Member Info for RegulatorUK

"From the LFT DPS Information document.
'The first procurements under this DPS are indicatively scheduled to commence on or around Wednesday 7 April 2021.'
Have I missed anything?"

No. DHSC will have to decide who is going to be admitted to the DPS framework, notify them and have a standstill period (10 days). So I won't expect any concrete news, by way of CANs, for a couple of weeks. That won't stop the Twitter rumour mill though...

Absolutely correct. Although it is unfortunate this is being branded in the media as a case against Abingdon, this may work in our best interests in the longer term.

I'm not sure it's the strongest case but I think it will be important in setting boundaries as to what is acceptable in exercising emergency powers and potentially in the scope of interpretation of the Article 32 exemptions in procurement. In any event will impact/curtail the corrupt government processes that have riddled the Covid pandemic... and that can only benefit us.

"I think there is good news about the tender closed on April 7th, twitter."

I'm sure there's all sorts of rumours on Twitter about that DPS tender... but I doubt we'll be getting concrete news for a while, due to the standstill period.

It's interesting that several of the larger pharmacy chains don't currently appear to be signed up to the 'collect from a pharmacy' scheme. I wonder if they're still negotiating terms...?

"Interesting that they have a link from their webpage to the govt website,are we manufacturing for them?

https://avacta.com/diagnostics/products/"

They actually have to have a test that has passed the clinical testing stage and is validated before we can manufacture it. As far as I am aware they are not yet at that stage.

I don't think that this tender is going to affect ODX particularly. It's mainly related to lab based testing.

It's not a Contract. It's a tender for a DPS framework, that was published on 8 March:
https://www.find-tender.service.gov.uk/Notice/004622-2021

It closed today. Once successful bidders are chosen, they'll have to be notified and once the standstill period is complete, you'd expect to see Contract Award Notices published (bearing in mind that DHSC have form for publishing those late).

"It's because the tweet caused people to think this was significant news, whereas the RNS stated that the approval was just required due to changes in legislation (perhaps Brexit)."

You are correct - the legislative changes are due to Brexit. The UK is continuing to accept CE marking, in addition to/instead of UKCA marking, until 31 December 2021.

"Spoke to a doctor today wearing our mask and she was unaware of them"

How do you know it was our mask? Lots of people thought Boris was wearing one of our masks on his recent visit to AZ when he wasn't (which was clear if you actually looked closely at the mask he was wearing).

"There are far more cleverer and knowledgeable people than you and me looking at this right now."

I do hope that this is true - I'm not convinced it is.

In any event, the BoD need to be laying out clearly to shareholders how they are addressing both the capacity and marketing/business development issues, rather than allowing the product's reputation to be undermined by the amateur marketing of their current distributors.

"Regulator uk .
Why are we not selling in Boots , asda, sainsbury , Tesco , Waitrose etc. We have spainish machine which is operating 8 hour shift. Have the BOD spoken to them ?"

AS Lp160606 says, those sorts of organisations are not going to stock this mask without guaranteed supply - and one machine running 8 hours a day (and not even at full capacity for those 8 hours) is not going to do it.

We could potentially push forward with the Volz deal but that also seems to have ground to a halt. Even if we did, we'd have to factor in the JIT supply chain issues that have arise since Brexit.

I really want RMS to succeed with this mask, as I have a significant holding - but we have to be realistic in our expectations. Unfortunately, I don't think that presently the BoD is really helping things but not explaining how it will address the capacity and marketing issues.

"RegulatorUK, please tell how realistic should I be? You don’t think an MHRA approval would get contracts from the NHS and DHSC? What do you think of the medical staff’s reaction, let alone the public’s if this wouldn’t be the case? 122,000 such staff are off work due to covid, as per the guardian last week. And why would the NHS and DHSC not order a unique covid killing mask? Aren’t they spending £100s billion to fight covid? Plus Matt Han**** liked p2f tweet mask few months back. So may be he was waiting this approval to instruct his department to make the orders. Wouldn’t you if had that responsibility? He is accountable to his nhs staff and the public at large who will be up in arms were they to learn of this mask and no purchase from the NHS or DHSC."

