Member Info for RegulatorUK

"https://www.lucirahealth.com/

Rapid home test kits authorised by FDA."

Never forget to read the small print:

"This home test kit has not been FDA cleared or approved. This home test kit has been authorized by FDA under EUA. This home test kit has been authorized only for the testing of nasal swabs for detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This home test kit is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner."

This has not been approved by the FDA. It has a limited EUA.

"On what sensible basis is anyone buying or topping up."

I'm topping up on the basis that:

(a) this is my field of expertise (healthcare);
(b) I understand how the development and production of medical devices works (I can almost quote the Regulations by heart);
(c) I understand how quoted companies work and what their obligations are (I'm a PDMR) - something that appears to be lacking for many here; and,
(d) I understand that RMS is more than just a mask.

I also know it's not wise to make potentially defamatory remarks on a public forum...

Lots of potentially defamatory posts this morning from moronic posters who clearly have little or clue about:

(a) how the stock market - and AIM in particular - works;
(b) how this sort of manufacturing works;
(b) how PLCs works; and/or
(c) how health related products are developed, produced and marketed.

Hopefully once the moderators have taken a look they'll weed out the worst of the trolls and muppets, and the board can get back to some semblance of rational, adult discussion.

There is no machine currently installed at Biocity. That much is clear from the various RNS, for those grown ups who are capable of comprehending plain English.

There is no need to misrepresent the position or ramp this stock. Its time will come... the need for masks is not going away.

"But the Volz deal hasn’t been signed off yet has it"

Correct. Last information that was provided was "Over the weekend P2F signed binding heads of terms with a manufacturer of surgical masks in Germany.... The heads of terms are subject to final contractual agreement between the parties."

There has been no confirmation to date that the final contractual arrangements have been agreed, which I why I do not believe that Volz will be producing at scale at this time.

"I’ve dialled both enquiry lines on the RNS and the guys on the other end have assured me that this is the best thing since sliced bread. They even went as far as to say that if they held shares there’s no way they’d be selling at this point - no idea what they mean by that but it must be really good."

Hey folks.... we have a nomination for the Didn't Happen of the Year Awards.

"Anyone with twitter can you tweet pharm2farm to clear up whether this is re an additional machine as many are saying or the first machine? I remember reading a message in advfn when we were last in the 1p range where someone had posted an email reply from the dr where he said that he was on his way to check over the machine before it’s commissioned ? Anyone got access to advfn old messages can post this ?"

As far as I am aware, the production line referred to in this morning's RNS is the first/only production line that P2F will have at its Biocity premises. This interpretation would be consistent with the RNS issued on 16/11/2020, 11/11/2020, 23/10/2020 and 18/09/2020 (the latter two being BRH RNS).

There is nothing to suggest that masks are currently being produced at scale by P2F or by a third party on their behalf, although an agreement has been signed to allow it. If other believe that masks are being produced at scale, then I would challenge to provide substantive proof - not assertions, but links to substantive evidence.

The reality is that these sort of delays are to be expected with these sort of new product developments. Production timetables for new machinery will be hit by Covid and this will have a knock-on effect for inspection, installation and commissioning, etc.

But it's a delay - not the end of the world. We have a world class product and demand for it is not going away. Don't focus on the short-term 10% gain in the SP but on the longer term value that this stock will bring.

And if people are daft enough to sell up on this news, I'll happily hoover up their holdings...

I'm not surprised that the PHE framework is late... I'm working on another DHSC sponsored framework at the moment and that's running late as well. Frankly, the people they have doing their tenders couldn't organise the proverbial is a brewery - despite this being a straightforward and simple process.

Trot on troll boy.... Mummy's calling you for breakfast.

"What you have to ask yourself if it was so good why is the stock value dropping."

You have to ask yourself what sort of person, who isn't invested in a stock, hangs round a BB asking stupid questions.

“ I'm reading all these beautiful stories in my humble opinion this share will not reach more than 65p ,‘

Nobody gives a **** what some sad troll thinks...

"Regulator. Out of interest. How do you interpret the order worth £75m. Is it not a framework. So one they will call off tests from. So 20, 30 maybe 40 m tests .. depending on actual cost"

Yes - it's a framework contract. What we don't know is the unit price being charged (and Colin did say that would be the case - just it's better than they had initially expected) so we can't actually tell how many tests that £75 million potentially represents.

"If could be that framework commits them to a 10M order, unless MHRA approval doesn't happen, and they decide to execute that clause.

Or it could be that the framework does not commit to 10M order, but should any orders be placed and not fulfilled at a time when MHRA approval in refused, then they have the option to cancel those orders."

I would suggest the latter. My reading of what has been published to date is that these are 'call off' framework agreements - they don't create an order as such but rather put in place the ability to place future orders (up to a particular level or threshold). There are a number of presumptive and preemptive clauses which give the DHSC some leeway if particular conditions are not met.

"derogation is a word in my vocab, its something I had to look up.

It means to take away. That would suggest that the initial "approval" of the processes gives it home use/ self use and then when the user experience studies are completed, they might take away the approval. So if the above is right, technically they have approval for home use in the first instance ?

Can someone validate/correct my interpretation ?"

It's slightly different in this context.

In law a 'derogation' is the partial suppression of a legal requirement (not to be confused - as it sometimes the case - with abrogation or obrogation).

So a derogation means that part or all of a legal requirement is being waived in a particular context - an exemption is being applied. How long any derogation lasts for will vary. A derogation can be temporary or permanent.

"At least i wont lose any content since your posts contain as much as a fart in a light summers breeze"

*Snork*

"1) The case is against the govnt, not the RTC"

Just to be pedantic, in the application for JR the Government is the Defendant but it is also against Abingdon Health as an Interested Party.

As you say, I don't think it has legs.

"Regulator - humour isn’t your thing. Why don’t you stick to being the boards Mr Clever Richard."

It wasn't an attempt at humour...

"How do you block someone on here??"

Unfortunately, you can't block yourself. Just ask the administrators to delete your account...

"Has anyone heard of Good Law project has initiated legal action against UK Gov for involvement with UK RTC Tests"

Yes - we've discussed it previously.

I'm generally a supporter of the GLP, who have done good work in rooting out government corruption in the current crisis (which is widespread). However, I think they're onto a loser with this particular application for judicial review. I don't think it really has legs and I'm relatively confident that the courts will find in favour of the government in this particular case, as I feel the exigencies of the situation warranted the actions taken (which was not the case in many of the other contracts that were awarded).

"Contract award is dated 2/11"

No it's not. The OJEU notice is dated 02/11/2020. The Contract was concluded on 13/03/2020 as the notice makes clear.

This is a retrospective OJEU notice (there's been quite a few of those).