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"surely the takeaway for ODX is that “desktop reviews” of company’s own data will be satisfactory.
So Mologic being rejected by PD becomes irrelevant.
Govt can ramp up UK production with either Mologics test, or Avacta’s, or both"

No. People are conflating two processes.

The consultation was in relation to proposals to introduce new requirements for professional use tests that were/are being sold to the public by companies (i.e. not DHSC/NHS/PHE/ONS tests). It was about adding a further step to get marketing authorisation for professional use.

The PHE Porton Down process is a separate process, aimed primarily at two things: providing HMG/DHSC with air cover for their EUAs and for identifying tests that may be suitable for non-professional use (as SE/UKCA marking only applies to professional use).

The challenges to the PHE PD process are separate from this consultation. I don't believe that this consultation will add anything to those challenges.

I personally think that the challenges to the PHE PD process will bear fruit for some developers/manufacturers (particularly Mologic) but may not have the desired results for other (e.g. Those Who Must Remain Nameless).

I'll go back to what I've been saying from the beginning. I'm in ODX for the long term and I'm talking years - not months. This is a company that has carefully positioned itself to be a cornerstone of UK and European LFT manufacturing and this will pay dividends in the medium to long term.

"Volz machine can produce the mask OK as far as I'm aware. For whatever reason our Lemu machine has issues"

Yep. Volz has a machine that works. But, as the company confirmed via RNS (rather than some interview) on 5 May, Volz will only be manufacturing on an 'order-by-order' basis, rather than on an ongoing, continuous basis.

What is desperately needed is a substantive and competent CEO, with medical devices experience. And a competent marketing function that doesn't rely on amateurs sending mask to companies uninvited. If we can get those, we stand a good chance. Unfortunately, progress on both is uncomfortably slow.

"All equipment requires specialist equipment to produce.

It’s another layer - not that difficult."

Not that difficult, eh? Remind me, how long has the machine not been working at full capacity?

Listen to yourself and give your head a little shake...

"Do you deny regulator that manufacturing most things can be done in multiple countries across the world for less than in the UK?"

Nobody is denying that. What I am suggesting is that it is not a formal position of the company. If it was, then the board would have made that position clear.

And it's not just 'a mask' - it's a mask that currently requires specialist equipment to manufacture (specialist equipment that doesn't always works correctly). That means a substantial investment for someone in India... on the hope that they can sell enough to recoup their investment.

As I say, Gareth Cave is an OK academic - he's not demonstrated any particular skills as a businessman to date...

"Who do you think the 'consumers' are, if they're not Joe Public? i.e. Home use Joe Public"

Err... no. If you actually read the consultation (as I did before responding to it on behalf of my organisation) this isn't about 'home use' - it's about ensuring that when people purchase a test from a company that what they are getting is reliable.

At the time the consultation was undertaken, the tests in scope were 'sample at home and return for analysis', i.e. it fell within the scope of professional use. It was not in relation to LFTs for home use. In part it was as a response to criticism of their proposals for travel-related testing (as a number of companies were found to have been selling tests that were not fit for purpose).

As tecbadger says, this is also a prelude to the government shifting the cost of wider testing from DHSC (via the NHS and PHE).

"...and I can see this mask being the norm for the medical world. Just my humble opinion"

As has been explained many times previously, the scope for this mask in healthcare is relatively small, given IPC requirements.

"Gareth cave said it in the last interview."

So it's not a formal company position then, is it?

Frankly, as an academic Gareth Cave is OK - but as a director he's not far off useless.

"The machine isn’t important, they’ve said they’ll be using it to develop prototypes, they have a contract to produce with Voltz."

You might be more credible if you got the name of the company right... it's Volz - not Voltz.

"It's not relevant , the machine will only be used for samples because they've already stated they can manufacture the mask anywhere in the world for far cheaper than at bio city."

Where did the company say that?

"Part of the proceeds from this order will be invested by P2F into a marketing campaign within India to support VKE and build demand for the Pro-Larva mask, which is expected to then lead to increasing repeat orders"

Problem is that, with this company, what is 'expected' often doesn't materialise.

The other issue is satisfying any demand. Difficult to do with a machine that still isn't working properly (and Volz seem to have exited stage left).

As I said - a welcome first step... but experience would suggest that caution should be exercised.

This deal is a drop in the ocean.
Whilst the masks can be sold to the public in India, to be used within the Indian healthcare system they'll have to go through a very lengthy and bureaucratic system (which makes MHRA look like a stroll in the park).
Cost will be a significant barrier for most Indians. Only the wealthiest will be able to purchase these initially (until the company can find a way of reducing the costs without impacting quality).
This deal comes with costs and any profit on this order is likely to be wiped out by the requirement to fund the advertising in India.
To go beyond this size of order will require significant investment in production capacity - and they still haven't got the machine working properly yet.

I predict a bounce in the SP as the Kool-Aiders see this as the second coming and buy in the fervent belief that they be milllionaires in a month... but they will be disappointed. This is a welcome first step... but it's just that - the first step. And there's still plenty to trip the board up - particularly the lack of a substantive, experienced CEO and a lack of marketing competency.

"Consultation Outcome – We don’t need to pass PD for Home-Use!"

That's not what the consultation says.

The consultation was on the validation of tests being offered by private providers (i.e. do we need to ensure people aren't being ripped off by unscrupulous companies using dodgy tests). It was nothing to do with 'home testing' in the sense of the public using LFTs.

"Thanks. I originally did it in the hope that Andrew Neil's new GB News might be interested - but I've heard nothing back from him. "

Gammon Broadcasting News is basically the Tory Party playing at being broadcasters...

Another plonker to pop in the green bin...

*'what' not 'with'

Some people may find it helpful to understand with a high PCR Ct count actually means...

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/926410/Understanding_Cycle_Threshold__Ct__in_SARS-CoV-2_RT-PCR_.pdf

Also worth noting "Ct values cannot be directly compared between assays of different types due to variation in the sensitivity (limit of detection), chemistry of reagents, gene targets, cycle parameters, analytical interpretive methods, sample preparation and extraction techniques"

The trolls are obviously in a frenzy. Must be sad to be so inadequate and unfulfilled...

Well, it's three days post-booster jab and no side effects to date. Even did a 12 mile hike yesterday.

"We shall see what a legend you are soon hopefully:-))"

You misspelt '*******'...

"Are you nervous now after this long time? "

No. One year isn't a 'long time' in investing - it's very much 'short term'.