.

I was in fact the first person on here to suggest that the ever extended timeline made it looking increasingly likely that MHRA had failed to validate the Mologic test, and this has proved to be the case. I also said that if such evenutality, you are looking at many months for another test to be TTed.

And for those that say £50M to £374M is a cast iron contract from the gov, I'm the first to highlight that the contract allows uk gov to exit if the test is not validated by the 1st of April, and also the gov to exit WITHOUT GIVING ANY REASON, by simply paying a 'termination charge' an amount no greater than 50% of the first quarters charges. See page15 section13.3.1 which confirms the option to terminate "by convenience", and page 65 section 6 that details the termination charge of this document
https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000kI0H/EySZ28HhbGWp.KyQFExkrBzY54f6HXd6hOd1W5fDn3E

Thus far, everything I have pointed to has been validated. However i have held out including now, on the belief that ODX would get a sizeable order from UK gov. But with Mologic failing validation, and with indepth reading of the contract, and with a covid landscape that is entirely different than it was in Feb, that contract is looking less secure.

Nice to be missed.

Ella10, this is Porton down you are talking about, probably some of the top scientists in the country, they work on biological and chemical weapons, they'll know how to drop a few bits of liquid onto an LFT and see/not see a line !

so its something else.

"the last thing we should be worrying about is the government cancelling the contract."

now where have I heard that before ?

FDA failed to authorised it, MHRA did, MHRA does not always follow FDA. Your stated "trust me" 25 years experience of everyone following the FDA is factually and demonstrably wrong, get over it

"Can we have some demos please?"

To be fair the implication of the Mologic response is pretty much as per the above, they are stating that they can't figure out any way that PD is getting the failures that they are saying, and want independent witnesses to watch PD repeat the process.

Unfortunately, once you get to this stage and in particular litigation, I think we need to forget any thoughts of the mologic test being a sov test. PD aren't going to back down, uk gov can't do anything else but to support (and its not impossible that they are 'encouraging' these failures for their own reasons), and once in court its you might as well say goodbye to 6 months. And should by some magic Mologic win, its hardly conducive to a long and healthy relationship, with uk gov likely to do the bare minimum to see out the contract.

Never underestimate the ability of politics to achieve the desired outcome.

"Looking after there own I'd say. Plentiful supply from J&J / Pfizer. We could take a leaf instead of depending on chinese shzz!"

Nice attempt at dodging the facts which is that the FDA does not lead the way in all things (e.g. the AZ vaccine) contrary to your "experienced" determination.

"I have 25yrs working in pharma and medical device industries and trust me when I say If you think other regulators inc. MHRA ignore FDA advice you are completely wrong. FDA lead the way."

FDA has refused to authorise the use of the AZ vaccine. MHRA has authorised it over 6 months ago in the UK and 10Ms doses have been administered.

What's your 25 years of experience say about that ?

given nothing has been announced for 9 months, any order would be significant now.

MHRA isn't mologic's problem.
Porton Down getting 30% kit failures was the problem.

So just to be clear, innova EUA being cancelled would have been a wonderful thing.
Innova EUA being extended is encouraging.

got it.

dsaf: "I hope they use it and we can start selling and be free of the chains of the DHSC."

I remember many saying that about the RTC antibody test, with some heralding the end of the contract as the "great unshackling day". That date was over 4 months ago...no orders.

And of course ODX has been in a position to market and sell the visitect antigen test for months...no orders.

"if that's correct it's been there all the time so why point it out now didn't you see it before"

Have you not seen the recent related news ?

A few days ago government made a point that they had get out clauses in the contract
A few days ago Mologic confirmed that Porton down have failed there test due to high kit failures. We did not know this previously.

Both those are new information, and in particular knowing that PD has failed to validate the test is pertinent when you consider not being validated by 1st of April is a get out clause in the contract.

And anyone who has been around this share for a while know that Gov has used a gov department non-validation to get out of a contract previously.

"Fool me once, shame on you, Fool me twice, shame on me".

It was interesting to note that in response to the questions that were answered regarding the Surscreen contract, the answer was at pains to point out that they had get out clauses in the contract.

I took a look at the ODX contract.
page 1 paragraph 3.1.2 ("the supplier must") Obtain the Product Anthorisation by the Long Stop Date.
page4 paragragh 3.6.
"The supplier shall by the Long Stop Date ensure that agreed quantities of pre-production samples and testing samples of the goods have been tested in accorandance with the testing procedures and test success criteria agreed with the authority......and have been confirmed as meeting the same standards and equivalence as the test which had previously been performed on the good by PHE at Porton down.

The long date in the contract is 1st of April. (There is a term that allows the long stop date to be adjusted if it is agreed by both parties)

If gov had indeed picked the Mologic test as a sov test, and told them to get cracking, then it not being passed by porton down by 1st of April is a get out clause for the government. If so this £50M-£374M contract could be pronounced dead. Unless the long stop date has been extended.

Page 15 section 13.3.1 is particularly interesting, it allows the authority to cancel the contract at any time, without ANY reason. If they do so then a termination payment is made. Schedule 3 outlines the termination payment and states (page 66 section 6.4) amongst other things that the upper limit of it is 50% of the first quarters charges.

Remember that uk goc have a history in this regard. The contract for RTC antibody had a clause that required MHRA home approval by 25th Dec, otherwise the contract would be cancelled. The gov indeed did not honour the contract beyond the original order of which ODX got 250K units.

MHRA and Porton Down are both government bodies.

"I think some smart money is flowing into ODX."

Evidenced by the share price falling...that must be REALLY smart money :)

The gov was never going to do anything regarding innova. All those 100s of messages saying the US decision had any implication on the usage in the UK where either uninformed gods*its or deliberately once again trying to ramp up the share price for an exit.

So can those that were spouting this nonsense, and heralding the 21st of june as yet another d day for ODX, come back and tell us how wrong they were and apologise for spreading unfound rumours that had zero basis in fact.

So whats the next date for ODX d-day...we aren't waiting on MHRA (so no "any day now"), We aren't waiting for TT for the antigen test(anlready happened), we aren't waiting on Porton down to validate the test (its already failed).

We are back to waiting on a gov that will entirely in its own time decided when and if a single test rolls of the sizeable portion of the ODX capacity that the gov have complete control over.

oh...and waiting on orders, which we've been waiting on for 9 months.

Nothing else is pending.

"They had circa £5.5m in the bank before we knew about the HMG cash payment - nothing to see here"

That is factually incorrect.

The facts are they had £6.9M in cash at the end of the 1st half (30th of Sept), announced on the 30th of November.
In a trading update of the 11th of Feb, they PREDICTED £5.5M-£6M for the year ending 31st of March.

At no time has ODX RNS'ed they have £5.5M in the bank.

They've had no notifiable sales, no announced orders, they've taken on a s*itload of staff, and apparently the warehouse is bulging with stockpiled products that will have cost plenty to make.

Gov cassette and pouching started after the year end(31st of March), and ODX has confirmed that £2M of the £2.4M from the gov was also paid after year end.

It someone can't read, digest and understand the official information from ODX, what chance of having even a basic understanding of the business.