Matt Han**** is the Secretary of State for Health. He is not accountable to NHS staff - he's accountable to Parliament and his electorate, who frankly don't give a f**k which is why he got elected.

I have previously explained by I don't believe that the NHS is going to be a significant market for our mask. I'm not going to rehash that yet again, but it comes down to two main factors:
- the need for a 7 hour mask is limited in healthcare for a variety of reasons (e.g. IPC requirements)
- the price is currently far more than the NHS can afford (there is no magic money tree despite what Rishi Sunak says)

There are substantial markets where a 7 hours mask would be in demand, such as travel, service industries, office based employment and education. But it would appear that RMS is lacking the focus to properly exploit those markets.

Instead, we have deals announced (e.g. with FM London) that appear to wither on the vine and we have amateur distributors undertaking silly marketing stunts that risk undermining the credibility of the brand. The BoD needs to get a grip on marketing and business development, to ensure that the correct markets are properly tapped into and the brand enhanced. If/when they do that, we can get expect to see significant income being generated.

"Topgun ...you are very transparent fella. Obvious what your game is with the same thread titles as yesterday... Pond life lol"

Morning Benny! I see we have another plonker to put in the green bin...

“ Very big achievement and certainly the NHS and DHSC contracts should follow very soon too.”

I think you need to be a little more realistic...

No.

The photo taken at his visit to AZ, he was wearing a white mask but no one of ours. A different design if you look at the border of the mask that he was wearing and the pleating structure. He'd has been given it to wear by AZ, along with the lab coat.

"Apparently an enema kit is a class 1 device ."

Yep - but in most cases these days 'Class 1 - Sterile'.

"If it's class 1 then it has been downgraded and not good news. This is definitely fluff. Just Google medical class 1, 2 and 3."

I think you're confusing Medical Device classes (Classes 1 - 3 in the UK/EU) and mask types (Type I, Type IR, Type II, Type IIR, FFP2, FFP3, N95).

Most masks (irrespective of type) are Class 1 Medical Devices.

This has not been 'downgraded'.

"Developed & manufactured in the U.K. and used by U.K. Government Hospital Trusts."

That is what one web-site is claiming. I see no evidence that the claim is true.

I am not aware of the NHS looking to procure this mask. It's not, as far as I am aware, being formally trialed in any NHS hospitals. NHS Supply Chain doesn't have it in their catalogue.

As I've said previously, I think the main market for this will be the service and transport sectors, and potentially for office workers. And that's a huge market.

But the board need to get a proper grip on production, marketing and distribution this. At the moment, there are potentially misleading claims being made by a variety of sources, and some silly stunts being pulled by distributors. This sort of thing can fundamentally undermine public and - more importantly - professional trust in the product.

If/when the board get a grip and get a concise, accurate and targeted marketing campaign going this should fly!

"there is news
https://twitter.com/pro_larva/status/1379791718736920576"

Hmmm... slightly misleading tweet there. In the case of Class 1 medical devices there is no 'MHRA approval' as such. The item is CE/UKCA marked and then registered with MHRA, which in turn leads to MHRA marketing authorisation/approval. The device itself is not 'approved' by MHRA.

A helpful explanation here of the regulatory structure for anyone who's interested (https://support.ce-check.eu/hc/en-us/articles/360008712879-Classification-Of-Medical-Devices-And-Their-Routes-To-CE-Marking ):

"Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. If your product is class I, and it’s not a sterile or measuring device, then all you need to do is to self-certificate it, and formally declare its compliance with the applicable requirements of the MDD via a written statement. If it’s a sterile* or a measuring medical device, then you will need a Notified body assessment."

*These masks will not be classed as sterile devices.